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FDA 510(k)

SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE

K-Number: K992822 · 1999-11-17

ApplicantDentsply Intl.
Decision Date1999-11-17
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1999-11-17 under 510(k) number K992822. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE?

SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE is a medical device that received FDA 510(k) clearance on 1999-11-17. The listed applicant is Dentsply Intl.. The 510(k) number is K992822.

When did SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE receive FDA 510(k) clearance?

SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE received FDA 510(k) clearance on 1999-11-17, under 510(k) number K992822.

Who is the listed applicant for SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE?

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 SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE?

The FDA product code for SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE is LBH.

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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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