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FDA 510(k)

ARTEGRAL AND POLYSTAR SELECTION

K-Number: K030588 · 2003-05-07

ApplicantMerz Dental GmbH
Decision Date2003-05-07
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ARTEGRAL AND POLYSTAR SELECTION 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 2003-05-07 under 510(k) number K030588. 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 ARTEGRAL AND POLYSTAR SELECTION?

ARTEGRAL AND POLYSTAR SELECTION is a medical device that received FDA 510(k) clearance on 2003-05-07. The listed applicant is Merz Dental GmbH. The 510(k) number is K030588.

When did ARTEGRAL AND POLYSTAR SELECTION receive FDA 510(k) clearance?

ARTEGRAL AND POLYSTAR SELECTION received FDA 510(k) clearance on 2003-05-07, under 510(k) number K030588.

Who is the listed applicant for ARTEGRAL AND POLYSTAR SELECTION?

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 ARTEGRAL AND POLYSTAR SELECTION?

The FDA product code for ARTEGRAL AND POLYSTAR SELECTION 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 PCSK120404MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHK080556ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADESK071548WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLOREDK061809ARTEGRAL IMCROWN

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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 CorporationK120404MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHMerz Dental GmbHK120736SR PHONARES IIIvoclar Vivadent, AG

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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