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FDA 510(k)

TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE

K-Number: K100536 · 2010-07-27

Applicant3M Unitek
Decision Date2010-07-27
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is 3M Unitek. It received FDA 510(k) clearance on 2010-07-27 under 510(k) number K100536. 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 TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE?

TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE is a medical device that received FDA 510(k) clearance on 2010-07-27. The listed applicant is 3M Unitek. The 510(k) number is K100536.

When did TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE receive FDA 510(k) clearance?

TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE received FDA 510(k) clearance on 2010-07-27, under 510(k) number K100536.

Who is the listed applicant for TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE?

The FDA 510(k) record lists 3M Unitek as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE?

The FDA product code for TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE is DYH.

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Other records listing 3M Unitek 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.

K073697TRANSBOND SUPREME ADHESIVEK062305CLARITY MODIFIED CERAMIC BRACKETSK020394APC PLUS ADHESIVEK014142UNITE BONDING ADHESIVEK950514TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT

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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