FDA 510(k)

Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive

K-Number: K250015 · 2025-01-03

Decision Date2025-01-03

Product CodeDYH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive is a medical device manufactured by Ormco Corporation. It received FDA 510(k) clearance on 2025-01-03 under approval number K250015. 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 Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive?

Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive is a medical device that received FDA 510(k) clearance on 2025-01-03. It is manufactured by Ormco Corporation. The 510(k) number is K250015.

When was Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive approved by the FDA?

Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive received FDA 510(k) clearance on 2025-01-03, under approval number K250015.

What company makes Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive?

Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive is manufactured by Ormco Corporation.

What is the FDA product code for Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive?

The FDA product code for Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive is DYH.

Related Clinical Trials

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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 K202276BracePaste Band and Build LCAmerican Orthodontics

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.