FDA product code NOF: System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
NOF is the FDA product code for system, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations. It is a Class II device, regulated under 21 CFR 872.3661 and reviewed by the Dental panel. FDA has cleared 5 510(k) submissions under NOF, from 3 different applicants. The average 510(k) review took 115 days (median 99). FDA has posted 1 recall for NOF devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
| Device class | Class II |
| Regulation | 21 CFR 872.3661 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NOF clearance
Top NOF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ormco Corp. | 2 | 2014-12-05 |
| Brontes Technologies | 2 | 2008-09-05 |
| 3M Company | 1 | 2012-11-20 |
Most recent NOF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K141611 | Ormco Corp. | LYTHOS DIGITAL IMPRESSION SYSTEM | 2014-12-05 | 172 |
| K122065 | Ormco Corp. | DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE | 2013-02-08 | 210 |
| K122467 | 3M Company | 3M TRUE DEFINITION SCANNER | 2012-11-20 | 99 |
| K081961 | Brontes Technologies | 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER | 2008-09-05 | 58 |
| K073199 | Brontes Technologies | 3M ESPE LAVA CHAIRSIDE ORAL SCANNER | 2007-12-21 | 38 |
Recalls for NOF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-02-15.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code NOF?
NOF is the FDA product code for system, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations. It is a Class II device, regulated under 21 CFR 872.3661 and reviewed by the Dental panel.
What device class is NOF?
Class II, regulation 21 CFR 872.3661. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NOF?
Across 5 cleared submissions the average was 115 days from receipt to decision (median 99).
Which companies have the most NOF clearances?
Ormco Corp. (2); Brontes Technologies (2); 3M Company (1).
Have NOF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-02-15.
Next steps
- Run an FDA pathway report with predicate devices for product code NOF
- Run a recall and safety report across every NOF manufacturer
- Watch product code NOF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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