| Primary Device ID | 00652221236487 |
| NIH Device Record Key | e0af1f0c-20b3-4419-a1ba-07ef837eda32 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clarity™ Aligners |
| Version Model Number | 358-443 |
| Catalog Number | 358-443 |
| Company DUNS | 008256356 |
| Company Name | 3M UNITEK CORPORATION |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)423-4588 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(800)423-4588 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(800)423-4588 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(800)423-4588 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(800)423-4588 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(800)423-4588 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(800)423-4588 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(800)423-4588 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(800)423-4588 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(800)423-4588 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(800)423-4588 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(800)423-4588 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(800)423-4588 |
| 3Mhealthcarecompliance@mmm.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00652221236487 [Primary] |
| NXC | Aligner, sequential |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-12-20 |
| 00652221236609 | 3M™ Clarity™ Aligner Systems |
| 00652221236593 | 3M™ Clarity™ Retainers |
| 00652221236586 | 3M™ Clarity™ Aligner Attachment Templates |
| 00652221236579 | 3M™ Clarity™ Aligners |
| 00652221236500 | 3M™ Retainer - Single Arch |
| 00652221236494 | 3M™ Retainer - Dual Arch |
| 00652221236487 | 3M™ Clarity™ Aligner Replacement |
| 00652221236470 | 3M™ Clarity™ Aligner - Single Arch |
| 00652221236463 | 3M™ Clarity™ Aligner - Dual Arch |
| 00652221236456 | 3M™ Clarity™ Aligner Attachment Template - Single Arch |
| 00652221236449 | 3M™ Clarity™ Aligner Attachment Template - Dual Arch |
| 00652221236432 | 3M™ Clarity™ Aligner Replacement - Lost/Damaged |
| 00652221236425 | 3M™ Clarity™ Aligner Refinement - Single Arch |
| 00652221236418 | 3M™ Clarity™ Aligner Refinement - Dual Arch |