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FDA 510(k)

DURASHIELD PLUS

K-Number: K082198 · 2008-10-29

ApplicantDentsply Intl., Inc.
Decision Date2008-10-29
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DURASHIELD PLUS 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 2008-10-29 under 510(k) number K082198. 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 DURASHIELD PLUS?

DURASHIELD PLUS is a medical device that received FDA 510(k) clearance on 2008-10-29. The listed applicant is Dentsply Intl., Inc.. The 510(k) number is K082198.

When did DURASHIELD PLUS receive FDA 510(k) clearance?

DURASHIELD PLUS received FDA 510(k) clearance on 2008-10-29, under 510(k) number K082198.

Who is the listed applicant for DURASHIELD PLUS?

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 DURASHIELD PLUS?

The FDA product code for DURASHIELD PLUS is LBH.

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Other records listing Dentsply Intl., Inc. as applicant

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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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