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FDA 510(k)

PALAVIT 55 AND DENTACOLOR CONNECTOR

K-Number: K932034 · 1993-08-06

ApplicantHeraeus Kulzer, Inc.
Decision Date1993-08-06
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PALAVIT 55 AND DENTACOLOR CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1993-08-06 under 510(k) number K932034. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALAVIT 55 AND DENTACOLOR CONNECTOR?

PALAVIT 55 AND DENTACOLOR CONNECTOR is a medical device that received FDA 510(k) clearance on 1993-08-06. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K932034.

When did PALAVIT 55 AND DENTACOLOR CONNECTOR receive FDA 510(k) clearance?

PALAVIT 55 AND DENTACOLOR CONNECTOR received FDA 510(k) clearance on 1993-08-06, under 510(k) number K932034.

Who is the listed applicant for PALAVIT 55 AND DENTACOLOR CONNECTOR?

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

What is the FDA product code for PALAVIT 55 AND DENTACOLOR CONNECTOR?

The FDA product code for PALAVIT 55 AND DENTACOLOR CONNECTOR is EBG.

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Other records listing Heraeus 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.

K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

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Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

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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