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Found 12 results
510(k) Data Aggregation
K Number
K100785Device Name
BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES
Manufacturer
BONART CO. LTD.
Date Cleared
2010-12-03
(259 days)
Product Code
EBW
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
BONART CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ART-IM1 Implantor is an implant machine system. It is primarily used by dental professionals in doing oral implant surgery or implantology such as drilling, reaming, cutting, etc. This system is also used for fixing previous broken or failed implant procedure.
Device Description
BonartART-IM1 Implantor System & Accessories
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K Number
K082971Device Name
BONART ART-L5 LED CORDLESS CURING LIGHT
Manufacturer
BONART CO. LTD.
Date Cleared
2008-11-13
(38 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
BONART CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ART-L5 LED Cordless Curing Light System is used in light polymerization of dental composite and curing dental restorative thru source of illuminations.
Device Description
Not Found
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K Number
K081550Device Name
BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO
Manufacturer
BONART CO. LTD.
Date Cleared
2008-08-28
(86 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
BONART CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ART-P31! Pro Multi-function piezoelectric Ultrasonic system is intended for use by medical professionals during denral cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a stainless steel t p dental accessory called "Tip". Tip comes in various shapes (BS1, BS2, B53 etc.) and is designed to generate a vibrating frequency of 29Khz.
ART-M311 Pro Multi-function-Magnet Ultrasonic System is intended for use by medical professionals during demal cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a stainless steel tip dental accessory called "Insert comes in various shapes (ART P-10, ART SLI-P100, ART IF50 etc.) and is designed to generate a vibrating frequency of 24.5KHz. ±5%.
Device Description
Not Found
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K Number
K080761Device Name
BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES
Manufacturer
BONART CO. LTD.
Date Cleared
2008-08-25
(160 days)
Product Code
DZI
Regulation Number
872.4120Why did this record match?
Applicant Name (Manufacturer) :
BONART CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ARTeotomy Ultrasonic surgery system (OP1) uses piezoelectric ultrasonic technology to generate mechanical micro vibrations for bone cutting, with minimal soft tissue trauma. The system is supplied with sharp, smoothing and blunt insert tips for dental oral surgery use, including implantology, periodontal surgery and surgical orthodontics. Piezo tips come in various shapes and forms (BS-OTI, BS-OT3, BS-OT5 etc.) and are designed to generate a vibrating frequency of 26-32 kHz
The ARTeotomy Ultrasonic Surgery System (OM1) uses magnetostrictive ultrasonic technology to generate mechanical micro vibrations for bone cutting, with minimal trauma to soft tissue. The system is supplied with sharp, smoothing and blunt insert for dental oral surgery use, including implantology, periodontal surgery and surgical orthodontics. Inserts come in various shapes and forms (ART-AS, ART-LH, ART-LV etc.) and are designed to generate a vibrating frequency of 24.5 kHz.
Device Description
Not Found
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K Number
K071981Device Name
BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS)
Manufacturer
BONART CO. LTD.
Date Cleared
2007-10-26
(100 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
BONART CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ART-P6 Piczo Electric Ultrasonic Scaler is intended for use by medical professionals during dental cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a stainless steel tip dental accessory called "Tip". Tip comes in various shapes (BS1, BS2, BS3 etc.) and is designed to generate a vibrating frequency of 29Khz,
Device Description
BONART ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS)
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K Number
K062289Device Name
BONART ART-L3 LED CURING LIGHT
Manufacturer
BONART CO. LTD.
Date Cleared
2007-01-03
(149 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
BONART CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Source of illumination for curing dental is restorative materials.
Device Description
BONART ART-L3 LED CURING LIGHT
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K Number
K061448Device Name
BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES
Manufacturer
BONART CO. LTD.
Date Cleared
2006-08-17
(87 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
BONART CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BONART's ART-P3II & ART-P4 Piezo Ultrasonic Scaler are intended for use by medical professionals during dental cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a stainless steel tip dental accessory called "Tip". Tips come in various shapes (BS1, BS2, BS3 etc.) and are designed to generate a vibrating frequency of 29Khz.
Device Description
BONART ART-P3II PIEZO ULTRASONIC SCALER & ACCESSORIES (TIPS) BONART ART-P4 PIEZO ULTRASONIC SCALER & ACCESSORIES (TIPS)
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K Number
K052028Device Name
BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS)
Manufacturer
BONART CO. LTD.
Date Cleared
2005-10-28
(93 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
BONART CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K023721Device Name
BONART ART-L2 LIGHT CURING UNIT
Manufacturer
BONART CO. LTD.
Date Cleared
2003-01-10
(66 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
BONART CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ART-L2 uses the optical characteristics of the light to generate radial spectrum of the bulb to go through the optical lens and produce appropriate radial light power density via optical fiber and projected on the mixed resin of dentistry filling substances special filling material to achieve tooth filling effect.
Device Description
ART-L2 LIGHT CURING UNIT
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K Number
K000510Device Name
ART-M1, MODEL M1-1-ART-A1
Manufacturer
BONART CO. LTD.
Date Cleared
2000-05-15
(90 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
BONART CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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