FDA 510(k)

BracePaste Band and Build LC

K-Number: K202276 · 2020-08-14

Decision Date2020-08-14

Product CodeDYH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

BracePaste Band and Build LC is a medical device manufactured by American Orthodontics. It received FDA 510(k) clearance on 2020-08-14 under approval 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. It is manufactured by American Orthodontics. The 510(k) number is K202276.

When was BracePaste Band and Build LC approved by the FDA?

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

What company makes BracePaste Band and Build LC?

BracePaste Band and Build LC is manufactured by American Orthodontics.

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 Devices by American Orthodontics

K160782BracePaste Adhesive K181910BracePaste MTP Light Cure Primer K172953Acid Etchant K232011Cleo

Related Devices (Code: DYH)

K160782BracePaste AdhesiveAmerican Orthodontics K161684Quantum LBReliance Orthodontic Products, Inc. K173020OBA-MCP, Orthodontic Bracket Adhesive with MCPPulpdent Corporation K183147BrackFixVoco GmbH K192682Orthocem, Ortho BiteDentscare Ltda K193388GlassLok Kits, GlassLok Powder, GlassLok LiquidReliance Orthodontic Products, Inc.

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.