OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE— 510(k) K063286
Substantially EquivalentImplant Innovations, Inc.
FDA 510(k) clearance K063286 for OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE, Substantially Equivalent on 2007-04-24. 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 K063286
K-number listed on FDA's recall record- Z-1701-2017 — BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"
- Z-2457-2016 — Cover Screw Dental implants
- Z-2458-2016 — Cover Screw, Headless Dental implants
- Z-2469-2016 — Implant Cover Screw Dental implants
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063286.
Data sourced from openFDA. This site is unofficial and independent of the FDA.