FDA product code · Dental

Bracket, Plastic, Orthodontic, Reprocessed

Name: FDA decisions, review times, recalls and adverse event reports for product code NLC
Creator: 510(k) Report

NLCClass II21 CFR 872.5470510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

same as DYW except it is being reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

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 NLC 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.

FIG. 1 — NLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NLC? 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 872.5470.

PNN Orthodontic Software OYH Orthodontic Vibratory Accessory DYW Bracket, Plastic, Orthodontic PLH Orthodontic Led Accessory NJM Bracket, Ceramic, Orthodontic NXC Aligner, Sequential