510(k) Report

FDA product code · Dental

Accessories, Implant, Dental, Endosseous

NDPClass I21 CFR 872.3980510(k) exempt4 decisions since 200731 recalls

FDA lists NDP 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. 4 FDA decisions since 2007. 31 recalls name this code, 0 of them Class I. The most-cited predicate is K170849, named by 2 later devices.

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 NDP 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 · NDP

1in 2020

2007: 12017: 12019: 12020: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NDP

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

Recalls per year · NDP

6in 2021

2008: 12009: 12010: 12012: 12013: 12014: 12015: 52016: 22017: 52018: 42021: 6
2007high 6 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NDP

389in 2025

2007: 12008: 22010: 122011: 252012: 102013: 22014: 412015: 1032016: 962017: 2402018: 2782019: 2622020: 1832021: 2372022: 1882023: 2122024: 2242025: 389
2007high 389 (2025) · low 0 (2009)2025

MAUDE reports naming product code NDP, 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—01
20080—12
20090—10
20100—112
20110—025
20120—110
20130—12
20140—141
20150—5103
20160—296
20171—5240
20180—4278
20191—0262
20201—0183
20210—6237
20220—0188
20230—0212
20240—0224
20250—0389
20260—0—
FIG. 1 — NDP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NDP? 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

Related product codes

Other codes under 21 CFR 872.3980.