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510(k) Data Aggregation
K Number
K232076Device Name
Fibercure
Manufacturer
Lumendo AG
Date Cleared
2023-11-02
(112 days)
Product Code
QNF
Regulation Number
872.6070Why did this record match?
Product Code :
QNF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For light curing polymerization of small areas of dental materials capable of curing in the 385 – 425 nm wavelength range.
Device Description
Fibercure is a handheld dental curing light intended for light curing polymerization of small areas of dental materials capable of curing in the 385 – 425 nm wavelength range. Fibercure functions by delivering light energy to photocurable dental materials, which utilize the light energy to induce a photopolymerization reaction.
Fibercure consists of a pen-shaped handpiece, that is powered with a detachable, rechargeable battery. The handpiece features a user interface containing two push buttons and three status LEDs. The hand-piece is equipped with a solid-state laser diode to generate light energy at a wavelength of 405 ± 5mm and a power of 40 mW. The laser diode is coupled to single-use cure tips containing an optical fiber of 200 µm diameter. The cure tip emits light with an irradiance of 1800 - 2200 mW/cm2 and allows the light to be precisely targeted on the area to be photocured. Fibercure has 2 operation modes to provide either 10 or 20 second irradiation. Fibercure is delivered with a charging stand that is connected to the mains power using a USB power supply. It provides two charging stations and a photometer to confirm the intensity of the emitted light.
Fibercure's handpiece is manufactured from anodized aluminum and houses the electronic assembly. The cure tip consists of a silica-ETFE optical fiber, a stainless-steel fiber guide, a plastic housing and a ceramic ferrule. The detachable battery, charging base and power supply are manufactured from injection-molded plastic.
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K Number
K201904Device Name
Monet Curing Laser
Manufacturer
CAO Group, Inc.
Date Cleared
2020-11-24
(138 days)
Product Code
QNF, EBZ, GEX
Regulation Number
872.6070Why did this record match?
Product Code :
QNF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Monet Curing Laser is a source of illumination for curing photo-active materials and adhesives.
Device Description
The Monet Curing Laser is a device for delivering light energy to dental restorative materials and adhesives, which utilize the light energy to affect a photopolymerization reaction. This energy is generated by a solid-state laser diode, which provides a consistent and reliable generation of laser energy at 450 ± 5nm for a maximum of 2.0 watts (2400 mW/cm²) of energy output. The laser energy is delivered to the dental material by means of an optical focusing lens that collimates the laser energy to a nearly parallel beam size that remains highly consistent regardless of distance to the target material. The device also includes a low-intensity aiming beam feature that allows the operator to see the delivery site of the energy without risk of premature polymerization of the material. The device features a metal construction with glass output window that contains all device electronics. The device features a simple on/off switch and set 3-second activation time. The device incorporates a detachable rechargeable battery which is recharged on an accompanying charging stand. The charging stand incorporates a basic radiometer to allow the user to confirm the output intensity of the emitted light.
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