The following data is part of a premarket notification filed by Precision Align Llc. with the FDA for Precision Align.
| Device ID | K212772 |
| 510k Number | K212772 |
| Device Name: | Precision Align |
| Classification | Aligner, Sequential |
| Applicant | Precision Align LLC. 1825 NE 45th Street Suite A Fort Lauderdale, FL 33308 |
| Contact | Chris Freeman |
| Correspondent | Na Zhang evo820, LLC 1 Bay Street Rancho Mission Viejo, CA 92694 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-31 |
| Decision Date | 2022-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860010675700 | K212772 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PRECISION ALIGN 97257422 not registered Live/Pending |
Precision Align, LLC 2022-02-08 |
![]() PRECISION ALIGN 90660737 not registered Live/Pending |
Precision Align, LLC 2021-04-21 |