| Primary Device ID | D807100141101 |
| NIH Device Record Key | 2de66943-44f0-453f-bd8d-b7653329169d |
| Commercial Distribution Discontinuation | 2020-01-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | IN-OVATION® C |
| Version Model Number | 100-141-10 |
| Catalog Number | 100-141-10 |
| Company DUNS | 053475903 |
| Company Name | GAC |
| Device Count | 5 |
| DM Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D807100141100 [Unit of Use] |
| HIBCC | D807100141101 [Primary] |
| NJM | Bracket, ceramic, orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-01-31 |
| Device Publish Date | 2017-06-26 |
| D807100241101 | IN-OVATION® C RT RX 018/UL4&5 -7T0A2DHK |
| D807100141101 | IN-OVATION® C RT RX 018/UR4&5 -7T0A2 HK |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IN-OVATION 78731830 3274398 Live/Registered |
SANTA FE OPERA 2005-10-12 |
![]() IN-OVATION 75515612 2492999 Live/Registered |
DENTSPLY SIRONA INC. 1998-07-08 |