FDA device listing

Agent, Polishing, Abrasive, Oral Cavity

FDA device listing 1083137140 · SHENZHEN DENCO MEDICAL CO., LTD.

Key facts

Owner/operator SHENZHEN DENCO MEDICAL CO., LTD.
Owner/operator number 10048487
Product codes EJR
Device names EJR - Agent, Polishing, Abrasive, Oral Cavity
Device class Class I
Classification regulations (21 CFR) 872.6030
Review panels Dental
Registered establishments SHENZHEN DENCO MEDICAL CO., LTD.
Establishment registrations 3011554142
FEI numbers 3011554142
Establishment operations Contract Manufacturer, Manufacturer
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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