FDA device listing

Handpiece, Contra- And Right-Angle Attachment, Dental

FDA device listing 1048370629 · PETER BRASSELER HOLDINGS, L.L.C.

Key facts

Owner/operator PETER BRASSELER HOLDINGS, L.L.C.
Owner/operator number 1032227
Premarket submissions K962540
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 BRASSELER U.S.A. DENTAL, LLC
Establishment registrations 1032227
FEI numbers 1032227
Establishment operations Repackager/Relabeler
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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