FDA device listing

Soflex / Enhance polishing

FDA device listing 1931799625 · SAMTRADE SUPPLIES INC.

Key facts

Proprietary names Soflex / Enhance polishing
Owner/operator SAMTRADE SUPPLIES INC.
Owner/operator number 10056140
Product codes EHJ
Device names EHJ - Disk, Abrasive
Device class Class I
Classification regulations (21 CFR) 872.6010
Review panels Dental
Registered establishments SAMTRADE SUPPLIES INC.
Establishment registrations 3008912871
FEI numbers 3008912871
Establishment operations Foreign Exporter
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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