Therapeutic devices · 21 CFR 872 Subpart F

Reprocessed Orthodontic Plastic Bracket

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).

FDA codeNLCClass221 CFR872.5470Pathway510(k)

Companies listing it: 00 makers
Brands and models: 0
510(k) clearances: 00 in five years
FDA name: Bracket, Plastic, Orthodontic, Reprocessed

Official records: FDA product classification for NLC · 21 CFR 872.5470.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026