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FDA 510(k)

RIGHT-ON ADHESIVE BOUDING SYSTEM

K-Number: K952643 · 1995-07-11

ApplicantTp Orthodontics, Inc.
Decision Date1995-07-11
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RIGHT-ON ADHESIVE BOUDING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tp Orthodontics, Inc.. It received FDA 510(k) clearance on 1995-07-11 under 510(k) number K952643. 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 RIGHT-ON ADHESIVE BOUDING SYSTEM?

RIGHT-ON ADHESIVE BOUDING SYSTEM is a medical device that received FDA 510(k) clearance on 1995-07-11. The listed applicant is Tp Orthodontics, Inc.. The 510(k) number is K952643.

When did RIGHT-ON ADHESIVE BOUDING SYSTEM receive FDA 510(k) clearance?

RIGHT-ON ADHESIVE BOUDING SYSTEM received FDA 510(k) clearance on 1995-07-11, under 510(k) number K952643.

Who is the listed applicant for RIGHT-ON ADHESIVE BOUDING SYSTEM?

The FDA 510(k) record lists Tp Orthodontics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIGHT-ON ADHESIVE BOUDING SYSTEM?

The FDA product code for RIGHT-ON ADHESIVE BOUDING SYSTEM is DYH.

Related Clinical Trials

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Other records listing Tp Orthodontics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K214054TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520K193385TP Orthodontics Clear Aligner SystemK111234CLICK-ITK950992CERAMAFLEX BRACKET SYSTEM

Related Devices (Code: DYH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261129OrthoFitSpident Co., Ltd.K261840BracePaste Prime PlusAmerican OrthodonticsK250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco CorporationK242537BracePaste Fluoride SealantAmerican Orthodontics Corp.K2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic ProductsK231817AlignerFlow LCVoco GmbH

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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