ATR 3000, ATR 2000, IMPLANT-PRO— 510(k) K991401
Substantially EquivalentAdvanced 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.. Device class: 1.
Clearance details
- Applicant
- Advanced Technology Research (A.T.R.) S.R.P.
- Product code
- Code EFB
- Device class
- Class 1
- Regulation
- 21 CFR 872.4200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Forest, CA, US
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More clearances from Advanced Technology Research (A.T.R.) S.R.P.
view allAdverse events under product code EFB
product code EFB- Injury
- 133
- Malfunction
- 562
- Total
- 695
Source: openFDA MAUDE database, through . 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.