T3 DENTAL IMPLANT— 510(k) K122300
Substantially EquivalentBiomet 3i
FDA 510(k) clearance K122300 for T3 DENTAL IMPLANT, Substantially Equivalent on 2013-01-30. Applicant: Biomet 3i. Device class: 2.
Clearance details
- Applicant
- Biomet 3i
- Product code
- Code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palm Beach Gardens, FL, US
Recent devices under product code DZE
view allMore clearances from Biomet 3i
view allAdverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
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 →
Recalls naming K122300
K-number listed on FDA's recall record- Z-1409-2015 — 3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants.
- Z-1960-2013 — Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
- Z-1961-2013 — Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122300.
Data sourced from openFDA. This site is unofficial and independent of the FDA.