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Dental Navigation System

Page Type
Product Code
Definition
Intended to provide real-time guidance on the orientation and location of the dental instrument relative to the patient's anatomy for general dentistry procedures.
Physical State
The dental navigation system is comprised of navigation software, user interface, patient tracker, dental instrument tracker, display screen and accessories.
Technical Method
The navigation system software receives in real-time the position of a dental instrument and the patient which is displayed on a screen.
Target Area
Intraoral for general dentistry procedures
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.4120
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.4120 Bone cutting instrument and accessories

§ 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, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.

(b) Classification. Class II.

Dental Navigation System

Page Type
Product Code
Definition
Intended to provide real-time guidance on the orientation and location of the dental instrument relative to the patient's anatomy for general dentistry procedures.
Physical State
The dental navigation system is comprised of navigation software, user interface, patient tracker, dental instrument tracker, display screen and accessories.
Technical Method
The navigation system software receives in real-time the position of a dental instrument and the patient which is displayed on a screen.
Target Area
Intraoral for general dentistry procedures
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.4120
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.4120 Bone cutting instrument and accessories

§ 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, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.

(b) Classification. Class II.