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Found 5 results
510(k) Data Aggregation
K Number
K022803Device Name
WATERLASE FOR APICOECTOMY
Manufacturer
BIOLASE TECHNOLOGY, INC.
Date Cleared
2003-02-03
(164 days)
Product Code
MXF
Regulation Number
872.4120Why did this record match?
Product Code :
MXF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K013908Device Name
WATERLASE MILLENNIUM
Manufacturer
BIOLASE TECHNOLOGY, INC.
Date Cleared
2002-02-12
(78 days)
Product Code
MXF
Regulation Number
872.4120Why did this record match?
Product Code :
MXF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Class I, II, III, IV and V cavity preparation.
Caries removal.
Hard tissue surface roughening or etching.
Enameloplasty, excavation of pits and fissures for placement of sealants.
Cutting, shaving, contouring and resection of oral osseous tissues (bone).
Device Description
The Waterlase™ Millennium® hydrokinetic tissue cutting system is a diverse instrument for performing several dental applications. Waterlase™ Millennium® utilizes advanced laser and water atomization technologies to incise, excise and ablate intraoral soft and hard tissues safely and effectively. An erbium, chromium, yttrium, scandium, gallium garnet (Er, Cr.YSGG) solid state laser provides optical energy to a user controlled distribution of atomized water droplets. As the water droplets absorb the optical energy hydrokinetic cutting effects result. The hydrokinetic process refers to the removal of tissues with laser energized water particles. Strong absorption of laser energy by atomized water droplets results in an intense yet controlled water particle micro-expansion and acceleration. The resulting hydrokinetic forces induce mechanical separation of surface material, yielding quick and clean mechanical tissue removal. A flexible fiberoptic handpiece delivers the Waterlase™ Millennium's® unique hydrokinetic tissue cutting technology. A visible light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output and atomized water spray distribution may be adjusted to specific user requirements.
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K Number
K012511Device Name
WATERLASE MILLENNIUM
Manufacturer
BIOLASE TECHNOLOGY, INC.
Date Cleared
2002-01-18
(165 days)
Product Code
MXF
Regulation Number
872.4120Why did this record match?
Product Code :
MXF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tooth preparation to obtain access to the root canal Pulpotomy Pulp extirpation Pulpotomy as an adjunct to root canal therapy Root canal debridement and cleaning Root canal preparation including enlargement
Device Description
The Waterlase Millennium dental laser system may be used to perform several dental applications. For hard tissue procedures the Waterlase Millennium utilizes the Erbium, Chromium: Yttrium, Scandium, Gallium, Garnet (Er,Cr:YSGG) laser in combination with advanced water atomization technology to cut, remove, roughen and etch tissues. Soft tissue procedures are performed using a different mode of operation where direct Er,Cr.YSGG laser energy is applied to incise, excise or ablate the tissues. In soft tissue procedures the water spray is applied for hydration, cooling or to keep tissues clean. A flexible fiberoptic handpiece delivers the Waterlase Millennium laser energy. A visible light emitted from the handpiece distal end pinpoints the area of treatment. In both hard and soft tissue applications the power output, pulse energy, repetition rate and air and water flow rates are adjustable to specific user requirements.
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K Number
K990908Device Name
MILLENNIUM
Manufacturer
ENDO TECHNIC CORP.
Date Cleared
1999-05-27
(70 days)
Product Code
MXF
Regulation Number
872.4120Why did this record match?
Product Code :
MXF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use on adult and pediatric patients for the following:
Class I, II, III, IV and V cavity preparation
Caries removal
Hard tissue surface roughening or etching
Enameloplasty, excavation of pits and fissures for placement of sealants
Device Description
The Millennium™ hydrokinetic tissue cutting system is a diverse instrument for performing several dental applications. Millennium™ utilizes advanced laser and water atomization technologies to incise, excise and ablate intraoral soft and hard tissues safely and effectively. An erbium, chromium, yttrium, scandium, gallium garnet (Er, Cr:YSGG) solid state laser provides optical energy to a user controlled distribution of atomized water droplets. As the water droplets absorb the optical energy hydrokinetic cutting effects result.
The hydrokinetic process refers to the removal of tissues with high speed, atomized water particles. Strong absorption of laser energy by atomized water droplets results in an intense yet controlled water particle micro-expansion and acceleration. The resulting hydrokinetic forces induce mechanical separation of surface material, vielding quick and clean mechanical tissue removal.
A flexible fiberoptic handpiece delivers the Millennium™s unique hydrokinetic tissue cutting technology. A visible light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output and atomized water spray distribution may be adjusted to specific user requirements.
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K Number
K990219Device Name
MODIFICATION OF MILLENNIUM
Manufacturer
BIOLASE TECHNOLOGY, INC.
Date Cleared
1999-02-24
(33 days)
Product Code
MXF
Regulation Number
872.4120Why did this record match?
Product Code :
MXF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Class I - V cavity preparation
Caries removal
Hard tissue surface roughening or etching
Device Description
The Millennium™ hydrokinetic tissuc cutting system is a diverse instrument for Pine Millennium - Hydrokins. Millennium™ utilizes advanced laser and performing coverer. comologies to incise, excise and ablate intraoral soft and hard water alonitation totatively. An erbium, chromium, yttrium, scandium, gallium gamet (Er, Cr.YSGG) solid state laser provides optical energy to a user controlled distribution of atomized water droplets. As the water droplets absorb the optical energy hydrokinetic cutting effects result.
The hydrokinetic process refers to the removal of tissues with high speed, atomized water particles. Strong absorption of laser energy by atomized water droplets results in an intense yet controlled water particle micro-expansion and acceleration. The resulting hydrokinetic forces induce mechanical separation of surface material, yielding quick and clean mechanical tissue removal.
A flexible fiberoptic handpiece delivers the Millennium™s unique hydrokinetic tissue cutting technology. A visible light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output and atomized water spray distribution may be adjusted to specific user requirements.
Ask a Question
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