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FDA 510(k)

PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM

K-Number: K061252 · 2007-02-12

ApplicantPrimus Consulting
Decision Date2007-02-12
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Primus Consulting. It received FDA 510(k) clearance on 2007-02-12 under 510(k) number K061252. 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?

PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM is a medical device that received FDA 510(k) clearance on 2007-02-12. The listed applicant is Primus Consulting. The 510(k) number is K061252.

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

PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM received FDA 510(k) clearance on 2007-02-12, under 510(k) number K061252.

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

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

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

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

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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.

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