TiBase Smart Denture Conversions System Instruction Manual
Instructions for Use (IFU)
Manufacturer:
Smart Denture Conversions, LLC
1800 N. Salem St.
Suite 104
Apex NC, 27523
855-550-0707
www.SmartDentureConversions.com
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:
Smart Denture Conversions’ TiBases are picked up in the denture or prosthesis as an interface with the multi-unit
abutment. They provide the screw seat for the Prosthetic Screw. Smart Denture Conversions’ Temporary TiBases are offered in four formats and two heights, for a total of 8 TiBases. Cementable TiBases are offered in two formats.
The table below summarizes the different types:
| Name | Part Number | Approx Height | Material | # of Uses |
| Standard Ti Base, SDC | SF-003 | 4.6mm | Titanium alloy –Ti-6AI-4V ELI(90% Ti, 6% Al, 4% V ELI) | Single |
| Tall Ti Base, SDC | SF-004 | 6.1mm | ||
| Cementable Ti Base, SDC | SF-006 | 5.3mm | ||
| Standard Ti Base, Paltop | PT-003 | 4.6mm | ||
| Tall Ti Base, Pal top | PT-004 | 6.1mm | ||
| Standard TiBase, TSV | SF-012 | 4.6mm | ||
| Tall TiBase, TSV | SF-012L | 6.1mm | ||
| Standard TiBase, Omnibut | OA-003 | 4.6mm | ||
| Tall TiBase, Omnibut | OA-003L | 6.1mm | ||
| Cementable Ti Base, Omni but | OA-006 | 5.3mm |
Indications for Use:
Ti Bases are indicated for use with screw-retained multiple-unit abutments in the maxilla and mandible. Standard TiBases should be used when at least 75% of the TiBase can be embedded into acrylic during the pickup. When the tissue is not accommodating for Standard TiBases, Tall TiBases can be used for proper pickup. Cementable TiBases are preferred when a prosthesis is manufactured with precise pockets for cementation of a TiBase. Smart Denture Conversions’ TiBases are intended for single use. Re-use of single use devices creates a potential risk of patient or user infection and mis fitting components. For more specific information on process steps, please refer to the
Technique manual located on the website www.SmartDentureConversions.com.
Contraindications:
It is contraindicated to using Smart Denture Conversions’ TiBases 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.
- Overtightening may cause the TiBase or other components to become deformed, broken or stuck on the implant analog or abutment, resulting in damage to 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 components, follow-up treatment, incorrect impression resulting in incompatible restorations.
- Even if the product is used according to the instructions for use, the clinical outcome of dental treatment is influenced by multiple variables and may lead to any or all of the following complications: 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.
- Ensure that the abutment surface is clean before placing TiBases.
- 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.
- Observe specified torques.
Magnetic Resonance Imaging (MRI) Safety Information:
All Smart Denture Conversion 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 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 |
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.
Assembly and UDI 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 |
| Standard TiBase 10-Pack | STB10PK | SF-003 | +D990STB10PK0 |
| Tall TiBase 10-Pack | TTB10PK | SF-004 | +D990TTB10PK0 |
| Premium Starter Kit, SDC | PSK | SF-003/SF-004 | +D990PSK0 |
| Starter Kit, SDC | SK | SF-003/SF-004 | +D990SK0 |
| Recharge Kit w/ Tall Spare Parts, SDC | RK | SF-003/SF-004 | +D990RK0 |
| Recharge Kit w/ POC, SDC | RKPOC | SF-003 | +D990RKPOC0 |
| Separable Fastener Assembly 10-pack withDrill kit | SFA10PKDK | SF-003 | +D990SFA10PKDK0 |
| Tall Spare Parts Kit, SDC | TSP | SF-004 | +D990TSP0 |
| Premium Starter Kit, Straumann | PSK-ST | SF-003/SF-004 | +D990PSK-ST0 |
| Starter Kit, Straumann | SK-ST | SF-003/SF-004 | +D990SK-ST0 |
| Recharge Kit w/ Tall Spare Parts, Straumann | RK-ST | SF-003/SF-004 | +D990RK-ST0 |
| Recharge Kit w/ POC, Stroman | RKPOC-ST | SF-003 | +D990RKPOC-ST0 |
| Tall Spare Parts Kit, Straumann | TSP-ST | SF-004 | +D990TSP-ST0 |
| Separable Fastener Assembly 10-pack with Drill kit, Stroman | SFA10PKDK-ST | SF-003 | +D990SFA10PKDK-ST0 |
| Premium Starter Kit, TiLobe | KDTL-PSK | SF-003/SF-004 | +D990KDTL-PSK0 |
| Starter Kit, TiLobe | KDTL-SK | SF-003/SF-004 | +D990KDTL-SK0 |
| Recharge Kit w/ Tall Spare Parts, TiLobe | KDTL-RK | SF-003/SF-004 | +D990KDTL-RK0 |
| Recharge Kit w/ POC, TiLobe | KDTL-RKPOC | SF-003 | +D990KDTL-RKPOC0 |
| Separable Fastener Assembly 10-pack withDrill Kit, TiLobe | KDTL-SFA10PKDK | SF-003 | +D990KDTL-SFA10PKDK0 |
| Tall Spare Parts Kit, Ti Lo be | KDTL-TSP | SF-004 | +D990KDTL-TSP0 |
| Premium Starter Kit, Pal top | KDIH-PSK | PT-003/PT-004 | +D990KDIH-PSK0 |
| Starter Kit, Pal top | KDIH-SK | PT-003/PT-004 | +D990KDIH-SK0 |
| Recharge Kit w/ Tall Spare Parts, Pal top | KDIH-RK | PT-003/PT-004 | +D990KDIH-RK0 |
| Recharge Kit w/ POC, Pal top | KDIH-RKPOC | PT-003 | +D990KDIH-RKPOC0 |
| Separable Fastener Assembly 10-pack withDrill kit, Pal top | KDIH-SFA10PKDK | PT-003 | +D990KDIH-SFA10PKDK0 |
| Tall Spare Parts Kit, Pal top | KDIH-TSP | PT-004 | +D990KDIH-TSP0 |
| Standard TiBase 10-Pack, Pal top (I-Hex) | KDIH-STB10PK | PT-003 | +D990KDIH-STB10PK0 |
| Tall TiBase 10-Pack, Paltop (I-Hex) | KDIH-TTB10PK | PT-004 | +D990KDIH-TTB10PK0 |
| Premium Starter Kit, Bio Horizons | BHHD-PSK | PT-003/PT-004 | +D990BHHD-PSK0 |
| Starter Kit, Bio Horizons | BHHD-SK | PT-003/PT-004 | +D990BHHD-SK0 |
| Recharge Kit w/ Tall Spare Parts, Bio Horizons | BHHD-RK | PT-003/PT-004 | +D990BHHD-RK0 |
| Recharge Kit w/ POC, BioHorizons | BHHD-RKPOC | PT-003 | +D990BHHD-RKPOC0 |
| Separable Fastener Assembly 10-pack withDrill kit, BioHorizons | BHHD-SFA10PKDK | PT-003 | +D990BHHD-SFA10PKDK0 |
| Tall Spare Parts Kit, 0.05” Hex | FZMF-TSP | SF-004 | +D990FZMF-TSP0 |
| Premium Starter Kit, TSV | ZVTS-PSK | SF-003/SF-004 | +D990ZVTS-PSK0 |
| Premium Starter Kit, Low Profile | ZVLP-PSK | SF-012/SF-012L | +D990ZVLP-PSK0 |
| Recharge Kit w/ Tall Spare Parts, TSV | ZVTS-RK | SF-003/SF-004 | +D990ZVTS-RK0 |
| Recharge Kit w/ Tall Spare Parts, Low Profile | ZVLP-RK | SF-012/SF-012L | +D990ZVLP-RK0 |
| Recharge Kit w/ POC, TSV | ZVTS-RKPOC | SF-003 | +D990ZVTS-RKPOC0 |
| Recharge Kit w/ POC, Low Profile | ZVLP-RKPOC | SF-012 | +D990ZVLP-RKPOC0 |
| Separable Fastener Assembly 10PK – Drill KitIncluded, TSV | ZVTS-SFA10PKDK | SF-003 | +D990ZVTS-SFA10PKDK0 |
| Separable Fastener Assembly 10PK – Drill KitIncluded, Low Profile | ZVLP-SFA10PKDK | SF-012 | +D990ZVLP-SFA10PKDK0 |
| Standard TiBase 10PK, TSV | ZVTS-STB10PK | SF-003 | +D990ZVTS-STB10PK0 |
| Standard TiBase 10PK, Low Profile | ZVLP-STB10PK | SF-012 | +D990ZVLP-STB10PK0 |
| Tall TiBase 10PK, TSV | ZVTS-TTB10PK | SF-004 | +D990ZVTS-TTB10PK0 |
| Tall TiBase 10PK, Low Profile | ZVLP-TTB10PK | SF-012L | +D990ZVLP-TTB10PK0 |
| Standard Omni but TiBase, 10 PK | STB10PK-OA | OA-003 | +D990STB10PK-OA0 |
| Tall Omni but TiBase, 10 PK | TTB10PK-OA | OA-003L | +D990TTB10PK-OA0 |
| Premium Starter Kit, Omni but | PSK-OA | OA-003/OA-003L | +D990PSK-OA0 |
| Recharge Kit w/ Tall Spare Parts, Omni but | RK-OA | OA-003/OA-003L | +D990RK-OA0 |
| Recharge Kit w/ POC, Omni but | RKPOC-OA | OA-003 | +D990RKPOC-OA0 |
| Separable Fastener Assembly 10-pack with Drill kit, Omni but | SFA10PKDK-OA | OA-003 | +D990SFA10PKDK-OA0 |
| Cementable TiBase 10PK, SDC | CTB10PK | SF-006 | +D990CTB10PK0 |
| Cementable TiBase 10PK, Omni but | CTB10PK-OA | OA-006 | +D990CTB10PK-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 |  |
Date of Manufacture |
 |
Use By Date |  |
Serial Number |
 |
Batch Code |  |
Catalog Number |
 |
Unique Device Identifier |  |
Medical Device |
 |
CE Mark |  |
UK Representative |
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United Kingdom Conformity Assessment Mark |  |
United Kingdom Conformity Assessment Mark with Approved Body Number |
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European Representative |  |
Non-Sterile |
 |
Comes Sterilized |  |
Comes Sterilized using Aseptic Processing |
 |
Comes Sterilized using Ethylene Oxide Processing |  |
Comes Sterilized using Irradiation Processing |
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Comes Sterilized using Dry Heat Processing |  |
Do Not Reserialize |
 |
Do Not Reuse |  |
Consult Instructions for Use |
 |
Keep Dry |  |
Keep Away from Sunlight |
| RX Only | For Prescription Use Only |  |
Caution, Consult Accompanying Documents |
 |
Do Not Use if Packaging is Damaged |
Documents / Resources
 |
SMART DENTURE CONVERSIONS TiBase Smart Denture Conversions System [pdf] Instruction Manual SF-003, SF-004, SF-006, PT-003, PT-004, SF-012, SF-012L, OA-003, OA-003L, OA-006, TiBase Smart Denture Conversions System, TiBase, Smart Denture Conversions System, Denture Conversions System |
