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

System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

21 CFR 872.3661 / Dental
FDA source (opens on fda.gov)

NOF is the FDA product code for System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations, a class II device type, regulated under 21 CFR 872.3661. FDA's definition for this code 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 and manufacturing of dental restorative prosthetic devices. Such systems may...". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
NOF
Device name
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
FDA definition
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 and manufacturing of dental restorative prosthetic devices. Such systems may consist of a camera, scanner, or equivalent type of sensor and a computer with software.
Regulation
21 CFR 872.3661
Device class
Class II
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
1

Clearances, product code NOF

By decision year
5 clearances under product code NOF with a decision year between 2007 and 2014, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NOF by decision year
YearClearances
20071
20081
20121
20131
20141

Applicants with the most clearances

Product code NOF
Applicants holding the most 510(k) clearances under product code NOF
ApplicantClearances
Brontes Technologies2
Ormco Corp.2
3M Company1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 144 companies shown, in name order