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FDA 510(k)

ULTRADENT UNIVERSAL DENTIN SEALANT

K-Number: K963979 · 1996-12-12

ApplicantUltradent Products, Inc.
Decision Date1996-12-12
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRADENT UNIVERSAL DENTIN SEALANT 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 1996-12-12 under 510(k) number K963979. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRADENT UNIVERSAL DENTIN SEALANT?

ULTRADENT UNIVERSAL DENTIN SEALANT is a medical device that received FDA 510(k) clearance on 1996-12-12. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K963979.

When did ULTRADENT UNIVERSAL DENTIN SEALANT receive FDA 510(k) clearance?

ULTRADENT UNIVERSAL DENTIN SEALANT received FDA 510(k) clearance on 1996-12-12, under 510(k) number K963979.

Who is the listed applicant for ULTRADENT UNIVERSAL DENTIN SEALANT?

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 UNIVERSAL DENTIN SEALANT?

The FDA product code for ULTRADENT UNIVERSAL DENTIN SEALANT is LBH.

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Related Devices (Code: LBH)

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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