OVERDENTURE ATTACHMENT— 510(k) K891613
Substantially EquivalentImplant Innovations International, Inc.
FDA 510(k) clearance K891613 for OVERDENTURE ATTACHMENT, Substantially Equivalent on 1989-10-10. Applicant: Implant Innovations International, Inc.. Device class: 2.
Clearance details
- Applicant
- Implant Innovations International, 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
- West Palm Beach, FL, US
Recent devices under product code DZE
view allMore clearances from Implant Innovations International, 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 K891613
K-number listed on FDA's recall record- Z-2424-2016 — O-Ring Abutment 4.1mm(D) x 2mm(H) Item: OSO20 Dental implants
- Z-2425-2016 — O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants
- Z-2426-2016 — O-Ring Abutment 4.1mm(D) x 6mm(H) Item: OSO60 Dental implants
- Z-2459-2016 — DAL-RO Housing, Female Assembly Dental implants
- Z-2460-2016 — DAL-RO Abutment Dental implants
- Z-2461-2016 — DAL-RO Threaded Female Dental implants
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K891613.
Data sourced from openFDA. This site is unofficial and independent of the FDA.