ATR 3000, ATR 2000, IMPLANT-PRO— 510(k) K991401

Substantially Equivalent

Advanced Technology Research (A.T.R.) S.R.P.

FDA 510(k) clearance K991401 for ATR 3000, ATR 2000, IMPLANT-PRO, Substantially Equivalent on 1999-12-15. Applicant: Advanced Technology Research (A.T.R.) S.R.P..

Clearance details

Applicant: Advanced Technology Research (A.T.R.) S.R.P.
Product code: Code EFB
Advisory panel: Dental
Date received: 1999-04-22
Decision date: 1999-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, CA, US

Download summary PDF View on FDA.gov ↗

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.