FDA device listing

Oral Appliance Cleaning Tablets

FDA device listing 1809146321 · Erskine Dental

Key facts

Proprietary names Oral Appliance Cleaning Tablets
Owner/operator Erskine Dental
Owner/operator number 9079903
Product codes EFT
Device names EFT - Cleanser, Denture, Over The Counter
Device class Class I
Classification regulations (21 CFR) 872.3520
Review panels Dental
Registered establishments ERSKINE DENTAL
Establishment registrations 3003491259
FEI numbers 3003491259
Establishment operations Foreign Exporter, Specification Developer
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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