510(k) Report

FDA product code · Dental

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

NOFClass II21 CFR 872.3661510(k) exempt5 decisions since 20070 recalls

FDA lists NOF as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 872.9 applies, such as a new intended use or a different fundamental technology. 5 FDA decisions since 2007. No recall names this code. The most-cited predicate is K081961, named by 2 later devices.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, dental panel

Twenty years of NOF at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NOF

1in 2014

2007: 12008: 12012: 12013: 12014: 1
2007high 1 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NOF

Too few NOF 510(k)s in any year since 2007 to give a median.

Recalls per year · NOF

No recall names NOF since 2007.

Adverse event reports per year · NOF

3in 2025

2008: 12011: 52012: 12013: 12014: 22015: 32016: 102017: 42021: 22023: 22024: 22025: 3
2007high 10 (2016) · low 0 (2007)2025

MAUDE reports naming product code NOF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20081—01
20090—00
20100—00
20110—05
20121—01
20131—01
20141—02
20150—03
20160—010
20170—04
20180—00
20190—00
20200—00
20210—02
20220—00
20230—02
20240—02
20250—03
20260—0—
FIG. 1 — NOF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NOF? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do NOF devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K0819613M Unitek Lava Chairside Oral ScannerBrontes Technologies · 20082cite it
  • K0731993M Espe Lava Chairside Oral ScannerBrontes Technologies · 20072cite it
  • K122065Digital Impression System for Orthodontic UseOrmco Corp. · 20131cites it

Which NOF devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K141611Lythos Digital Impression SystemOrmco Corp. · 20144generations
  • K122065Digital Impression System for Orthodontic UseOrmco Corp. · 20133generations
  • K1224673M True Definition Scanner3M Company · 20123generations
  • K0819613M Unitek Lava Chairside Oral ScannerBrontes Technologies · 20082generations
  • K0731993M Espe Lava Chairside Oral ScannerBrontes Technologies · 20071generation

What has FDA decided in NOF lately?

  • K141611Lythos Digital Impression SystemOrmco Corp. · 2014
  • K122065Digital Impression System for Orthodontic UseOrmco Corp. · 2013
  • K1224673M True Definition Scanner3M Company · 2012
  • K0819613M Unitek Lava Chairside Oral ScannerBrontes Technologies · 2008
  • K0731993M Espe Lava Chairside Oral ScannerBrontes Technologies · 2007

All 5 NOF decisions →

Related product codes

Other codes under 21 CFR 872.3661.

KZN Scanner, ColorQJK Intraoral Camera