K040769 is the FDA 510(k) clearance record for STRUCTUR 2 SC, a class II device, cleared for Voco GmbH on 2004-04-07 under FDA product code EBG (Crown And Bridge, Temporary, Resin). FDA records list 13 510(k) clearances for Voco GmbH, from 2002-07-19 to 2005-07-27 . As of 2026-09-10 , FDA records show one recall naming K040769.
Clearance record Decision date 2004-04-07 Received 2004-03-25 (13 days to decision) Product code EBG Crown And Bridge, Temporary, ResinRegulation 21 CFR 872.3770 Device class Class II Review panel Dental Applicant Voco GmbH 19379 Blue Lake Loop, Bend OR 510(k) summary Statement Third party review No
Clearances, product code EBG Trailing 12 months 2 clearances under product code EBG in the twelve months to October 2026, March 2026 the highest month at 1. Show the numbers FIRST ARTICLE / WEEKLY
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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 2026-09-28 , the FDA export date for this dataset. Page last changed 2026-09-05 . View this record on fda.gov ↗ (opens on fda.gov)
