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FDA 510(k)

PERMASHADE VENEER CEMENT

K-Number: K111836 · 2011-09-16

ApplicantUltradent Products, Inc.
Decision Date2011-09-16
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERMASHADE VENEER CEMENT 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 2011-09-16 under 510(k) number K111836. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERMASHADE VENEER CEMENT?

PERMASHADE VENEER CEMENT is a medical device that received FDA 510(k) clearance on 2011-09-16. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K111836.

When did PERMASHADE VENEER CEMENT receive FDA 510(k) clearance?

PERMASHADE VENEER CEMENT received FDA 510(k) clearance on 2011-09-16, under 510(k) number K111836.

Who is the listed applicant for PERMASHADE VENEER CEMENT?

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 PERMASHADE VENEER CEMENT?

The FDA product code for PERMASHADE VENEER CEMENT is EMA.

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Related Devices (Code: EMA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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