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FDA 510(k)

TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520

K-Number: K214054 · 2022-10-14

ApplicantTp Orthodontics, Inc.
Decision Date2022-10-14
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 is a medical device manufactured by Tp Orthodontics, Inc.. It received FDA 510(k) clearance on 2022-10-14 under approval number K214054. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520?

TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 is a medical device that received FDA 510(k) clearance on 2022-10-14. It is manufactured by Tp Orthodontics, Inc.. The 510(k) number is K214054.

When was TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 approved by the FDA?

TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 received FDA 510(k) clearance on 2022-10-14, under approval number K214054.

What company makes TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520?

TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 is manufactured by Tp Orthodontics, Inc..

What is the FDA product code for TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520?

The FDA product code for TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 is DYH.

Related Clinical Trials

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Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022)

Other Devices by Tp Orthodontics, Inc.

K193385TP Orthodontics Clear Aligner System

Related Devices (Code: DYH)

K160782BracePaste AdhesiveAmerican Orthodontics K161684Quantum LBReliance Orthodontic Products, Inc. K173020OBA-MCP, Orthodontic Bracket Adhesive with MCPPulpdent Corporation K183147BrackFixVoco GmbH K192682Orthocem, Ortho BiteDentscare Ltda K202276BracePaste Band and Build LCAmerican Orthodontics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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