Data / Medical devices / United States / Archform, Inc.

Archform, Inc.: FDA-registered device maker in Santa Clara, CA, United States, 2 510(k) clearances

Name: Archform, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Archform, Inc. is registered with the FDA (registration 3018126402) in Santa Clara, CA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 16, 2021. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Archform, Inc.

FDA registration number: 3018126402
Address: 2255 Martin Ave Ste H, Santa Clara, CA, United States, 95050
Owner or operator: Archform Inc. (10047382)
Roles: Manufacturer
First device listed: July 14, 2016
Registered through: 2026
Brand names listed: ArchForm Orthodontic Software System, Archform Retainer, Form Aligners

Devices it lists

Device	Product code	Class	Role	Source
Aligner, Sequential	NXC	2	Manufacturer	accessdata.fda.gov
Maintainer, Space Preformed, Orthodontic	DYT	1	Manufacturer	accessdata.fda.gov
Orthodontic Software	PNN	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 16, 2021	K213916	ArchForm Orthodontic Software System	PNN	Substantially Equivalent	Archform, Inc.	accessdata.fda.gov
March 11, 2016	K151965	Dentti System	NXC	Substantially Equivalent	Martz, Inc.	accessdata.fda.gov

Compare with other makers

Updated December 16, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.