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Handpiece, Air-Powered, Root Canal Irrigation

Page Type
Product Code
Definition
To clean the root canal prior to filling and used for root canal irrigation.
Physical State
It is composed or aluminum, stainless steel and plastic
Technical Method
It is attached to the coupling for the dental handpiece and is used to provide irrigation solution into the root canal
Target Area
It is used to treat a tooth during a root canal procedure
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
872.4200
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.4200 Dental handpiece and accessories

§ 872.4200 Dental handpiece and accessories.

(a) Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

(b) Classification. Class I.

[55 FR 48439, Nov. 20, 1990]

Handpiece, Air-Powered, Root Canal Irrigation

Page Type
Product Code
Definition
To clean the root canal prior to filling and used for root canal irrigation.
Physical State
It is composed or aluminum, stainless steel and plastic
Technical Method
It is attached to the coupling for the dental handpiece and is used to provide irrigation solution into the root canal
Target Area
It is used to treat a tooth during a root canal procedure
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
872.4200
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.4200 Dental handpiece and accessories

§ 872.4200 Dental handpiece and accessories.

(a) Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

(b) Classification. Class I.

[55 FR 48439, Nov. 20, 1990]