SMART DENTURE CONVERSIONS Lab Analog and Coating Mandrel
Specifications
- Manufacturer: Smart Denture Conversions, LLC
- Address: 1800 N. Salem St. Suite 104, Apex NC, 27523
- Contact: 855-550-0707
- Website: www.SmartDentureConversions.com
Product Usage Instructions
Storage, Handling, and Transportation
Store in a dry place at room temperature in their original packaging. Protect from direct sunlight to prevent compromise of material and design characteristics.
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
Lab Analog
The Lab Analog is designed to simulate the prosthetic side of a multi-unit abutment and can be used in a quick set stone model to create a repair jig or stone model. It is also used in packaging to hold the Separable Fastener, TiBase and Prosthetic Screw in a single unit.
- Name: Lab Analog, M1.4
- Part Number: SFT-003
- Material: 300 Series Stainless Steel
- # of Uses: Single
Coating Mandrel
The Coating Mandrel is used to hold the TiBase and Separable Fastener together, making it easier to pre coat the two components together with acrylic. Pre coating allows for an easier handle of the combined components, ensures acrylic fills all crevices for a better pickup and prevents the PEEK Cap from spinning when drilling through it later in the process. The Coating Mandrel can be held by hand or in a lab handpiece with a 2.35mm collet, run at the lowest speed setting.
The table below summarizes the items:
| Name | Part Number | Compatible Separable Fastener | Compatible Ti Bases | Compatible Prosthetic Screw | Material | # of Uses | |
| Lab Analog, M1.4 | SFT-003 | ASF-001, ASF-001L, | PS-001, PS-002, | ||||
| ASF-002, ASF-002L, | SF-003/SF-004 | PS-003, PS-005, | |||||
| Coating Mandrel, M1.4 | SFT-008 | ||||||
| ASF-003, ASF-003L, | SF-012/SF-012L | PS-006, PS-007, | |||||
| ASF-005, ASF-005L | PS-008 | 300 Series | |||||
| Lab Analog, #1-72 | PT-007 | ASF-004, ASF-004L | PT-003/PT-004 | PS-004 | Stainless | Single | |
| Coating Mandrel, #1-72 | PT-008 | Steel | |||||
| Lab Analog, Omni but | OA-008 | ||||||
| Coating Mandrel, | OA-009 | ASF-006, ASF-006L | OA-003/OA-003L | OA-506 | |||
| Omni but |
Indications for Use:
Lab Analogs and Coating Mandrels are intended for use with the compatible Smart Denture Conversions’ Separable Fastener, Prosthetic Screw and TiBases and are intended for use within the lab. Lab Analogs and Coating Mandrels are not for patient contact and 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.
Note: The Prosthetic Screw/Separable Fastener must be properly aligned with the axis of the threaded hole in the Lab Analog or Coating Mandrel. Failure to properly align the axis’ can cause damage to either or both components.
Contraindications:
It is contraindicated to using Smart Denture Conversions’ Pin Vise if:
- Operator or Patient shows signs of allergy or hypersensitivity to the chemical components of the materials listed in the chart above.
Warning:
- The supplied Lab Analog and Coating Mandrel are intended for laboratory use by a trained technician.
- 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 components to become deformed, broken or stuck resulting in damage to components.
- 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 indicated on the packaging.
- 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.
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 (Pre vacuum) 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 |
| Lab Analog 10PK | LA10PK | SFT-003 | +D990LA10PK0 |
| Coating Mandrel 6PK | CM6PK | SFT-008 | +D990CM6PK0 |
| Coating Mandrel 10PK | CM10PK | SFT-008 | +D990CM10PK0 |
| Lab Analog 10PK, Paltop | KDIH-LA10PK | PT-007 | +D990KDIH-LA10PK0 |
| Coating Mandrel 6PK, Paltop (IHex) | KDIH-CM6PK | PT-008 | +D990KDIH-CM6PK0 |
| Coating Mandrel 10PK, Paltop (IHex) | KDIH-CM10PK | PT-008 | +D990KDIH-CM10PK0 |
| Premium Starter Kit, SDC | PSK | SFT-003/SFT-008 | +D990PSK0 |
| Starter Kit, SDC | SK | SFT-003 | +D990SK0 |
| Recharge Kit w/ Tall Spare Parts, SDC | RK | SFT-003 | +D990RK0 |
| Recharge Kit w/ POC, SDC | RKPOC | SFT-003 | +D990RKPOC0 |
| Separable Fastener Assembly 10-packwith Drill kit | SFA10PKDK | SFT-003 | +D990SFA10PKDK0 |
| Premium Starter Kit, Straumann | PSK-ST | SFT-003/SFT-008 | +D990PSK-ST0 |
| Starter Kit, Straumann | SK-ST | SFT-003 | +D990SK-ST0 |
| Recharge Kit w/ Tall Spare Parts, Straumann | RK-ST | SFT-003 | +D990RK-ST0 |
| Recharge Kit w/ POC, Straumann | RKPOC-ST | SFT-003 | +D990RKPOC-ST0 |
| Separable Fastener Assembly 10-packwith Drill kit, Straumann | SFA10PKDK-ST | SFT-003 | +D990SFA10PKDK-ST0 |
| Premium Starter Kit, TiLobe | KDTL-PSK | SFT-003/SFT-008 | +D990KDTL-PSK0 |
| Starter Kit, TiLobe | KDTL-SK | SFT-003 | +D990KDTL-SK0 |
| Recharge Kit w/ Tall Spare Parts, TiLobe | KDTL-RK | SFT-003 | +D990KDTL-RK0 |
| Recharge Kit w/ POC, TiLobe | KDTL-RKPOC | SFT-003 | +D990KDTL-RKPOC0 |
| Separable Fastener Assembly 10-packwith Drill Kit, TiLobe | KDTL-SFA10PKDK | SFT-003 | +D990KDTL-SFA10PKDK0 |
| Premium Starter Kit, Paltop | KDIH-PSK | PT-007/PT-008 | +D990KDIH-PSK0 |
| Starter Kit, Paltop | KDIH-SK | PT-007 | +D990KDIH-SK0 |
| Recharge Kit w/ Tall Spare Parts, Paltop | KDIH-RK | PT-007 | +D990KDIH-RK0 |
| Recharge Kit w/ POC, Paltop | KDIH-RKPOC | PT-007 | +D990KDIH-RKPOC0 |
| Separable Fastener Assembly 10-packwith Drill kit, Paltop | KDIH-SFA10PKDK | PT-007 | +D990KDIH-SFA10PKDK0 |
| Premium Starter Kit, Bio Horizons | BHHD-PSK | SFT-003/SFT-008 | +D990BHHD-PSK0 |
| Starter Kit, Bio Horizons | BHHD-SK | SFT-003 | +D990BHHD-SK0 |
| Recharge Kit w/ Tall Spare Parts, Bio Horizons | BHHD-RK | SFT-003 | +D990BHHD-RK0 |
| Recharge Kit w/ POC, Bio Horizons | BHHD-RKPOC | SFT-003 | +D990BHHD-RKPOC0 |
| Separable Fastener Assembly 10-packwith Drill kit, Bio Horizons | BHHD-SFA10PKDK | SFT-003 | +D990BHHD-SFA10PKDK0 |
| Premium Starter Kit, TSV | ZVTS-PSK | SFT-003/SFT-008 | +D990ZVTS-PSK0 |
| Premium Starter Kit, Low Profile | ZVLP-PSK | SFT-003/SFT-008 | +D990ZVLP-PSK0 |
| Recharge Kit w/ Tall Spare Parts, TSV | ZVTS-RK | SFT-003 | +D990ZVTS-RK0 |
| Recharge Kit w/ Tall Spare Parts, Low Profile | ZVLP-RK | SFT-003 | +D990ZVLP-RK0 |
| Recharge Kit w/ POC, TSV | ZVTS-RKPOC | SFT-003 | +D990ZVTS-RKPOC0 |
| Recharge Kit w/ POC, Low Profile | ZVLP-RKPOC | SFT-003 | +D990ZVLP-RKPOC0 |
| Separable Fastener Assembly 10PK – Drill Kit Included, TSV | ZVTS-SFA10PKDK | SFT-003 | +D990ZVTS-SFA10PKDK0 |
| Separable Fastener Assembly 10PK – Drill Kit Included, Low Profile | ZVLP-SFA10PKDK | SFT-003 | +D990ZVLP-SFA10PKDK0 |
| Lab Analog 10PK, ZimVie | ZV-LA10PK | SFT-003 | +D990ZV-LA10PK0 |
| Coating Mandrel 10PK, ZimVie | ZV-CM10PK | SFT-008 | +D990ZV-CM10PK0 |
| Premium Starter Kit, Omni but | PSK-OA | OA-008/OA-009 | +D990PSK-OA0 |
| Recharge Kit w/ Tall Spare Parts, Omni but | RK-OA | OA-008 | +D990RK-OA0 |
| Recharge Kit w/ POC, Omni but | RKPOC-OA | OA-008 | +D990RKPOC-OA0 |
| Separable Fastener Assembly 10-pack with Drill kit, Omni but | SFA10PKDK-OA | OA-008 | +D990SFA10PKDK-OA0 |
| Lab Analog 10PK, Omni but | LA10PK-OA | OA-008 | +D990LA10PK0 |
| Coating Mandrel 10PK, Omni but | CM10PK-OA | OA-009 | +D990CM10PK0 |
| Coating Mandrel 6PK, Omni but | CM6PK-OA | OA-009 | +D990CM6PK0 |
- 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.
FAQs
- Q: How many times can the Lab Analog and Coating Mandrel be used?
A: Both the Lab Analog and Coating Mandrel are designed for single use only. - Q: What materials are the Lab Analog and Coating Mandrel made of?
A: The Lab Analog and Coating Mandrel are made of 300 Series Stainless Steel.
Documents / Resources
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SMART DENTURE CONVERSIONS Lab Analog and Coating Mandrel [pdf] Instruction Manual Lab Analog and Coating Mandrel, Analog and Coating Mandrel, Coating Mandrel, Mandrel |
