TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520— 510(k) K214054

Name: FDA 510(k) clearance K214054
Creator: U.S. Food and Drug Administration
Published: 2022-10-14

Substantially Equivalent

Tp Orthodontics, Inc.

FDA 510(k) clearance K214054 for TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520, Substantially Equivalent on 2022-10-14. Applicant: Tp Orthodontics, Inc.. Device class: 2.

Clearance details

Applicant: Tp Orthodontics, Inc.
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 2021-12-27
Decision date: 2022-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Porte, IN, US

Download summary PDF View on FDA.gov ↗

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