CLARITY MODIFIED CERAMIC BRACKETS— 510(k) K062305

Substantially Equivalent

3M Unitek

FDA 510(k) clearance K062305 for CLARITY MODIFIED CERAMIC BRACKETS, Substantially Equivalent on 2006-10-18. Applicant: 3M Unitek. Device class: 2.

Clearance details

Applicant: 3M Unitek
Product code: Code NJM
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2006-08-08
Decision date: 2006-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monrovia, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NJM

K232827 — LightForce Orthodontic System2023-09-14
K232011 — Cleo2023-07-07
K231635 — A-Line Advanced2023-06-06
K230225 — DynaFlex Clear Brackets & Buttons2023-06-05
K222847 — Ceramic Brackets Orthometric2023-05-04

More clearances from 3M Unitek

K100536 — TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE2010-07-27
K073697 — TRANSBOND SUPREME ADHESIVE2008-02-15
K020394 — APC PLUS ADHESIVE2002-04-12
K014142 — UNITE BONDING ADHESIVE2002-02-28
K950514 — TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT1995-03-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.