Product Code: QNF FDA class 2 21 CFR 872.6070

Laser Activator For Polymerization

Dental

The Laser Activator for Polymerization is a dental device intended to polymerize dental restorative resins using laser energy, providing an alternative to conventional light-curing units for hardening composite materials in dental restorations. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 872.6070 in the Dental specialty. It carries product code QNF and is not an implant and not life-sustaining.

510(k)s
2
FEI Numbers
3
Registration Numbers
3
Unique Applicants
2
Years Active
3

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Basic Information

Product Code
QNF
Device Class
FDA class 2
Regulation Number
872.6070
Medical Specialty
Dental
Review Panel
DE
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

Definition

Intended to polymerize dental restorative resins

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K232076 Fibercure
K201904 Monet Curing Laser

FEI Numbers

This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.