| Primary Device ID | 00850007728144 |
| NIH Device Record Key | f82689ca-12c7-4ee4-843d-2f63cddf57ca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACCESS DENTAL LAB |
| Version Model Number | 100-0365 |
| Company DUNS | 054012763 |
| Company Name | ACCESS DENTAL LAB, LLC |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850007728144 [Primary] |
| NXC | Aligner, Sequential |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-08-12 |
| Device Publish Date | 2019-08-02 |
| 00850007728182 | Power toothbrush replacement head refill 2 pack |
| 00850007728144 | NIGHTTIME CLEAR ALIGNER REPLACEMENT ALIGNERS |
| 00850007728137 | NIGHTTIME CLEAR ALIGNER - REFINEMENT CORRECTIONS |
| 00850007728120 | NIGHTTIME CLEAR ALIGNERS-MIDCOURSE CORRECTIONS |
| 00850007728113 | NIGHTTIME CLEAR ALIGNERS-SEQUENTIAL ALIGNERS |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ACCESS DENTAL LAB 88017945 not registered Live/Pending |
ACCESS DENTAL LAB, LLC 2018-06-27 |