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FDA 510(k)

PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS

K-Number: K130076 · 2013-08-22

ApplicantMerz Dental GmbH
Decision Date2013-08-22
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS 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 2013-08-22 under 510(k) number K130076. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS?

PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS is a medical device that received FDA 510(k) clearance on 2013-08-22. The listed applicant is Merz Dental GmbH. The 510(k) number is K130076.

When did PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS receive FDA 510(k) clearance?

PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS received FDA 510(k) clearance on 2013-08-22, under 510(k) number K130076.

Who is the listed applicant for PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS?

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 PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS?

The FDA product code for PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS is EBI.

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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 BiosolutionK120404MERZ 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 IMCROWNK030588ARTEGRAL AND POLYSTAR SELECTION

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Related Devices (Code: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.

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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