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FDA 510(k)

KULZER DENTIN ADHESIVE

K-Number: K850965 · 1985-04-22

ApplicantKulzer, Inc.
Decision Date1985-04-22
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KULZER DENTIN ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, Inc.. It received FDA 510(k) clearance on 1985-04-22 under 510(k) number K850965. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KULZER DENTIN ADHESIVE?

KULZER DENTIN ADHESIVE is a medical device that received FDA 510(k) clearance on 1985-04-22. The listed applicant is Kulzer, Inc.. The 510(k) number is K850965.

When did KULZER DENTIN ADHESIVE receive FDA 510(k) clearance?

KULZER DENTIN ADHESIVE received FDA 510(k) clearance on 1985-04-22, under 510(k) number K850965.

Who is the listed applicant for KULZER DENTIN ADHESIVE?

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 KULZER DENTIN ADHESIVE?

The FDA product code for KULZER DENTIN ADHESIVE is EBF.

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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 VSK905302DENTHESIVE

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Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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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