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FDA 510(k)

ULTRADENT PORCELAIN ETCH

K-Number: K951582 · 1995-05-10

ApplicantUltradent Products, Inc.
Decision Date1995-05-10
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRADENT PORCELAIN ETCH is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 1995-05-10 under 510(k) number K951582. 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 ULTRADENT PORCELAIN ETCH?

ULTRADENT PORCELAIN ETCH is a medical device that received FDA 510(k) clearance on 1995-05-10. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K951582.

When did ULTRADENT PORCELAIN ETCH receive FDA 510(k) clearance?

ULTRADENT PORCELAIN ETCH received FDA 510(k) clearance on 1995-05-10, under 510(k) number K951582.

Who is the listed applicant for ULTRADENT PORCELAIN ETCH?

The FDA 510(k) record lists Ultradent Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRADENT PORCELAIN ETCH?

The FDA product code for ULTRADENT PORCELAIN ETCH 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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