3I LOCATER ABUTMENT SYSTEM— 510(k) K012911
Substantially EquivalentImplant Innovations, Inc.
FDA 510(k) clearance K012911 for 3I LOCATER ABUTMENT SYSTEM, Substantially Equivalent on 2001-09-28. Applicant: Implant Innovations, Inc.. Device class: 2.
Clearance details
- Applicant
- Implant Innovations, Inc.
- 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 Implant Innovations, Inc.
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 K012911
K-number listed on FDA's recall record- Z-2427-2016 — Locator Extended Range Males 4pk Dental implants
- Z-2428-2016 — Locator Extra Light Angled Replacement Males 4pk Dental implants
- Z-2429-2016 — Locator Extra Light Retention Males 4pk Dental implants
- Z-2430-2016 — Locator Light Retention Replacement Males 4pk Dental implants
- Z-2431-2016 — Locator Replacement Housing Dental implants
- Z-2432-2016 — Locator Replacement Housing Kit Dental implants
- Z-2433-2016 — Locator Replacement Males 4pk Dental implants
- Z-2480-2016 — Locator Abutment Dental implants
- Z-2487-2016 — Certain Locator Abutment Dental implants
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012911.
Data sourced from openFDA. This site is unofficial and independent of the FDA.