Archform Orthodontic Software 2

GUDID 00860012168521

Archform Inc.

CAD/CAM software
Primary Device ID00860012168521
NIH Device Record Key49c7bfe8-46d5-4122-9eed-1276c41068b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameArchform Orthodontic Software
Version Model NumberVarious
Catalog Number2
Company DUNS119306995
Company NameArchform Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860012168521 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-30
Device Publish Date2025-07-22

Devices Manufactured by Archform Inc.

00860012168514 - Archform2025-07-30 Archform Aligners and Retainers
00860012168521 - Archform Orthodontic Software2025-07-30
00860012168521 - Archform Orthodontic Software2025-07-30

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