Straumann® BLC Implants - Indication Widening— 510(k) K252168
Substantially EquivalentInstitut Straumann AG
FDA 510(k) clearance K252168 for Straumann® BLC Implants - Indication Widening, Substantially Equivalent on 2026-03-10. Applicant: Institut Straumann AG. Device class: 2.
Summary
Institut Straumann's record is titled "Straumann® BLC Implants - Indication Widening" and filed under DZE, root-form endosseous implants. The record doesn't describe the implants beyond that name and code name.
Class II, 21 CFR 872.3640. Dental is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Institut Straumann filed from Basel, Switzerland. Review took 243 calendar days (July 10, 2025 to March 10, 2026).
Clearance details
- Applicant
- Institut Straumann AG
- Product code
- Product 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
- Basel, CH
Recent devices under product code DZE
view allMore clearances from Institut Straumann AG
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.