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FDA 510(k)

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

K-Number: K250015 · 2025-01-03

ApplicantOrmco Corporation
Decision Date2025-01-03
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corporation. It received FDA 510(k) clearance on 2025-01-03 under 510(k) 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. The listed applicant is Ormco Corporation. The 510(k) number is K250015.

When did Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive receive FDA 510(k) clearance?

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

Who is the listed applicant for Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive?

The FDA 510(k) record lists Ormco Corporation as the applicant. This does not by itself establish the device manufacturer.

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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NCT07291830A Novel Remineralizing Self-Etch Primer for Orthodontic Bracket BondingNOT_YET_RECRUITING

Other records listing Ormco Corporation as applicant

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Related Devices (Code: DYH)

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K261129OrthoFitSpident Co., Ltd.K261840BracePaste Prime PlusAmerican OrthodonticsK242537BracePaste Fluoride SealantAmerican Orthodontics Corp.K2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic ProductsK231817AlignerFlow LCVoco GmbHK214054TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520Tp Orthodontics, Inc.

Official Source

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