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FDA 510(k)

DENTALON

K-Number: K831077 · 1983-09-12

ApplicantKulzer, Inc.
Decision Date1983-09-12
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTALON is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, Inc.. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K831077. 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 DENTALON?

DENTALON is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Kulzer, Inc.. The 510(k) number is K831077.

When did DENTALON receive FDA 510(k) clearance?

DENTALON received FDA 510(k) clearance on 1983-09-12, under 510(k) number K831077.

Who is the listed applicant for DENTALON?

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 DENTALON?

The FDA product code for DENTALON is EBG.

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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: 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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