Instruction Manual for SMART DENTURE CONVERSIONS models including: Lab Analog and Coating Mandrel, Analog and Coating Mandrel, Coating Mandrel, Mandrel
IFUs – Smart On X
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DocumentDocumentInstructions for Use (IFU) Lab Analog and Coating Mandrel 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: 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. Coating Mandrel The Coating Mandrel is used to hold the TiBase and Separable Fastener together, making it easier to precoat the two components together with acrylic. Precoating 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 Lab Analog, M1.4 Coating Mandrel, M1.4 Lab Analog, #1-72 Coating Mandrel, #1-72 Lab Analog, Omnibut Coating Mandrel, Omnibut Part Number SFT-003 SFT-008 PT-007 PT-008 OA-008 OA-009 Compatible Separable Fastener ASF-001, ASF-001L, ASF-002, ASF-002L, ASF-003, ASF-003L, ASF-005, ASF-005L ASF-004, ASF-004L Compatible TiBases SF-003/SF-004 SF-012/SF-012L PT-003/PT-004 ASF-006, ASF-006L OA-003/OA-003L Compatible Prosthetic Screw PS-001, PS-002, PS-003, PS-005, PS-006, PS-007, PS-008 PS-004 Material 300 Series Stainless Steel OA-506 # of Uses Single 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. IFU-007 Rev F Page 1 of 6 Instructions for Use (IFU) Lab Analog and Coating Mandrel 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: 1. Preparation for sterilization: Place components (up to 6 devices) in a sterilization pouch which is FDA-cleared for the intended cycle. 2. Sterilization: Method Cycle Steam Dynamic Air Removal (Prevacuum) Temperature 132°C (270°F) Exposure Time* Dry Time 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. IFU-007 Rev F Page 2 of 6 Instructions for Use (IFU) Lab Analog and Coating Mandrel 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. IFU-007 Rev F Page 3 of 6 Instructions for Use (IFU) Lab Analog and Coating Mandrel 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-pack with 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-pack with 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-pack with 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-pack with Drill kit, Paltop KDIH-SFA10PKDK PT-007 +D990KDIH-SFA10PKDK0 Premium Starter Kit, BioHorizons BHHD-PSK SFT-003/SFT-008 +D990BHHD-PSK0 Starter Kit, BioHorizons BHHD-SK SFT-003 +D990BHHD-SK0 Recharge Kit w/ Tall Spare Parts, BioHorizons BHHD-RK SFT-003 +D990BHHD-RK0 Recharge Kit w/ POC, BioHorizons BHHD-RKPOC SFT-003 +D990BHHD-RKPOC0 Separable Fastener Assembly 10-pack with Drill kit, BioHorizons BHHDSFA10PKDK 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 IFU-007 Rev F Page 4 of 6 Instructions for Use (IFU) Lab Analog and Coating Mandrel Separable Fastener Assembly 10PK - Drill Kit Included, Low Profile Lab Analog 10PK, ZimVie Coating Mandrel 10PK, ZimVie Premium Starter Kit, Omnibut Recharge Kit w/ Tall Spare Parts, Omnibut Recharge Kit w/ POC, Omnibut Separable Fastener Assembly 10-pack with Drill kit, Omnibut Lab Analog 10PK, Omnibut Coating Mandrel 10PK, Omnibut Coating Mandrel 6PK, Omnibut ZVLP-SFA10PKDK ZV-LA10PK ZV-CM10PK PSK-OA RK-OA RKPOC-OA SFA10PKDK-OA LA10PK-OA CM10PK-OA CM6PK-OA SFT-003 SFT-003 SFT-008 OA-008/OA-009 OA-008 OA-008 OA-008 OA-008 OA-009 OA-009 +D990ZVLP-SFA10PKDK0 +D990ZV-LA10PK0 +D990ZV-CM10PK0 +D990PSK-OA0 +D990RK-OA0 +D990RKPOC-OA0 +D990SFA10PKDK-OA0 +D990LA10PK0 +D990CM10PK0 +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. IFU-007 Rev F Page 5 of 6 Instructions for Use (IFU) Lab Analog and Coating Mandrel 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 United Kingdom Conformity Assessment Mark European Representative Comes Sterilized Comes Sterilized using Ethylene Oxide Processing Comes Sterilized using Dry Heat Processing Do Not Reuse UK Representative United Kingdom Conformity Assessment Mark with Approved Body Number Non-Sterile Comes Sterilized using Aseptic Processing Comes Sterilized using Irradiation Processing Do Not Resterilize Consult Instructions for Use RX Only Keep Dry For Prescription Use Only Do Not Use if Packaging is Damaged Keep Away from Sunlight Caution, Consult Accompanying Documents IFU-007 Rev F Page 6 of 6