Straumann® Dental Implant System ¿ Roxolid® SLA Implants— 510(k) K150938
Substantially EquivalentStraumann USA, LLC
FDA 510(k) clearance K150938 for Straumann® Dental Implant System ¿ Roxolid® SLA Implants, Substantially Equivalent on 2015-07-24. Applicant: Straumann USA, LLC. Device class: 2.
Clearance details
- Applicant
- Straumann USA, LLC
- 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
- Andover, MA, US
Recent devices under product code DZE
view allMore clearances from Straumann USA, LLC
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 K150938
K-number listed on FDA's recall record- Z-2534-2016 — Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510
- Z-2535-2016 — Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150938.
Data sourced from openFDA. This site is unofficial and independent of the FDA.