PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS— 510(k) K130076

Name: FDA 510(k) clearance K130076
Creator: U.S. Food and Drug Administration
Published: 2013-08-22

Substantially Equivalent

Merz Dental GmbH

FDA 510(k) clearance K130076 for PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS, Substantially Equivalent on 2013-08-22. Applicant: Merz Dental GmbH. Device class: 2.

Clearance details

Applicant: Merz Dental GmbH
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2013-01-14
Decision date: 2013-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Albuquerque, NM, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBI

view all

K261802 — Glidewell Denture Base Resin2026-08-27
K261626 — UltraPrint Flexible Denture UV2026-08-13
K262681 — NanoCeram Resin2026-07-31
K262300 — Denture Base Resin V22026-07-08
K261474 — DENTCA Tru Flexible2026-07-01

More clearances from Merz Dental GmbH

view all

K173124 — PEEK Biosolution2017-12-18
K140758 — M-PM-DISC (PINK)2014-09-15
K134015 — M-PM-DISC2014-04-11
K120404 — MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH2012-05-21
K080556 — ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES2008-05-02

Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.