BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM— 510(k) K121131

Name: FDA 510(k) clearance K121131
Creator: U.S. Food and Drug Administration
Published: 2012-06-06

Substantially Equivalent

Straumann USA

FDA 510(k) clearance K121131 for BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM, Substantially Equivalent on 2012-06-06. 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: 2012-04-13
Decision date: 2012-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

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K260463 — ZEROS Dental Implant System2026-08-19
K251188 — UNIQA® Dental Implants System2026-06-25
K250806 — Dental Implant System2026-06-18
K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

More clearances from Straumann USA

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K151328 — PURE Ceramic Implants2016-01-11
K130724 — CODIAGNOSTIX IMPLANT PLANNING SOFTWARE2013-06-28
K130808 — STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS2013-06-28
K122855 — TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS2012-12-12
K113606 — NNC GOLD ABUTMENT FOR BRIDGES2012-01-27

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 →

Recalls naming K121131

K-number listed on FDA's recall record

Z-0174-2015 — Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: 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. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be usedClass II·Terminated·Straumann USA, LLC·20140924

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121131.

Data sourced from openFDA. This site is unofficial and independent of the FDA.