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 |