TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS— 510(k) K122855

Name: FDA 510(k) clearance K122855
Creator: U.S. Food and Drug Administration
Published: 2012-12-12

Substantially Equivalent

Straumann USA

FDA 510(k) clearance K122855 for TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS, Substantially Equivalent on 2012-12-12. Applicant: Straumann USA. Device class: 2.

Clearance details

Applicant: Straumann USA
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2012-09-18
Decision date: 2012-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

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K250806 — Dental Implant System2026-06-18
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K260006 — INOSS System2026-06-17

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K121131 — BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM2012-06-06
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Adverse 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, 2020-01-01 through 2026-04-23. 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.