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FDA 510(k)

FINESSE ALL-CERAMIC SYSTEM

K-Number: K971869 · 1997-09-11

ApplicantDentsply Intl.
Decision Date1997-09-11
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FINESSE ALL-CERAMIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1997-09-11 under 510(k) number K971869. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FINESSE ALL-CERAMIC SYSTEM?

FINESSE ALL-CERAMIC SYSTEM is a medical device that received FDA 510(k) clearance on 1997-09-11. The listed applicant is Dentsply Intl.. The 510(k) number is K971869.

When did FINESSE ALL-CERAMIC SYSTEM receive FDA 510(k) clearance?

FINESSE ALL-CERAMIC SYSTEM received FDA 510(k) clearance on 1997-09-11, under 510(k) number K971869.

Who is the listed applicant for FINESSE ALL-CERAMIC SYSTEM?

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 FINESSE ALL-CERAMIC SYSTEM?

The FDA product code for FINESSE ALL-CERAMIC SYSTEM is EIH.

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Related Devices (Code: EIH)

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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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