The following data is part of a premarket notification filed by Archform, Inc with the FDA for Archform Orthodontic Software System.
Device ID | K213916 |
510k Number | K213916 |
Device Name: | ArchForm Orthodontic Software System |
Classification | Orthodontic Software |
Applicant | ArchForm, Inc 8421 Blue Heron Drive Bakersfield, CA 93312 |
Contact | Andrew S. Martz |
Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
Product Code | PNN |
CFR Regulation Number | 872.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2021-12-15 |
Decision Date | 2021-12-16 |