510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K894593Substantially Equivalent

Bonefit Hollow Cylinder Implants

Straumann USA, LLC, Walenburg, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894593 is the FDA 510(k) clearance record for BONEFIT HOLLOW CYLINDER IMPLANTS, a class II device, cleared for Institut Straumann AG on under FDA product code DZE (Implant, Endosseous, Root-Form). FDA records list 176 510(k) clearances for Straumann USA, LLC, from to . As of , FDA records show no recalls naming K894593.

Clearance record

Decision date
Received
(204 days to decision)
Product code
DZE Implant, Endosseous, Root-Form
Regulation
21 CFR 872.3640
Device class
Class II
Review panel
Dental
Applicant
Institut Straumann AG Ch-4437, Walenburg, CH
Third party review
No

Clearances, product code DZE

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