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Prophy Powder, Airbrush Accessory

Page Type
Product Code
Definition
An air polishing powder to be used with an airbrush for prophylaxis in the oral cavity.
Physical State
Powder
Technical Method
The powder is dispensed via an electric airbrush and removes plaque via abrasion of the tooth surface by the powder granules.
Target Area
Oral cavity
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.6080
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.6080 Airbrush

§ 872.6080 Airbrush.

(a) Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.

(b) Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment - Part 1: General Requirements for Safety.”

[52 FR 30097, Aug. 12, 1987; 52 FR 49250, Dec. 30, 1987, as amended at 71 FR 17144, Mar. 31, 2006]

Prophy Powder, Airbrush Accessory

Page Type
Product Code
Definition
An air polishing powder to be used with an airbrush for prophylaxis in the oral cavity.
Physical State
Powder
Technical Method
The powder is dispensed via an electric airbrush and removes plaque via abrasion of the tooth surface by the powder granules.
Target Area
Oral cavity
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.6080
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.6080 Airbrush

§ 872.6080 Airbrush.

(a) Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.

(b) Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment - Part 1: General Requirements for Safety.”

[52 FR 30097, Aug. 12, 1987; 52 FR 49250, Dec. 30, 1987, as amended at 71 FR 17144, Mar. 31, 2006]