CP BRACKET SYSTEM— 510(k) K052370

Substantially Equivalent

Dentsply International

FDA 510(k) clearance K052370 for CP BRACKET SYSTEM, Substantially Equivalent on 2005-11-01. Applicant: Dentsply International. Device class: 2.

Clearance details

Applicant: Dentsply International
Product code: Code DYW
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2005-08-30
Decision date: 2005-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYW

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 Dentsply International

K122268 — ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS2012-12-11
K061580 — ECLIPSE WAX REMOVER2006-07-28
K060837 — IN-OVATION C2006-04-10
K053368 — INTERPROXIMAL REDUCTION SYSTEM2006-03-29
K052097 — CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE2005-08-12

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