PREFORMANCE POSTS— 510(k) K053170
Substantially EquivalentImplant Innovations, Inc.
FDA 510(k) clearance K053170 for PREFORMANCE POSTS, Substantially Equivalent on 2006-02-01. Applicant: Implant Innovations, Inc.. Device class: 2.
Clearance details
- Applicant
- Implant Innovations, Inc.
- Product code
- Code NHA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3630
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palm Beach Gardens, FL, US
Recent devices under product code NHA
view allMore clearances from Implant Innovations, Inc.
view allAdverse events under product code NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
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 K053170
K-number listed on FDA's recall record- Z-2414-2016 — Certain Pick-Up Coping 4.1mm(D) x 4.1mm(P) Item: IIIC41 Dental implants
- Z-2491-2016 — Certain Preformance 15 degrees Pre-Angled Post Dental implants
- Z-2492-2016 — Certain Preformance Post Dental implants
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K053170.
Data sourced from openFDA. This site is unofficial and independent of the FDA.