| Primary Device ID | D7641000053341 |
| NIH Device Record Key | fcd69502-2ea1-4e7f-a32a-6590d77ef8ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AimRight |
| Version Model Number | 100005334 |
| 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 |
| Phone | 800.659.5977 |
| imagingsupportus@dentsplysirona.com | |
| Phone | 800.659.5977 |
| imagingsupportus@dentsplysirona.com | |
| Phone | 800.659.5977 |
| imagingsupportus@dentsplysirona.com | |
| Phone | 800.659.5977 |
| imagingsupportus@dentsplysirona.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D7641000053341 [Primary] |
| EHA | Aligner, Beam, 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 |
| D7641000053451 | AIMRIGHT ADHESIVE HOLDERS SAMPLER |
| D7641000053341 | AimRight Aiming Ring, Red 1 PC |
| D7641000053331 | AimRight Sensor Holder, ANT-Blue S2 2PC |
| D7641000053321 | AimRight Sensor Holder, ANT-Blue S1 2PC |
| D7641000053311 | AimRight Sensor Holder, BW-Red S2 2PC |
| D7641000053301 | AimRight Sensor Holder, BW-Red S1 2PC |
| D7641000053251 | AimRight Sensor Holder, PA-Yel. S2 4pc |
| D7641000053241 | AimRight Sensor Holder, PA-Yel. S1 4pc |