| Primary Device ID | D990DSF1PKM20 |
| NIH Device Record Key | 82d7d0f0-ec3d-403d-875a-1b770768fa79 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Direct Separable Fastener 10PK, M2 |
| Version Model Number | DSF1PK-M2 |
| 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 | D990DSF1PKM20 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D990DSF1PKM20]
Moist Heat or Steam Sterilization
[D990DSF1PKM20]
Moist Heat or Steam Sterilization
[D990DSF1PKM20]
Moist Heat or Steam Sterilization
[D990DSF1PKM20]
Moist Heat or Steam Sterilization
[D990DSF1PKM20]
Moist Heat or Steam Sterilization
[D990DSF1PKM20]
Moist Heat or Steam Sterilization
[D990DSF1PKM20]
Moist Heat or Steam Sterilization
[D990DSF1PKM20]
Moist Heat or Steam Sterilization
[D990DSF1PKM20]
Moist Heat or Steam Sterilization
[D990DSF1PKM20]
Moist Heat or Steam Sterilization
[D990DSF1PKM20]
Moist Heat or Steam Sterilization
[D990DSF1PKM20]
Moist Heat or Steam Sterilization
[D990DSF1PKM20]
Moist Heat or Steam Sterilization
[D990DSF1PKM20]
Moist Heat or Steam Sterilization
[D990DSF1PKM20]
Moist Heat or Steam Sterilization
[D990DSF1PKM20]
Moist Heat or Steam Sterilization
[D990DSF1PKM20]
Moist Heat or Steam Sterilization
[D990DSF1PKM20]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-27 |
| Device Publish Date | 2025-05-19 |
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