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FDA 510(k)

DENOPTIX BARRIER ENVELOPE (SIZE 0-4)

K-Number: K980543 · 1998-04-14

ApplicantDentsply Intl.
Decision Date1998-04-14
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENOPTIX BARRIER ENVELOPE (SIZE 0-4) is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1998-04-14 under 510(k) number K980543. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENOPTIX BARRIER ENVELOPE (SIZE 0-4)?

DENOPTIX BARRIER ENVELOPE (SIZE 0-4) is a medical device that received FDA 510(k) clearance on 1998-04-14. The listed applicant is Dentsply Intl.. The 510(k) number is K980543.

When did DENOPTIX BARRIER ENVELOPE (SIZE 0-4) receive FDA 510(k) clearance?

DENOPTIX BARRIER ENVELOPE (SIZE 0-4) received FDA 510(k) clearance on 1998-04-14, under 510(k) number K980543.

Who is the listed applicant for DENOPTIX BARRIER ENVELOPE (SIZE 0-4)?

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 DENOPTIX BARRIER ENVELOPE (SIZE 0-4)?

The FDA product code for DENOPTIX BARRIER ENVELOPE (SIZE 0-4) is EHD.

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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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