SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT— 510(k) K013227
Substantially EquivalentSulzer Dental, Inc.
FDA 510(k) clearance K013227 for SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT, Substantially Equivalent on 2001-11-19. Applicant: Sulzer Dental, Inc.. Device class: 2.
Clearance details
- Applicant
- Sulzer Dental, 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
- Carlsbad, CA, US
Recent devices under product code DZE
view allMore clearances from Sulzer Dental, 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 K013227
K-number listed on FDA's recall record- Z-3206-2017 — ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, REF NEA3G; COPING GOLD NON-ENG. 4.5, REF NEA4G
- Z-2144-2014 — Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K013227.
Data sourced from openFDA. This site is unofficial and independent of the FDA.