FDA device listing

BUR HOLDER,BUR RETAINER CASE,METAL BURS HOLDER,PLASTIC HOLDER

FDA device listing 1581670459 · WUXI LYUSMILE IMP AND EXP CO.,LTD

Key facts

Proprietary names BUR HOLDER,BUR RETAINER CASE,METAL BURS HOLDER,PLASTIC HOLDER
Owner/operator WUXI LYUSMILE IMP AND EXP CO.,LTD
Owner/operator number 10082225
Product codes DZP
Device names DZP - Instrument, Diamond, Dental
Device class Class I
Classification regulations (21 CFR) 872.4535
Review panels Dental
Registered establishments WUXI LYUSMILE IMP AND EXP CO.,LTD
Establishment registrations 3021023132
FEI numbers 3021023132
Establishment operations Foreign Private Label Distributor
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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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