FDA device listing

molar bands

FDA device listing 1932054422 · Ningbo Denrotary Medical Apparatus Co., Ltd.

Key facts

Proprietary names molar bands
Owner/operator Ningbo Denrotary Medical Apparatus Co., Ltd.
Owner/operator number 10096220
Product codes ECM
Device names ECM - Band, Preformed, Orthodontic
Device class Class I
Classification regulations (21 CFR) 872.5410
Review panels Dental
Registered establishments NINGBO DENROTARY MEDICAL APPARATUS CO., LTD.
Establishment operations Contract Manufacturer, Foreign Exporter, Manufacturer
Registration valid through 2026

At a glance

  • None 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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