FDA 510(k)

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

K号: K250015 · 2025-01-03

决定日期2025-01-03

产品代码DYH

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决定实质等同

器械摘要

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.

常见问题

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.

列明Ormco Corporation为申报人的其他记录

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