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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthodontic software
510(k) Number K213916
Device Name ArchForm Orthodontic Software System
Applicant
ArchForm, Inc
8421 Blue Heron Drive
Bakersfield,  CA  93312
Applicant Contact Andrew S. Martz
Correspondent
THIRD PARTY REVIEW GROUP, LLC
25 Independence Blvd
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number872.5470
Classification Product Code
PNN  
Subsequent Product Code
LLZ  
Date Received12/15/2021
Decision Date 12/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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