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FDA 510(k)

PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II

K-Number: K093221 · 2009-10-30

ApplicantDentsply Intl., Inc.
Decision Date2009-10-30
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl., Inc.. It received FDA 510(k) clearance on 2009-10-30 under 510(k) number K093221. 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 II?

PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II is a medical device that received FDA 510(k) clearance on 2009-10-30. The listed applicant is Dentsply Intl., Inc.. The 510(k) number is K093221.

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

PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II received FDA 510(k) clearance on 2009-10-30, under 510(k) number K093221.

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

The FDA 510(k) record lists Dentsply Intl., Inc. 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 II?

The FDA product code for PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II 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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