| Primary Device ID | 00852550007196 |
| NIH Device Record Key | a4cc7dcf-2f91-4996-9053-c1c12ade47db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 16 MM ULTRA TOOTH SOLID WIDE IMPLANT |
| Version Model Number | 3916UTW |
| Company DUNS | 017725036 |
| Company Name | Bio-Dent, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Height | 16 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852550007196 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-12-22 |
| 00852550007165 - 8mm ULTRA TOOTH SOLID WIDE IMPLANT | 2018-07-06 |
| 00852550007172 - 10 MM ULTRA TOOTH SOLID WIDE IMPLANT | 2018-07-06 |
| 00852550007189 - 13 MM ULTRA TOOTH SOLID WIDE IMPLANT | 2018-07-06 |
| 00852550007196 - 16 MM ULTRA TOOTH SOLID WIDE IMPLANT | 2018-07-06 |
| 00852550007196 - 16 MM ULTRA TOOTH SOLID WIDE IMPLANT | 2018-07-06 |
| 00852550007202 - 8 MM ULTRA TOOTH IMPLANT | 2018-07-06 |
| 00852550007219 - 10 MM ULTRA TOOTH IMPLANT | 2018-07-06 |
| 00852550007226 - 13 MM ULTRA TOOTH IMPLANT | 2018-07-06 |
| 00852550007233 - 16 MM ULTRA TOOTH IMPLANT | 2018-07-06 |