510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K050515Substantially Equivalent

Bone Block Fixation Set

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

K050515 is the FDA 510(k) clearance record for BONE BLOCK FIXATION SET, a class II device, cleared for Straumann USA, Inc. on under FDA product code DZL (Screw, Fixation, Intraosseous). FDA records list 176 510(k) clearances for Straumann USA, Inc., from to . As of , FDA records show no recalls naming K050515.

Clearance record

Decision date
Received
(35 days to decision)
Product code
DZL Screw, Fixation, Intraosseous
Regulation
21 CFR 872.4880
Device class
Class II
Review panel
Dental
Applicant
Straumann USA, Inc. 1601 Trapelo Rd., Waltham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DZL

Trailing 12 months
1 clearance under product code DZL in the twelve months to November 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DZL, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260
November 20260