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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 a medical device manufactured by American Orthodontics. It received FDA 510(k) clearance on 2016-10-14 under approval 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. It is manufactured by American Orthodontics. The 510(k) number is K160782.

When was BracePaste Adhesive approved by the FDA?

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

What company makes BracePaste Adhesive?

BracePaste Adhesive is manufactured by American Orthodontics.

What is the FDA product code for BracePaste Adhesive?

The FDA product code for BracePaste Adhesive is DYH.

Other Devices by American Orthodontics

K181910BracePaste MTP Light Cure Primer K172953Acid Etchant K202276BracePaste Band and Build LC K232011Cleo

Related Devices (Code: DYH)

K161684Quantum LBReliance Orthodontic Products, Inc. K173020OBA-MCP, Orthodontic Bracket Adhesive with MCPPulpdent Corporation K183147BrackFixVoco GmbH K192682Orthocem, Ortho BiteDentscare Ltda K202276BracePaste Band and Build LCAmerican Orthodontics K193388GlassLok Kits, GlassLok Powder, GlassLok LiquidReliance Orthodontic Products, Inc.

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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