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 |