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Dental Stereotaxic Instrument

Page Type
Product Code
Definition
To facilitate dental implant placement in patients that are partially endentulous or edentulous.
Physical State
A cart mounted system that physically attaches to the patient as well as the surgical instrument in order to detect the location of the device in physical space.
Technical Method
The device uses stereo cameras to detect tracking devices placed on both the surgical instrument as well as on the patient. The tracked image is then placed on a screen with predetermined anatomical landmarks to assist the clinician with the surgical placement.
Target Area
Intraoral surgical procedures in the mouth.
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
Eligible
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 Stereotaxic Instrument

Page Type
Product Code
Definition
To facilitate dental implant placement in patients that are partially endentulous or edentulous.
Physical State
A cart mounted system that physically attaches to the patient as well as the surgical instrument in order to detect the location of the device in physical space.
Technical Method
The device uses stereo cameras to detect tracking devices placed on both the surgical instrument as well as on the patient. The tracked image is then placed on a screen with predetermined anatomical landmarks to assist the clinician with the surgical placement.
Target Area
Intraoral surgical procedures in the mouth.
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
Eligible
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.