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Powered Tongue Scraper

Page Type
Product Code
Definition
The device is intended to remove debris from the top surface of the tongue as a supplement to normal daily oral hygiene care.
Physical State
The device is composed of a rounded plastic scraping head on a handle containing integrated software and hardware that provides power, low-vibratory tactile frequency, and ultrasonic frequency.
Technical Method
The device utilizes pressure from the patient’s hand, and generated tactile vibrations and ultrasonic pressure waves for the purposes of cleaning the tongue in a scraping motion. The device uses integrated software and hardware to control power cycles, low-vibratory tactile frequency, and ultrasonic frequency.
Target Area
Oral environment
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.6865
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.6865 Powered toothbrush

§ 872.6865 Powered toothbrush.

(a) Identification. A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

[55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38800, July 25, 2001]

Powered Tongue Scraper

Page Type
Product Code
Definition
The device is intended to remove debris from the top surface of the tongue as a supplement to normal daily oral hygiene care.
Physical State
The device is composed of a rounded plastic scraping head on a handle containing integrated software and hardware that provides power, low-vibratory tactile frequency, and ultrasonic frequency.
Technical Method
The device utilizes pressure from the patient’s hand, and generated tactile vibrations and ultrasonic pressure waves for the purposes of cleaning the tongue in a scraping motion. The device uses integrated software and hardware to control power cycles, low-vibratory tactile frequency, and ultrasonic frequency.
Target Area
Oral environment
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.6865
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.6865 Powered toothbrush

§ 872.6865 Powered toothbrush.

(a) Identification. A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

[55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38800, July 25, 2001]