Caries Detection Product With Drug or Biologic
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Guangdong. All of them are contract manufacturers, able to build to a buyer’s own specification.
- Cicor Dongguan Co Ltd Guangdong, contract manufacturer
What Is This Device?
Intended to aid in the detection of tooth decay by measuring increased visible light, fluorescence, or luminescence induced by caries-activated drug or biologic.
How Is QJX Classified?
Caries Detection Product With Drug Or Biologic is FDA product code QJX, Class 3.
How Does It Reach the US Market?
A premarket approval is required: the Class 3 route, granted on clinical evidence rather than on equivalence to an existing device. No approval under this code names a Chinese applicant.
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