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FDA 510(k)

PERMAQUIK BONDING PRIMER

K-Number: K951867 · 1995-05-23

ApplicantUltradent Products, Inc.
Decision Date1995-05-23
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERMAQUIK BONDING PRIMER 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 1995-05-23 under 510(k) number K951867. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERMAQUIK BONDING PRIMER?

PERMAQUIK BONDING PRIMER is a medical device that received FDA 510(k) clearance on 1995-05-23. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K951867.

When did PERMAQUIK BONDING PRIMER receive FDA 510(k) clearance?

PERMAQUIK BONDING PRIMER received FDA 510(k) clearance on 1995-05-23, under 510(k) number K951867.

Who is the listed applicant for PERMAQUIK BONDING PRIMER?

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 PERMAQUIK BONDING PRIMER?

The FDA product code for PERMAQUIK BONDING PRIMER is KLE.

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Other records listing Ultradent Products, Inc. as applicant

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Related Devices (Code: KLE)

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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