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FDA 510(k)

PALAVIT GLC

K-Number: K904928 · 1991-06-06

ApplicantKulzer, Inc.
Decision Date1991-06-06
Product CodeEGD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PALAVIT GLC is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, Inc.. It received FDA 510(k) clearance on 1991-06-06 under 510(k) number K904928. The device is classified under product code EGD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALAVIT GLC?

PALAVIT GLC is a medical device that received FDA 510(k) clearance on 1991-06-06. The listed applicant is Kulzer, Inc.. The 510(k) number is K904928.

When did PALAVIT GLC receive FDA 510(k) clearance?

PALAVIT GLC received FDA 510(k) clearance on 1991-06-06, under 510(k) number K904928.

Who is the listed applicant for PALAVIT GLC?

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 PALAVIT GLC?

The FDA product code for PALAVIT GLC is EGD.

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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.

K905058PALAVIT LK910263CHARISMAK910719SILICOATER MDK905131DURAFILL COLOR VSK905302DENTHESIVEK904555DURAFILL FLOW

View all 31 devices →

Related Devices (Code: EGD)

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.

K020009BRACE EZEUdent, Inc.K945535GLENROE ORTHO-SILGlenroe TechnologiesK924024ORTHO WAXHeraeus Kulzer, Inc.K923586BURNOUT MATERIALDentsply Intl.K914892SALIVA-STIMOrion Diagnostica, Inc.K922380BITE RIM WAXDentsply Intl.

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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