FDA device listing

BE LUCENT NHpro Enamel Care; BE LUCENT HA5 Gum Serum,Charcoal Teeth Whitening Powder/ Teeth Whitening Powder/ Coconut…

FDA device listing 1024580804 · Jiangxi Ushine Bright Medical Co., Ltd.

Key facts

Proprietary names BE LUCENT NHpro Enamel Care; BE LUCENT HA5 Gum Serum,Charcoal Teeth Whitening Powder/ Teeth Whitening Powder/ Coconut Oil Pulling/ Coconut Oil Sachet/ Dual Barrel Gel/,Charcoal Teeth Whitening Strips/ V34 Teeth Whitening Strips/ Teeth Whitening Essence/ Teeth Whitening Foam/,Double Barrel Gel/ Double Barrel Syringe Gel/ Teeth Remineralization Gel/ Teeth Desensitizing Gel/ Teeth Whitening Kit/,Oral…
Owner/operator Jiangxi Ushine Bright Medical Co., Ltd.
Owner/operator number 10089595
Product codes MAU
Device names MAU - Eraser, Dental Stain
Device class Class I
Classification regulations (21 CFR) 872.6855
Review panels Dental
Registered establishments Jiangxi Ushine Bright Medical Co., Ltd.
Establishment registrations 3023895623
FEI numbers 3023895623
Establishment operations Contract Manufacturer, Foreign Exporter, 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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