| Primary Device ID | D990SADCK1PK0 |
| NIH Device Record Key | 446c1bae-4b9c-4043-a42a-1f0f40826a2c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Single Arch Dam Conversion Kit 1PK |
| Version Model Number | SADCK1PK |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D990SADCK1PK0 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D990SADCK1PK0]
Moist Heat or Steam Sterilization
[D990SADCK1PK0]
Moist Heat or Steam Sterilization
[D990SADCK1PK0]
Moist Heat or Steam Sterilization
[D990SADCK1PK0]
Moist Heat or Steam Sterilization
[D990SADCK1PK0]
Moist Heat or Steam Sterilization
[D990SADCK1PK0]
Moist Heat or Steam Sterilization
[D990SADCK1PK0]
Moist Heat or Steam Sterilization
[D990SADCK1PK0]
Moist Heat or Steam Sterilization
[D990SADCK1PK0]
Moist Heat or Steam Sterilization
[D990SADCK1PK0]
Moist Heat or Steam Sterilization
[D990SADCK1PK0]
Moist Heat or Steam Sterilization
[D990SADCK1PK0]
Moist Heat or Steam Sterilization
[D990SADCK1PK0]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-07-08 |
| Device Publish Date | 2025-06-30 |
| D990SADCK1PK0 - Single Arch Dam Conversion Kit 1PK | 2025-07-08 |
| D990SADCK1PK0 - Single Arch Dam Conversion Kit 1PK | 2025-07-08 |
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