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Device, Caries Detection

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.1740
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.1740 Caries detection device

§ 872.1740 Caries detection device.

(a) Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.

(b) Classification. Class II.

Device, Caries Detection

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.1740
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.1740 Caries detection device

§ 872.1740 Caries detection device.

(a) Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.

(b) Classification. Class II.