FDA device listing

Handpiece, Contra- And Right-Angle Attachment, Dental

FDA device listing 1407813703 · W&H Dentalwerk Buermoos GmbH

Key facts

Owner/operator W&H Dentalwerk Buermoos GmbH
Owner/operator number 9032044
Premarket submissions K011061
Product codes EGS
Device names EGS - Handpiece, Contra- And Right-Angle Attachment, Dental
Device class Class I
Classification regulations (21 CFR) 872.4200
Review panels Dental
Registered establishments W&H DENTALWERK BUERMOOS GMBH, W&H DENTALWERK BUERMOOS GMBH - SITE 2
Establishment registrations 9681479, 3011300255
FEI numbers 3003755849, 3011300255
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 10–99 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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