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FDA 510(k)

ALLURE MB CERAMIC BRACKETS

K-Number: K090454 · 2009-03-20

Decision Date2009-03-20
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALLURE MB CERAMIC BRACKETS is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Interntional. It received FDA 510(k) clearance on 2009-03-20 under 510(k) number K090454. 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 ALLURE MB CERAMIC BRACKETS?

ALLURE MB CERAMIC BRACKETS is a medical device that received FDA 510(k) clearance on 2009-03-20. The listed applicant is Dentsply Interntional. The 510(k) number is K090454.

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

ALLURE MB CERAMIC BRACKETS received FDA 510(k) clearance on 2009-03-20, under 510(k) number K090454.

Who is the listed applicant for ALLURE MB CERAMIC BRACKETS?

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 ALLURE MB CERAMIC BRACKETS?

The FDA product code for ALLURE MB CERAMIC BRACKETS is NJM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Dentsply Interntional as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 13 devices →

Related Devices (Code: NJM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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