Last synced on 23 September 2022 at 11:05 pm

Diagnostic Light, Soft Tissue Detector

Page Type
Product Code
Definition
To be used as an aid in the detection or visualization of abnormalities of intraoral soft tissue. An adjunct to traditional intraoral examination by incandescent light to enhance the visualization of oral mucosal abnormalities
Physical State
The device consists of a light source with light guide cable or a handpiece based light emitting apparatus. Added components may or may not block or filter out light inundesired frequencies. The reflected light reveals tissue characteristics that are abnormal, or are suspected to be abnormal.
Technical Method
The device emits a light in a specific wavelength range causing intraoral tissues to fluoresce or return or reflect light in another wavelength range in a detectable manner.
Target Area
Intraoral soft tissues.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.6350
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.6350 Ultraviolet detector

§ 872.6350 Ultraviolet detector.

(a) Identification. An ultraviolet detector is a device intended to provide a source of ultraviolet light which is used to identify otherwise invisible material, such as dental plaque, present in or on teeth.

(b) Classification. Class II.

Diagnostic Light, Soft Tissue Detector

Page Type
Product Code
Definition
To be used as an aid in the detection or visualization of abnormalities of intraoral soft tissue. An adjunct to traditional intraoral examination by incandescent light to enhance the visualization of oral mucosal abnormalities
Physical State
The device consists of a light source with light guide cable or a handpiece based light emitting apparatus. Added components may or may not block or filter out light inundesired frequencies. The reflected light reveals tissue characteristics that are abnormal, or are suspected to be abnormal.
Technical Method
The device emits a light in a specific wavelength range causing intraoral tissues to fluoresce or return or reflect light in another wavelength range in a detectable manner.
Target Area
Intraoral soft tissues.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.6350
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.6350 Ultraviolet detector

§ 872.6350 Ultraviolet detector.

(a) Identification. An ultraviolet detector is a device intended to provide a source of ultraviolet light which is used to identify otherwise invisible material, such as dental plaque, present in or on teeth.

(b) Classification. Class II.