510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K122065Substantially Equivalent

Digital Impression System for Orthodontic Use

Ormco Corp., Orange CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122065 is the FDA 510(k) clearance record for DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE, a class II device, cleared for Ormco Corp. on under FDA product code NOF (System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations). FDA's definition for product code NOF reads: "An optical impression system for cad/cam of dental restorations is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer aided design...". FDA records list 12 510(k) clearances for Ormco Corp., from to . As of , FDA records show no recalls naming K122065.

Clearance record

Decision date
Received
(210 days to decision)
Product code
NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Regulation
21 CFR 872.3661
Device class
Class II
Review panel
Dental
Applicant
Ormco Corp. 1717 W. Collins Ave., Orange CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NOF

Trailing 12 months

FDA records hold no clearances under product code NOF in the trailing twelve months.

FDA records show no clearances under product code NOF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NOF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260