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FDA 510(k)

MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH

K-Number: K120404 · 2012-05-21

ApplicantMerz Dental GmbH
Decision Date2012-05-21
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH is the device name listed in this FDA 510(k) record. The listed applicant is Merz Dental GmbH. It received FDA 510(k) clearance on 2012-05-21 under 510(k) number K120404. The device is classified under product code ELM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH?

MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH is a medical device that received FDA 510(k) clearance on 2012-05-21. The listed applicant is Merz Dental GmbH. The 510(k) number is K120404.

When did MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH receive FDA 510(k) clearance?

MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH received FDA 510(k) clearance on 2012-05-21, under 510(k) number K120404.

Who is the listed applicant for MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH?

The FDA 510(k) record lists Merz Dental GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH?

The FDA product code for MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH is ELM.

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Other records listing Merz Dental GmbH 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.

K173124PEEK BiosolutionK130076PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCSK080556ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADESK071548WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLOREDK061809ARTEGRAL IMCROWNK030588ARTEGRAL AND POLYSTAR SELECTION

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Related Devices (Code: ELM)

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.

K122955DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUMWright Health Group , Ltd.K122925NEW STETIC ARTIFICIAL TEETHNew SteticK122852PHYSIOSTAR NFCCandulor USA, Inc.K121749VERACIAShofu Dental CorporationK120736SR PHONARES IIIvoclar Vivadent, AGK113426VERACIA SAShofu Dental Corporation

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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