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FDA 510(k)

DENTHESIVE

K-Number: K905302 · 1991-02-26

ApplicantKulzer, Inc.
Decision Date1991-02-26
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, Inc.. It received FDA 510(k) clearance on 1991-02-26 under 510(k) number K905302. 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 DENTHESIVE?

DENTHESIVE is a medical device that received FDA 510(k) clearance on 1991-02-26. The listed applicant is Kulzer, Inc.. The 510(k) number is K905302.

When did DENTHESIVE receive FDA 510(k) clearance?

DENTHESIVE received FDA 510(k) clearance on 1991-02-26, under 510(k) number K905302.

Who is the listed applicant for DENTHESIVE?

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

What is the FDA product code for DENTHESIVE?

The FDA product code for DENTHESIVE is KLE.

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Other records listing Kulzer, Inc. as applicant

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.

K904928PALAVIT GLCK905058PALAVIT LK910263CHARISMAK910719SILICOATER MDK905131DURAFILL COLOR VSK904555DURAFILL FLOW

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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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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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