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Laser Activator For Polymerization

Page Type
Product Code
Definition
Intended to polymerize dental restorative resins
Physical State
Handheld device including a light guide, a rechargeable battery, a charging station and barrier sleeve and eye protection accessories
Technical Method
Laser energy, in the form of coherent light, is directed by means of optical focusing lenses to cure photoactivated dental restorative resins
Target Area
Used intraorally on resin restorative surfaces
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.6070
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.6070 Ultraviolet activator for polymerization

§ 872.6070 Ultraviolet activator for polymerization.

(a) Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.

(b) Classification. Class II.

Laser Activator For Polymerization

Page Type
Product Code
Definition
Intended to polymerize dental restorative resins
Physical State
Handheld device including a light guide, a rechargeable battery, a charging station and barrier sleeve and eye protection accessories
Technical Method
Laser energy, in the form of coherent light, is directed by means of optical focusing lenses to cure photoactivated dental restorative resins
Target Area
Used intraorally on resin restorative surfaces
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.6070
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.6070 Ultraviolet activator for polymerization

§ 872.6070 Ultraviolet activator for polymerization.

(a) Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.

(b) Classification. Class II.