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510(k) Data Aggregation
K Number
K992236Device Name
LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA
Manufacturer
Date Cleared
1999-08-27
(56 days)
Product Code
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
LYSTA A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- Polymerization of light-cured dental materials
- Polymerization of restorative composite materials
Device Description
LCxx00 Compacta lamp is a polymerization lamp which provides light primarily in the range between 400 - 515 nm and is capable of curing light-cured dental materials. It is a component intended for integration in a standard dental unit and the light source is supplied with power from the unit. Compressed air for cooling of the handpiece is also provided from the unit.
The LCxx00 Compacta lamp is supplied with a 25 Watt, 40W, 60W or 80W halogen bulb. The visible light from the bulb is filtered to provide a wavelength between 400 and 515 nm which is directed to a light guide with an 8mm diameter. Light in this wavelength range is able to cure light composit material used for dental fillings.
The output from the LCxx00 Compacta through the autoclayable, detachable light guide is approximately 530 mW/cm² , 750 mW/cm² , 1080 mW/cm², 1440 mW/cm2 respectively, in total. Within the range of 400 - 515 nm the lamp has an output of approx. 390 mWlcm², 590 mW/cm2 , 825 mW/cm2 , 1180 mW/cm2 respectively. These measurements are carried out according to requirements in ISO/DIS 10650.2.
This light cures the restorative composite materials to a depth of about 5.5 mm, 5.7 mm, 6.0 mm, 6.7 mm respectively in 40 seconds. The composite is cured 100 % to a depth of 2.4 mm, 2.5 mm, 2.7mm and 3.1 mm respectively.
The halogen bulb is built into a handpiece which is ergonomically shaped so that it is comfortable and easy to use for a dentist. The housing of the handpiece is made of thermoplastic material. Excessive heat is cooled by air from the dental unit and if the cooling air should fail, a built in thermal fuse and a thermal switch will disconnect the electrical connection.
The LCxx00 Compacta is supplied with power and with air from the dental unit via a cable. This cable has a connector so that it is detachable from the handpiece.
The handpiece contains a bayonet-like connector which enables the front section to be detached from the rear section so that the halogen bulb and the light filter can be exchanged by the user.
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K Number
K991138Device Name
LYSTA LC CURING LIGHT, MODEL LC 2500C/BA
Manufacturer
Date Cleared
1999-04-23
(18 days)
Product Code
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
LYSTA A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- Polymerization of light-cured dental materials
- Polymerization of restorative composite materials
Device Description
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