Facility

W&H DENTALWERK BUERMOOS GMBH - SITE 2

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3011300255
Establishment type	Export Device to the United States But Perform No Other Operation on Device; Manufacture Medical Device
Location	WERNER-BADER-STRASSE 1 BUERMOOS Salzburg, AT 5111
Registration status	Active · expires 2026
Parent company	W&H Dentalwerk Buermoos GmbH (owner-operator 9032044)

Activity by year

Recalls (1)

Devices registered here (8)

Scaler, Ultrasonic
Product code ELC (opens in a new tab) · Class II · Dental · 21 CFR 872.4850
Locator, Root Apex
Product code LQY (opens in a new tab) · Unclassified · Unknown
Activator, Ultraviolet, For Polymerization
Product code EBZ (opens in a new tab) · Class II · Dental · 21 CFR 872.6070
Drill, Bone, Powered
Product code DZI (opens in a new tab) · Class II · Dental · 21 CFR 872.4120
Handpiece, Direct Drive, Ac-Powered
Product code EKX (opens in a new tab) · Class I · Dental · 21 CFR 872.4200
Plugger, Root Canal, Endodontic
Product code EKR (opens in a new tab) · Class I · Dental · 21 CFR 872.4565
Unit, Operative Dental
Product code EIA (opens in a new tab) · Class I · Dental · 21 CFR 872.6640
Handpiece, Belt And/Or Gear Driven, Dental
Product code EFA (opens in a new tab) · Class I · Dental · 21 CFR 872.4200

Recalls & enforcement

Class IIOngoing2024-01-16
1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific laser marking should read 1:2, but instead it reads 1:1 on the body of the handpiece

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “W&H DENTALWERK BUERMOOS GMBH - SITE 2 (FEI 3011300255) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011300255-w-h-dentalwerk-buermoos-gmbh-site-2/

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