Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BracePaste Adhesive

K-Number: K160782 · 2016-10-14

ApplicantAmerican Orthodontics
Decision Date2016-10-14
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BracePaste Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K160782. 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 Adhesive?

BracePaste Adhesive is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is American Orthodontics. The 510(k) number is K160782.

When did BracePaste Adhesive receive FDA 510(k) clearance?

BracePaste Adhesive received FDA 510(k) clearance on 2016-10-14, under 510(k) number K160782.

Who is the listed applicant for BracePaste Adhesive?

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 Adhesive?

The FDA product code for BracePaste Adhesive 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.

K261840BracePaste Prime PlusK242537BracePaste Fluoride SealantK232011CleoK202276BracePaste Band and Build LCK181910BracePaste MTP Light Cure PrimerK172953Acid Etchant

View all 7 devices →

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.

↑