CERAMAFLEX BRACKET SYSTEM— 510(k) K950992

Name: FDA 510(k) clearance K950992
Creator: U.S. Food and Drug Administration
Published: 1995-05-03

Substantially Equivalent

Tp Orthodontics, Inc.

FDA 510(k) clearance K950992 for CERAMAFLEX BRACKET SYSTEM, Substantially Equivalent on 1995-05-03. Applicant: Tp Orthodontics, Inc.. Device class: 2.

Clearance details

Applicant: Tp Orthodontics, Inc.
Product code: Code NJM
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 1995-03-03
Decision date: 1995-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Porte, IN, US

Download summary PDF View on FDA.gov ↗

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K222847 — Ceramic Brackets Orthometric2023-05-04

More clearances from Tp Orthodontics, Inc.

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K214054 — TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant2085202022-10-14
K193385 — TP Orthodontics Clear Aligner System2020-11-12
K111234 — CLICK-IT2011-05-13
K952643 — RIGHT-ON ADHESIVE BOUDING SYSTEM1995-07-11

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