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FDA 510(k)

BracePaste Band and Build LC

K-Number: K202276 · 2020-08-14

ApplicantAmerican Orthodontics
Decision Date2020-08-14
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BracePaste Band and Build LC is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 2020-08-14 under 510(k) number K202276. 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 BracePaste Band and Build LC?

BracePaste Band and Build LC is a medical device that received FDA 510(k) clearance on 2020-08-14. The listed applicant is American Orthodontics. The 510(k) number is K202276.

When did BracePaste Band and Build LC receive FDA 510(k) clearance?

BracePaste Band and Build LC received FDA 510(k) clearance on 2020-08-14, under 510(k) number K202276.

Who is the listed applicant for BracePaste Band and Build LC?

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 BracePaste Band and Build LC?

The FDA product code for BracePaste Band and Build LC is DYH.

Other records listing American Orthodontics 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.

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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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