ArchForm Orthodontic Software System— 510(k) K213916

Name: FDA 510(k) clearance K213916
Creator: U.S. Food and Drug Administration
Published: 2021-12-16

Substantially Equivalent

Archform, Inc.

FDA 510(k) clearance K213916 for ArchForm Orthodontic Software System, Substantially Equivalent on 2021-12-16. Applicant: Archform, Inc.. Device class: 2.

Clearance details

Applicant: Archform, Inc.
Product code: Code PNN
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2021-12-15
Decision date: 2021-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bakersfield, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.