K082285 is the FDA 510(k) clearance record for EASY GLAZE, a class II device, cleared for Voco GmbH on 2008-10-24 under FDA product code EBD (Coating, Filling Material, Resin). FDA records list 78 510(k) clearances for Voco GmbH, from 2003-05-30 to 2026-05-01 . As of 2026-09-10 , FDA records show no recalls naming K082285.
Clearance record Decision date 2008-10-24 Received 2008-08-11 (74 days to decision) Product code EBD Coating, Filling Material, ResinRegulation 21 CFR 872.3310 Device class Class II Review panel Dental Applicant Voco GmbH Anton-Flettner-Strasse 1-3, Cuxhaven, DE 510(k) summary Summary PDF ↗ Third party review No
Clearances, product code EBD Trailing 12 months 1 clearance under product code EBD in the twelve months to November 2026, April 2026 the highest month at 1. Show the numbers FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
Product code EBD
FDA records show no recalls under product code EBD.
MDM coverage of this record lists here, newest first.
About this record Sourced from the FDA 510(k) premarket notification database, ingested from openFDA. MDM adds the decision time in days, the product code cross-link, recalls sharing that product code, and MDM coverage of the record.
Predicate devices are not listed. The openFDA 510(k) endpoint does not publish predicate references, so MDM does not assert them. Where a 510(k) summary exists, the FDA PDF is linked above and names the predicate itself.
Data as of 2026-10-26 , the FDA export date for this dataset. Page last changed 2026-09-05 . View this record on fda.gov ↗ (opens on fda.gov)
