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FDA 510(k)

CRYSTAL-BOND

K-Number: K810241 · 1981-02-12

ApplicantAmerican Ormco
Decision Date1981-02-12
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CRYSTAL-BOND is the device name listed in this FDA 510(k) record. The listed applicant is American Ormco. It received FDA 510(k) clearance on 1981-02-12 under 510(k) number K810241. 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 CRYSTAL-BOND?

CRYSTAL-BOND is a medical device that received FDA 510(k) clearance on 1981-02-12. The listed applicant is American Ormco. The 510(k) number is K810241.

When did CRYSTAL-BOND receive FDA 510(k) clearance?

CRYSTAL-BOND received FDA 510(k) clearance on 1981-02-12, under 510(k) number K810241.

Who is the listed applicant for CRYSTAL-BOND?

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

What is the FDA product code for CRYSTAL-BOND?

The FDA product code for CRYSTAL-BOND is DYH.

Related Clinical Trials

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.

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Other records listing American Ormco 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.

K812300LINGUAL BRACKET

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

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

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