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FDA 510(k)

FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS

K-Number: K961291 · 1996-05-28

ApplicantDentsply Intl.
Decision Date1996-05-28
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1996-05-28 under 510(k) number K961291. 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 LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS?

FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS is a medical device that received FDA 510(k) clearance on 1996-05-28. The listed applicant is Dentsply Intl.. The 510(k) number is K961291.

When did FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS receive FDA 510(k) clearance?

FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS received FDA 510(k) clearance on 1996-05-28, under 510(k) number K961291.

Who is the listed applicant for FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS?

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 LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS?

The FDA product code for FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS 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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