ArchForm Orthodontic Software System

Orthodontic Software

ArchForm, Inc

The following data is part of a premarket notification filed by Archform, Inc with the FDA for Archform Orthodontic Software System.

Pre-market Notification Details

Device IDK213916
510k NumberK213916
Device Name:ArchForm Orthodontic Software System
ClassificationOrthodontic Software
Applicant ArchForm, Inc 8421 Blue Heron Drive Bakersfield,  CA  93312
ContactAndrew S. Martz
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodePNN  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-12-15
Decision Date2021-12-16

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