SMART DENTURE CONVERSIONS ASF-001 Series Separable Fastener
Training:
The following descriptions are insufficient to allow immediate use of the Smart Denture Conversions’ system. Knowledge of implant-prosthetic treatment and instruction in the handling of the Smart Denture Conversions’ system provided by an operator with the relevant experience are necessary. It is strongly recommended that new and experienced users of Smart Denture Conversions’ products complete special training before using a new product for the first time. Smart Denture Conversions offers a variety of training options. Please go the www.SmartDentureConversions.com for more information.
Product Description:
The Smart Denture Conversions’ Separable Fastener secures the TiBase to the multi-unit abutment the same way as a prosthetic screw, except the PEEK Cap (screw head) and the Threaded Post are designed to separate, allowing the denture to be removed from the mouth. The PEEK Cap will disengage and remain in the TiBase for the pickup while the Threaded Post remains in the multi-unit abutment. Smart Denture Conversions’ Separable Fasteners are offered in two sizes across 6 styles. The table below summarizes the items:
| Name | Part
Number |
Compatible
TiBase |
Material | # of Uses |
| Standard Separable Fastener, Unigrip | ASF-001 | SF-003 |
300 Series Stainless Steel And Unfilled PEEK (Poly-Ether Ether Ketone) |
Single |
| Tall Separable Fastener, Unigrip | ASF-001L | SF-004 | ||
| Standard Separable Fastener, Extended Thread | ASF-002 | SF-003 | ||
| Tall Separable Fastener, Extended Thread | ASF-002L | SF-004 | ||
| Standard Separable Fastener, Tilobe | ASF-003 | SF-003 | ||
| Tall Separable Fastener, TiLobe | ASF-003L | SF-004 | ||
| Standard Separable Fastener, Paltop | ASF-004 | PT-003 | ||
| Tall Separable Fastener, Paltop | ASF-004L | PT-004 | ||
| Standard Separable Fastener, 0.05” Hex | ASF-005 | SF-003/SF-012 | ||
| Tall Separable Fastener, 0.05” Hex | ASF-005L | SF-004/SF-012L | ||
| Standard Separable Fastener, Omnibut | ASF-006 | OA-003 | ||
| Tall Separable Fastener, Omnibut | ASF-006L | OA-003L |
Indications for Use
Separable Fasteners are indicated for use with Smart Denture Conversions’ TiBases and screw-retained multiple-unit Abutments in the maxilla and mandible. Standard Separable Fasteners should be used with Standard TiBases and Tall Separable Fasteners should be used with Tall TiBases. Separable Fasteners are designed to withstand enough torque to hold the TiBase to the multi-unit abutment, Lab Analog or Coating Mandrel, but not too much to prematurely separate the Separable Fastener. Smart Denture Conversions’ Separable Fasteners are intended for single use. Re-use of single use devices creates a potential risk of patient or user infection and misfitting components. For more specific information on process steps, please refer to the Technique manual located on the website www.SmartDentureConversions.com
Separable Fastener
Note: It is suggested to use the Torque Driver to properly tighten the Separable Fastener and the axis’ must be properly aligned to ensure the proper amount of torque is transferred while tightening. Applying too much torque when tightening the Separable Fastener can cause the threaded post to continue to screw into the mating component and cause the PEEK Cap to separate. To correct this, ensure the top of the threaded section of the Threaded Post is flush with the top of the MUA. This can be done either by hand or by using the Retrieval Tool in a contra angle. With the Threaded Post at the proper height, the Peek Cap can simply be pressed back on, then turned clockwise slightly to ensure a snug fit.
Contraindications
It is contraindicated to using Smart Denture Conversions’ Separable Fasteners in:
- Patients who are medically unfit for an oral surgical procedure.
- Patients in whom adequate sizes, numbers or desirable positions of implants are not reachable to achieve safe support of functional or eventually parafunctional loads.
- Patients who show signs of allergy or hypersensitivity to the chemical components of the materials listed in the chart above.
Warning:
- Components are to be used by dental health care professionals and are to be used in patients subject to dental implant treatment.
- If the indication or the nature of use is not clear, do not use until all points have been clarified.
- Do not use if package is damaged.
- Always inspect components before use. Do not use damaged, deformed, corroded, or discolored components.
- Ensure products are secured against aspiration when handled intraorally. Aspiration of products may lead to infection or unplanned physical injury.
- Failure to follow the procedures outlined in these instructions may lead to any or all of the following complications: Aspiration or swallowing of a component, follow-up treatment, incorrect impression resulting in incompatible restorations.
- As the clinical outcome of dental treatment is influenced by multiple variables, even if the product is used according to the instructions for use the residual risks described below can. anaphylaxis (severe allergic reaction); aspiration or swallowing of components; pain; local infection; inflammation; local irritation; loss of product function; follow-up treatment.
- Smart Denture Conversions is not liable for damage resulting from use outside the intended use of the product.
Cautions/Precautions:
The following precautions are required before or during treatment:
- Do not use Smart Denture Conversion components after the expiration date on packaging (if applicable).
- All products intended for single use must not be reused. Re-use of single use devices creates a potential risk of patient or user infection and misfitting components.
- Before every procedure make sure that all required components, instruments, and auxiliary equipment are complete, in operating order and available in the required quantity.
- If, due to unfavorable anatomical conditions, instruments do not fit or cannot be used for other reasons, the course of treatment planned with them must not be continued and alternatives must be sought.
- Always wear suitable personal protective equipment for your own safety.
- Position the patient such that the danger of aspiration of components is minimized.
- All components used in the patient’s mouth must be secured to prevent aspiration and swallowing.
Magnetic Resonance Imaging (MRI) Safety Information:
All Smart Denture Conversion LLC products which remain in the patient’s body have not been evaluated for safety and compatibility in the MR environment. They have not been tested for heating, migration, or image artifact in the MR environment. The safety of the Smart Denture Conversion LLC products in the MR environment is unknown. Scanning a patient who has such a product may result in patient injury.
Sterilization Instructions:
Components are delivered non-sterile by Smart Denture Conversions and are intended for single use. Prior to use, the devices must be sterilized by the user.
Smart Denture Conversions recommends the following procedure for sterilization prior to use. Sterilization is recommended to be performed corresponding to the following scheme:
- Preparation for sterilization: Place components (up to 6 devices) in a sterilization pouch which is FDA-cleared for the intended cycle.
- Sterilization:
| Method | Cycle | Temperature | Exposure Time* | Dry Time |
| Steam | Dynamic Air Removal
(Prevacuum) |
132°C (270°F) | 4min | 20min |
| Steam | Gravity Displacement | 121°C (250°F) | 30min | 30min |
*Minimum exposure times, the operating times are longer and may vary depending on the device.
Storage, Handling and Transportation:
The devices must be stored in a dry place in their original packaging at room temperature and protected from direct sunlight. Improper storage may compromise essential material and design characteristics, leading to device failure.
Disposal
Safely discard potentially contaminated or no longer usable medical devices as healthcare (clinical) waste in accordance with local healthcare guidelines, country and government legislation or policy. Separation, recycling or disposal of packaging material shall follow local country and government legislation on packaging and packaging waste, where applicable. If there is no current legislation, pack them in a perforating waste/sharps disposal container and dispose of them in hospital waste.
Basic UDI-DI Information:
The following table lists the Basic UDI-DI information for the devices described in this IFU.
| Product | Catalog Number | Included Parts | Basic UDI-DI Number |
| Separable Fastener 10-Pack | SF10PK | ASF-001 | +D990SF10PK0 |
| Tall Separable Fastener 10-Pack | TSF10PK | ASF-001L | +D990TSF10PK0 |
| Separable Fastener 10PK, Ext. Thread | TFMV-SF10PK | ASF-002 | +D990TFMV-SF10PK0 |
| Tall Separable Fastener 10PK, Ext. Thread | TFMV-TSF10PK | ASF-002L | +D990TFMV-TSF10PK0 |
| Tall Separable Fastener 10-Pack, w/
Cementation Aid, Ditron |
DDUS-
TSFCA10PK |
ASF-001L | +D990DDUS-TSFCA10PK0 |
| Separable Fastener 10PK, TiLobe (Quad
Drive) |
KDTL-SF10PK | ASF-003 | +D990KDTL-SF10PK0 |
| Separable Fastener, Tall 10PK, TiLobe
(Quad Drive) |
KDTL-TSF10PK | ASF-003L | +D990KDTL-TSF10PK0 |
| Separable Fastener 10PK, Paltop (IHex) | KDIH-SF10PK | ASF-004 | +D990KDIH-SF10PK0 |
| Separable Fastener, Tall 10PK, Paltop
(IHex) |
KDIH-TSF10PK | ASF-004L | +D990KDIH-TSF10PK0 |
| Separable Fastener 10PK, 0.05″ Hex | FZMF-SF10PK | ASF-005 | +D990FZMF-SF10PK0 |
| Tall Separable Fastener 10PK, 0.05” Hex | FZMF-TSF10PK | ASF-005L | +D990FZMF-TSF10PK0 |
| Tall Spare Parts Kit, 0.05” Hex | FZMF-TSP | ASF-005L | +D990FZMF-TSP0 |
| Premium Starter Kit, SDC | PSK | ASF-001/ASF-001L | +D990PSK0 |
| Starter Kit, SDC | SK | ASF-001/ASF-001L | +D990SK0 |
| Recharge Kit w/ Tall Spare Parts, SDC | RK | ASF-001/ASF-001L | +D990RK0 |
| Recharge Kit w/ POC, SDC | RKPOC | ASF-001 | +D990RKPOC0 |
| Separable Fastener Assembly 10-pack
with Drill kit |
SFA10PKDK | ASF-001 | +D990SFA10PKDK0 |
| Tall Spare Parts Kit, SDC | TSP | ASF-001L | +D990TSP0 |
| Premium Starter Kit, Straumann | PSK-ST | ASF-002/ASF-002L | +D990PSK-ST0 |
| Starter Kit, Straumann | SK-ST | ASF-002/ASF-002L | +D990SK-ST0 |
| Recharge Kit w/ Tall Spare Parts,
Straumann |
RK-ST | ASF-002/ASF-002L | +D990RK-ST0 |
| Recharge Kit w/ POC, Straumann | RKPOC-ST | ASF-002 | +D990RKPOC-ST0 |
| Separable Fastener Assembly 10-pack
with Drill kit, Straumann |
SFA10PKDK-ST | ASF-002 | +D990SFA10PKDK-ST0 |
| Tall Spare Parts Kit, Straumann | TSP-ST | ASF-002L | +D990TSP-ST0 |
| Premium Starter Kit, TiLobe | KDTL-PSK | ASF-003/ASF-003L | +D990KDTL-PSK0 |
| Starter Kit, TiLobe | KDTL-SK | ASF-003/ASF-003L | +D990KDTL-SK0 |
| Recharge Kit w/ Tall Spare Parts, TiLobe | KDTL-RK | ASF-003/ASF-003L | +D990KDTL-RK0 |
| Recharge Kit w/ POC, TiLobe | KDTL-RKPOC | ASF-003 | +D990KDTL-RKPOC |
| Separable Fastener Assembly 10-pack
with Drill Kit, TiLobe |
KDTL-SFA10PKDK | ASF-003 | +D990KDTL-SFA10PKDK0 |
| Tall Spare Parts Kit, TiLobe | KDTL-TSP | ASF-003L | +D990KDTL-TSP0 |
| Premium Starter Kit, Paltop | KDIH-PSK | ASF-004/ASF-004L | +D990KDIH-PSK0 |
| Starter Kit, Paltop | KDIH-SK | ASF-004/ASF-004L | +D990KDIH-SK0 |
| Recharge Kit w/ Tall Spare Parts, Paltop | KDIH-RK | ASF-004/ASF-004L | +D990KDIH-RK0 |
| Recharge Kit w/ POC, Paltop | KDIH-RKPOC | ASF-004 | +D990KDIH-RKPOC0 |
| Separable Fastener Assembly 10-pack
with Drill kit, Paltop |
KDIH-SFA10PKDK | ASF-004 | +D990KDIH-SFA10PKDK0 |
| Tall Spare Parts Kit, Paltop | KDIH-TSP | ASF-004L | +D990KDIH-TSP0 |
| Premium Starter Kit, BioHorizons | BHHD-PSK | ASF-005/ASF-005L | +D990BHHD-PSK0 |
| Starter Kit, BioHorizons | BHHD-SK | ASF-005/ASF-005L | +D990BHHD-SK0 |
| Recharge Kit w/ Tall Spare Parts,
BioHorizons |
BHHD-RK | ASF-005/ASF-005L | +D990BHHD-RK0 |
| Recharge Kit w/ POC, BioHorizons | BHHD-RKPOC | ASF-005 | +D990BHHD-RKPOC0 |
| Separable Fastener Assembly 10-pack
with Drill kit, BioHorizons |
BHHD-
SFA10PKDK |
ASF-005 | +D990BHHD-SFA10PKDK0 |
| Premium Starter Kit, TSV | ZVTS-PSK | ASF-005/ASF-005L | +D990ZVTS-PSK0 |
| Premium Starter Kit, Low Profile | ZVLP-PSK | ASF-005/ASF-005L | +D990ZVLP-PSK0 |
| Recharge Kit w/ Tall Spare Parts, TSV | ZVTS-RK | ASF-005/ASF-005L | +D990ZVTS-RK0 |
| Recharge Kit w/ Tall Spare Parts, Low
Profile |
ZVLP-RK | ASF-005/ASF-005L | +D990ZVLP-RK0 |
| Recharge Kit w/ POC, TSV | ZVTS-RKPOC | ASF-005 | +D990ZVTS-RKPOC0 |
| Recharge Kit w/ POC, Low Profile | ZVLP-RKPOC | ASF-005 | +D990ZVLP-RKPOC0 |
| Separable Fastener 10PK, ZimVie | ZV-SF10PK | ASF-005 | +D990ZV-SF10PK0 |
| Tall Separable Fastener 10PK, ZimVie | ZV-TSF10PK | ASF-005L | +D990ZV-TSF10PK0 |
| Separable Fastener Assembly 10PK – Drill
Kit Included, TSV |
ZVTS-SFA10PKDK | ASF-005 | +D990ZVTS-SFA10PKDK0 |
| Separable Fastener Assembly 10PK – Drill
Kit Included, Low Profile |
ZVLP-SFA10PKDK | ASF-005 | +D990ZVLP-SFA10PKDK0 |
| Separable Fastener 10-Pack, Omnibut | SF10PK-OA | ASF-006 | +D990SF10PK-OA0 |
| Tall Separable Fastener 10-Pack, Omnibut | TSF10PK-OA | ASF-006L | +D990TSF10PK-OA0 |
| Premium Starter Kit, Omnibut | PSK-OA | ASF-006/ASF-006L | +D990PSK-OA0 |
| Recharge Kit w/ Tall Spare Parts, Omnibut | RK-OA | ASF-006/ASF-006L | +D990RK-OA0 |
| Recharge Kit w/ POC, Omnibut | RKPOC-OA | ASF-006 | +D990RKPOC-OA0 |
| Separable Fastener Assembly 10-pack
with Drill kit, Omnibut |
SFA10PKDK-OA | ASF-006 | +D990SFA10PKDK-OA0 |
| Tall Spare Parts Kit, Omnibut | TSP-OA | ASF-006L | +D990TSP-OA0 |
Validity:
Upon publication of these instructions for use, all previous versions are superseded.
Availability:
Some items of Smart Denture Conversions are not available in all countries.
Warranty:
Please visit www.SmartDentureConversions.com for the most up to date warranty information.
Symbols Glossary:
The following Symbols may be present on the device labeling or in information accompanying the device. Refer to the device labeling or accompanying information for the applicable symbols.
Manufacturer:
Smart Denture Conversions, LLC
1800 N. Salem St.
Suite 104
Apex NC, 27523
855-550-0707 www.SmartDentureConversions.com
Documents / Resources
 |
SMART DENTURE CONVERSIONS ASF-001 Series Separable Fastener [pdf] Instruction Manual ASF-001, ASF-001L, ASF-002, ASF-002L, ASF-003, ASF-003L, ASF-004, ASF-004L, ASF-005, ASF-005L, ASF-006, ASF-006L, ASF-001 Series Separable Fastener, ASF-001 Series, Separable Fastener, Fastener |
