510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984508Substantially Equivalent

Surgical Contra-Angle Handpieces, Models 975 Ae,979 E/km, 985 Ae, 986 Ae, 988 E/km and Surgical Straight Handpieces Mod

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

K984508 is the FDA 510(k) clearance record for SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD, a class I device, cleared for W&H Dentalwerk Buermoos GmbH on under FDA product code DZA (Drill, Dental, Intraoral). FDA records list 18 510(k) clearances for W&H Dentalwerk Buermoos GmbH, from to . As of , FDA records show no recalls naming K984508.

Clearance record

Decision date
Received
(189 days to decision)
Product code
DZA Drill, Dental, Intraoral
Regulation
21 CFR 872.4130
Device class
Class I
Review panel
Dental
Applicant
W&H Dentalwerk Buermoos GmbH 53 Ignaz-Glaser-Strasse, Buermoos, AT
510(k) summary
Statement
Third party review
No

Clearances, product code DZA

Trailing 12 months

FDA records hold no clearances under product code DZA in the trailing twelve months.

FDA records show no clearances under product code DZA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DZA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260