| Primary Device ID | D764B10742011 |
| NIH Device Record Key | 214370e8-7a7c-48b2-ae4c-ebb5d1c872e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AimRight Holder |
| Version Model Number | B1074201 |
| Company DUNS | 078613913 |
| Company Name | SIRONA DENTAL, 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D764B10742011 [Primary] |
| EGZ | Holder, Film, X-Ray |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-15 |
| Device Publish Date | 2022-12-07 |
| D764B10742051 | AimRight S2 LL/UR Posterior Periapical Grip Holder |
| D764B10742041 | AimRight S2 UL/LR Posterior Periapical Grip Holder |
| D764B10742031 | AimRight S2 Anterior Periapical Grip Holder |
| D764B10742021 | AimRight S2 Vertical Bitewing Grip Holder |
| D764B10742011 | AimRight S2 Horizontal Bitewing Grip Holder |
| D764B10741051 | AimRight S1 LL/UR Posterior Periapical Grip Holder |
| D764B10741041 | AimRight S1 UL/LR Posterior Periapical Grip Holder |
| D764B10741031 | AimRight S1 Anterior Periapical Grip Holder |
| D764B10741021 | AimRight S1 Vertical Bitewing Grip Holder |
| D764B10741011 | AimRight S1 Horizontal Bitewing Grip Holder |
| D764B10740501 | AimRight Grip Aiming Ring |