| Primary Device ID | D990FZMFTSF10PK0 |
| NIH Device Record Key | f220d49b-aa01-4b85-b637-7473b4e234c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tall Separable Fastener 10PK, 0.05'' Hex |
| Version Model Number | FZMF-TSF10PK |
| Company DUNS | 010613514 |
| Company Name | Smart Denture Conversions, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D990FZMFTSF10PK0 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D990FZMFTSF10PK0]
Moist Heat or Steam Sterilization
[D990FZMFTSF10PK0]
Moist Heat or Steam Sterilization
[D990FZMFTSF10PK0]
Moist Heat or Steam Sterilization
[D990FZMFTSF10PK0]
Moist Heat or Steam Sterilization
[D990FZMFTSF10PK0]
Moist Heat or Steam Sterilization
[D990FZMFTSF10PK0]
Moist Heat or Steam Sterilization
[D990FZMFTSF10PK0]
Moist Heat or Steam Sterilization
[D990FZMFTSF10PK0]
Moist Heat or Steam Sterilization
[D990FZMFTSF10PK0]
Moist Heat or Steam Sterilization
[D990FZMFTSF10PK0]
Moist Heat or Steam Sterilization
[D990FZMFTSF10PK0]
Moist Heat or Steam Sterilization
[D990FZMFTSF10PK0]
Moist Heat or Steam Sterilization
[D990FZMFTSF10PK0]
Moist Heat or Steam Sterilization
[D990FZMFTSF10PK0]
Moist Heat or Steam Sterilization
[D990FZMFTSF10PK0]
Moist Heat or Steam Sterilization
[D990FZMFTSF10PK0]
Moist Heat or Steam Sterilization
[D990FZMFTSF10PK0]
Moist Heat or Steam Sterilization
[D990FZMFTSF10PK0]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-07-14 |
| Device Publish Date | 2022-12-26 |
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| D990CA10PK0 - Cementation Aid 10PK | 2024-11-11 |
| D990CTB10PK0 - Cementable TiBase 10PK | 2024-11-11 |
| D990GSB10PK0 - Gingival Scan Body 10PK | 2024-11-11 |
| D990HSG10PK0 - Horizontal Scan Gauge 10PK | 2024-11-11 |
| D990OTICMU5PK0 - Open Tray Impression Coping Multi-Unit 5PK | 2024-11-11 |