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FDA 510(k)

SEAL & PROTECT PROTECTIVE SEALANT

K-Number: K021805 · 2002-08-19

ApplicantDentsply Intl.
Decision Date2002-08-19
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SEAL & PROTECT PROTECTIVE SEALANT is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2002-08-19 under 510(k) number K021805. 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?

SEAL & PROTECT PROTECTIVE SEALANT is a medical device that received FDA 510(k) clearance on 2002-08-19. The listed applicant is Dentsply Intl.. The 510(k) number is K021805.

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

SEAL & PROTECT PROTECTIVE SEALANT received FDA 510(k) clearance on 2002-08-19, under 510(k) number K021805.

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

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?

The FDA product code for SEAL & PROTECT PROTECTIVE SEALANT 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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