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FDA 510(k)

ORTHODONTIC CERAMIC BRACKETS

K-Number: K042178 · 2004-08-30

ApplicantDentsply Intl.
Decision Date2004-08-30
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONTIC CERAMIC BRACKETS is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2004-08-30 under 510(k) number K042178. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHODONTIC CERAMIC BRACKETS?

ORTHODONTIC CERAMIC BRACKETS is a medical device that received FDA 510(k) clearance on 2004-08-30. The listed applicant is Dentsply Intl.. The 510(k) number is K042178.

When did ORTHODONTIC CERAMIC BRACKETS receive FDA 510(k) clearance?

ORTHODONTIC CERAMIC BRACKETS received FDA 510(k) clearance on 2004-08-30, under 510(k) number K042178.

Who is the listed applicant for ORTHODONTIC CERAMIC BRACKETS?

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

What is the FDA product code for ORTHODONTIC CERAMIC BRACKETS?

The FDA product code for ORTHODONTIC CERAMIC BRACKETS is NJM.

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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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