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FDA 510(k)

MOUTHGUARD AND ALIGNER MATERIALS

K-Number: K062828 · 2006-11-27

ApplicantDentsply Intl., Inc.
Decision Date2006-11-27
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

MOUTHGUARD AND ALIGNER MATERIALS 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 2006-11-27 under 510(k) number K062828. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOUTHGUARD AND ALIGNER MATERIALS?

MOUTHGUARD AND ALIGNER MATERIALS is a medical device that received FDA 510(k) clearance on 2006-11-27. The listed applicant is Dentsply Intl., Inc.. The 510(k) number is K062828.

When did MOUTHGUARD AND ALIGNER MATERIALS receive FDA 510(k) clearance?

MOUTHGUARD AND ALIGNER MATERIALS received FDA 510(k) clearance on 2006-11-27, under 510(k) number K062828.

Who is the listed applicant for MOUTHGUARD AND ALIGNER MATERIALS?

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 MOUTHGUARD AND ALIGNER MATERIALS?

The FDA product code for MOUTHGUARD AND ALIGNER MATERIALS is MQC.

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Related Devices (Code: MQC)

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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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