Laser Activator For Polymerization
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.
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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
Definition
Intended to polymerize dental restorative resins
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
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.