METAL-LINED TRANSCEND CERAMIC BRACKET— 510(k) K944286

Name: FDA 510(k) clearance K944286
Creator: U.S. Food and Drug Administration
Published: 1994-11-29

Substantially Equivalent

Unitek Corp.

FDA 510(k) clearance K944286 for METAL-LINED TRANSCEND CERAMIC BRACKET, Substantially Equivalent on 1994-11-29. Applicant: Unitek Corp.. Device class: 2.

Clearance details

Applicant: Unitek Corp.
Product code: Code DYW
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 1994-09-02
Decision date: 1994-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monrovia, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYW

view all

K252760 — Carriere® Motion Pro® Clear Bite Corrector2025-11-27
K251196 — Composite Orthodontic Brackets and Buttons2025-04-21
K201940 — Braces on Demand Bracket2020-12-03
K182338 — Blue Sky Bio Computerized Orthodontic Bracket System2018-11-09
K180718 — ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES2018-10-30

More clearances from Unitek Corp.

view all

K933501 — ALASTIK1994-04-28
K940165 — ALASTIK1994-03-07
K923999 — ALASTIK NS1993-06-24
K924645 — TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS1992-11-25
K924295 — DEBRACKETING INSTRUMENT1992-11-23

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