| Primary Device ID | 00810126381712 |
| NIH Device Record Key | 1b18ccb3-383c-4449-a416-8ba32071ce19 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Splint - Anterior Deprogrammer |
| Version Model Number | 1712 |
| Company DUNS | 251537143 |
| Company Name | Digital Dental Laboratories, Inc |
| 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 | false |
| 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 |
|---|---|
| GS1 | 00810126381712 [Primary] |
| DYT | Maintainer, Space Preformed, Orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-05 |
| Device Publish Date | 2026-02-25 |
| 00810126381118 - Nance - Hor Rem | 2026-03-06 |
| 00810126380159 - Set Full Denture | 2026-03-05 |
| 00810126380166 - Finish Full Denture | 2026-03-05 |
| 00810126380173 - Finish Denture - 1-3 Teeth | 2026-03-05 |
| 00810126380180 - Finish Denture - 4-7 Teeth | 2026-03-05 |
| 00810126380197 - Finish Denture - 8+ teeth | 2026-03-05 |
| 00810126380203 - Flipper - 1 to 2 teeth | 2026-03-05 |
| 00810126380210 - Flipper - 3+ teeth | 2026-03-05 |