K081191 is the FDA 510(k) clearance record for TCM ENDO 20, a class I device, cleared for NOUVAG AG on 2008-08-07 under FDA product code EKX (Handpiece, Direct Drive, Ac-Powered). FDA records list 11 510(k) clearances for NOUVAG AG, from 1996-01-16 to 2009-06-29 . As of 2026-09-10 , FDA records show no recalls naming K081191.
Clearance record Decision date 2008-08-07 Received 2008-04-28 (101 days to decision) Product code EKX Handpiece, Direct Drive, Ac-PoweredRegulation 21 CFR 872.4200 Device class Class I Review panel Dental Applicant Nouvag Ag Reusswehrstrasse 1, Gebenstorf, CH 510(k) summary Summary PDF ↗ Third party review No
Clearances, product code EKX Trailing 12 months 1 clearance under product code EKX in the twelve months to October 2026, September 2026 the highest month at 1. Show the numbers FIRST ARTICLE / WEEKLY
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Product code EKX
FDA records show no recalls under product code EKX.
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 2026-09-28 , the FDA export date for this dataset. Page last changed 2026-09-05 . View this record on fda.gov ↗ (opens on fda.gov)
