510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133488Substantially Equivalent

Piezomed

W & H DentalWerk Buermoos GmbH, Burmoos, AT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133488 is the FDA 510(k) clearance record for PIEZOMED, a class II device, cleared for W&H Dentalwerk Buermoos GmbH on under FDA product code DZI (Drill, Bone, Powered). FDA records list 18 510(k) clearances for W&H Dentalwerk Buermoos GmbH, from to . As of , FDA records show no recalls naming K133488.

Clearance record

Decision date
Received
(337 days to decision)
Product code
DZI Drill, Bone, Powered
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
W&H Dentalwerk Buermoos GmbH Ignaz-Glaser-Strasse 53, Burmoos, AT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DZI

Trailing 12 months
3 clearances under product code DZI in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DZI, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260