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FDA 510(k)

PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION

K-Number: K081291 · 2008-05-22

ApplicantDentsply Interntional
Decision Date2008-05-22
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Interntional. It received FDA 510(k) clearance on 2008-05-22 under 510(k) number K081291. 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 PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION?

PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION is a medical device that received FDA 510(k) clearance on 2008-05-22. The listed applicant is Dentsply Interntional. The 510(k) number is K081291.

When did PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION receive FDA 510(k) clearance?

PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION received FDA 510(k) clearance on 2008-05-22, under 510(k) number K081291.

Who is the listed applicant for PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION?

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

What is the FDA product code for PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION?

The FDA product code for PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION is DYH.

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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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