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FDA 510(k)

CHALLENGE ORTHODONTIC BONDING ADHESIVE

K-Number: K863709 · 1987-01-21

ApplicantOrmco Corp.
Decision Date1987-01-21
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CHALLENGE ORTHODONTIC BONDING ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corp.. It received FDA 510(k) clearance on 1987-01-21 under 510(k) number K863709. 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 CHALLENGE ORTHODONTIC BONDING ADHESIVE?

CHALLENGE ORTHODONTIC BONDING ADHESIVE is a medical device that received FDA 510(k) clearance on 1987-01-21. The listed applicant is Ormco Corp.. The 510(k) number is K863709.

When did CHALLENGE ORTHODONTIC BONDING ADHESIVE receive FDA 510(k) clearance?

CHALLENGE ORTHODONTIC BONDING ADHESIVE received FDA 510(k) clearance on 1987-01-21, under 510(k) number K863709.

Who is the listed applicant for CHALLENGE ORTHODONTIC BONDING ADHESIVE?

The FDA 510(k) record lists Ormco Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHALLENGE ORTHODONTIC BONDING ADHESIVE?

The FDA product code for CHALLENGE ORTHODONTIC BONDING ADHESIVE is DYH.

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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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