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FDA 510(k)

ORTHODONTIC POLYMER COMPOSITE BRACKET

K-Number: K053055 · 2005-12-22

ApplicantGestenco International AB
Decision Date2005-12-22
Product CodeDYW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONTIC POLYMER COMPOSITE BRACKET is the device name listed in this FDA 510(k) record. The listed applicant is Gestenco International AB. It received FDA 510(k) clearance on 2005-12-22 under 510(k) number K053055. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHODONTIC POLYMER COMPOSITE BRACKET?

ORTHODONTIC POLYMER COMPOSITE BRACKET is a medical device that received FDA 510(k) clearance on 2005-12-22. The listed applicant is Gestenco International AB. The 510(k) number is K053055.

When did ORTHODONTIC POLYMER COMPOSITE BRACKET receive FDA 510(k) clearance?

ORTHODONTIC POLYMER COMPOSITE BRACKET received FDA 510(k) clearance on 2005-12-22, under 510(k) number K053055.

Who is the listed applicant for ORTHODONTIC POLYMER COMPOSITE BRACKET?

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

What is the FDA product code for ORTHODONTIC POLYMER COMPOSITE BRACKET?

The FDA product code for ORTHODONTIC POLYMER COMPOSITE BRACKET is DYW.

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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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