Air Powered Dental Handpieces and Air Motors - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

Description

This guidance document provides the FDA’s recommendations on performance criteria to support premarket submissions for air powered dental handpieces and air motors in the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using theSafety and Performance Based Pathwayfor air powered dental handpieces and air motors will have the option to use the performance criteria proposed in this final guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.  The recommendations are intended to promote consistency and facilitate efficient review of air powered dental handpieces and air motors.

Scope & Applicability

Regulatory Context

• 21CFR10.115§ 10.115 Good guidance practices.

  (a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →

• 21CFR872.4200§ 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 denRead full regulation →

• 21CFR872.4120§ 872.4120 Bone cutting instrument and accessories.

  (a) Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, poweRead full regulation →

• 21CFR872.4850§ 872.4850 Ultrasonic scaler.

  (a) Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.Read full regulation →

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