TCM 3000 AND TCM ENDO— 510(k) K981679

Substantially Equivalent

NOUVAG AG

FDA 510(k) clearance K981679 for TCM 3000 AND TCM ENDO, Substantially Equivalent on 1999-02-09. Applicant: NOUVAG AG.

Clearance details

Applicant: NOUVAG AG
Product code: Code EFB
Advisory panel: Dental
Date received: 1998-05-13
Decision date: 1999-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaufbeuren, DE

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Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

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.