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FDA 510(k)

AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM

K-Number: K893396 · 1989-06-23

ApplicantAmerican Orthodontics
Decision Date1989-06-23
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K893396. 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 AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM?

AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is American Orthodontics. The 510(k) number is K893396.

When did AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM receive FDA 510(k) clearance?

AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM received FDA 510(k) clearance on 1989-06-23, under 510(k) number K893396.

Who is the listed applicant for AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM?

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

What is the FDA product code for AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM?

The FDA product code for AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM is DYH.

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Other records listing American Orthodontics as applicant

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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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