| Primary Device ID | D990PTB1PKOA0 |
| NIH Device Record Key | 334e576e-380c-47ba-9c48-b3d15ae7b39b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pre-Coated TiBase 1PK, Omnibut |
| Version Model Number | PTB1PK-OA |
| Company DUNS | 010613514 |
| Company Name | Smart Denture Conversions, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Conditional |
| 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 | D990PTB1PKOA0 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| 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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| D99023NANPOA0 - Omnibut, Nobel NP | 2025-05-27 |
| D99023NARPOA0 - Omnibut, Nobel RP | 2025-05-27 |
| D99023NEOGMOA0 - Omnibut, Neodent GM | 2025-05-27 |
| D99023ZIH35OA0 - Omnibut, Zimmer Internal Hex 3.5 | 2025-05-27 |
| D99023ZIH45OA0 - Omnibut, Zimmer Internal Hex 4.5 | 2025-05-27 |
| D99023ZIH57OA0 - Omnibut, Zimmer Internal Hex 5.7 | 2025-05-27 |
| D990CC1PK0 - Comfort Cap 1PK | 2025-05-27 |