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FDA 510(k)

NO-MIX 30 ORTHODONTIC BONDING SYSTEMS

K-Number: K893037 · 1989-06-12

ApplicantAmerican Orthodontics
Decision Date1989-06-12
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NO-MIX 30 ORTHODONTIC BONDING SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 1989-06-12 under 510(k) number K893037. 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 NO-MIX 30 ORTHODONTIC BONDING SYSTEMS?

NO-MIX 30 ORTHODONTIC BONDING SYSTEMS is a medical device that received FDA 510(k) clearance on 1989-06-12. The listed applicant is American Orthodontics. The 510(k) number is K893037.

When did NO-MIX 30 ORTHODONTIC BONDING SYSTEMS receive FDA 510(k) clearance?

NO-MIX 30 ORTHODONTIC BONDING SYSTEMS received FDA 510(k) clearance on 1989-06-12, under 510(k) number K893037.

Who is the listed applicant for NO-MIX 30 ORTHODONTIC BONDING SYSTEMS?

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 NO-MIX 30 ORTHODONTIC BONDING SYSTEMS?

The FDA product code for NO-MIX 30 ORTHODONTIC BONDING SYSTEMS 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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