STRAUMANN BONE LEVEL TAPERED IMPLANT— 510(k) K140878
Substantially EquivalentStraumann USA, LLC
FDA 510(k) clearance K140878 for STRAUMANN BONE LEVEL TAPERED IMPLANT, Substantially Equivalent on 2014-08-20. 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 K140878
K-number listed on FDA's recall record- Z-2935-2026 — Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
- Z-0117-2015 — Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140878.
Data sourced from openFDA. This site is unofficial and independent of the FDA.