FDA device listing

Teeth Whitening Kit

FDA device listing 1047389880 · Huizhou Gold Rose Technology Co.,Ltd

Key facts

Proprietary names Teeth Whitening Kit
Owner/operator Huizhou Gold Rose Technology Co.,Ltd
Owner/operator number 10078391
Product codes MAU
Device names MAU - Eraser, Dental Stain
Device class Class I
Classification regulations (21 CFR) 872.6855
Review panels Dental
Registered establishments HUIZHOU GOLD ROSE TECHNOLOGY CO.,LTD
Establishment registrations 3017618900
FEI numbers 3017618900
Establishment operations Contract Manufacturer, Foreign Exporter, Manufacturer, Repackager/Relabeler
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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