510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K121131Substantially Equivalent

Bl, 04.1 Mm Rc, Slactive 8Mm, Tizr and 10Mm, 12, 14Mm

Straumann USA, LLC, Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121131 is the FDA 510(k) clearance record for BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM, a class II device, cleared for Straumann USA on under FDA product code DZE (Implant, Endosseous, Root-Form). FDA records list 176 510(k) clearances for Straumann USA, from to . As of , FDA records show one recall naming K121131.

Clearance record

Decision date
Received
(54 days to decision)
Product code
DZE Implant, Endosseous, Root-Form
Regulation
21 CFR 872.3640
Device class
Class II
Review panel
Dental
Applicant
Straumann USA 60 Minuteman Rd., Andover MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DZE

Trailing 12 months
19 clearances under product code DZE in the twelve months to October 2026, December 2025 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code DZE, trailing twelve months
MonthClearances
November 20251
December 20254
January 20261
February 20262
March 20264
April 20260
May 20261
June 20264
July 20260
August 20261
September 20261
October 20260