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Found 7 results
510(k) Data Aggregation
K Number
K182017Device Name
Compex HD
Manufacturer
AdDent, Inc.
Date Cleared
2019-04-29
(276 days)
Product Code
QGO, EBZ, EEG, OGO
Regulation Number
872.6100Why did this record match?
Applicant Name (Manufacturer) :
AdDent, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Compex HD is intended to be used by a dentist or health care provider to warm and dispense dental composite materials contained in a compule or PLT (Pre Loaded Tip) to 155 degrees F (68 degrees C).
Device Description
The Compex HD uses a heating device to elevate the temperature of dental composite material contained in a compule (PLT) to allow it to flow and be easily extruded. It utilizes a plastic housing in the shape of a traditional dispensing qun. The housing contains a heater element(s) and/or an electrically conductive plastic compule that itself acts as a heater when a current is applied. A control circuit board assembly and rechargeable lithium lon battery are used to apply power to the heater. A separate wall plug-in USB power supply is used to charge the battery. The unit will not function with the USB power supply connected to the unit.
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K Number
K121282Device Name
MICROLUX/DL MICROLUX/BLU BIO/SCREEN
Manufacturer
ADDENT, INC.
Date Cleared
2012-07-24
(85 days)
Product Code
NXV
Regulation Number
872.6350Why did this record match?
Applicant Name (Manufacturer) :
ADDENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ORABLU Oral Lesion Marking System is a three component swab system intended to be used by a dentist as an adjunct to traditional oral examination by incandescent light, combined with further examination with one of three oral examination lights manufactured by AdDent, Inc. The Microlux DL (K041614), Microlux BLU (K072309), and Bio/Screen (K082668). The ORABLU Oral Lesion Marking System is used as an aid to enhance the visualization of oral mucosal irregularities by physically marking areas of oral mucosa that may warrant further investigation.
Device Description
The ORABLU Oral Lesion Marking System is a three component swab system.
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K Number
K082668Device Name
BIO-SCREEN
Manufacturer
ADDENT, INC.
Date Cleared
2009-01-23
(133 days)
Product Code
NXV
Regulation Number
872.6350Why did this record match?
Applicant Name (Manufacturer) :
ADDENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bio-Screen is intended to be used by a dentist or health care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities and aid in defining lesion borders
Device Description
This device uses an array of short wave blue LED's in the technique of biofluorescence to demonstrate abnormal oral tissue It employs a built in optical filter to improve contrast between healthy and abnormal tissue and improve visualization
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K Number
K072309Device Name
MICROLUX/BLU
Manufacturer
ADDENT, INC.
Date Cleared
2007-11-19
(94 days)
Product Code
EAZ
Regulation Number
872.4630Why did this record match?
Applicant Name (Manufacturer) :
ADDENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K062961Device Name
MICROLUX TRANSILLUMINATOR
Manufacturer
ADDENT, INC.
Date Cleared
2007-02-08
(132 days)
Product Code
NTK
Regulation Number
872.1745Why did this record match?
Applicant Name (Manufacturer) :
ADDENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Microlux Transilluminator is a device used upon initial examination of the dental patient to help locate crown fractures, posterior and anterior caries.
The Microlux Transilluminator is a screening device used to help locate caries and crown fractures. It also functions as an auxiliary light source to aid in operative procedures and preventive dentistry.
Device Description
The Microlux Transilluminator consists of a battery powered, high output L.E.D. light source, (three 'N" size batteries are included) and a fiber-optic glass light guide with either a 3mm or 2mm tip. The fiber-optic glass light guide snaps into the light source. The fiber-optic light guide is autoclaveable. The light source can be wiped with disinfectant. Disposable custom fitted sleeves are also available the cover the entire unit to prevent cross contamination.
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K Number
K061395Device Name
CALSET COMPOSITE HEATER
Manufacturer
ADDENT, INC.
Date Cleared
2006-06-23
(35 days)
Product Code
EBZ, EEG, EFC
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
ADDENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended Use: The Calset unit is used to warm dental composite materials and whitening bleach to130°F (54°C) or 155°F (68°C). It is also used to warm anesthetic carpules to 98°F (37°C) (body temperature).
Device Description
The Calset is a warming device used to heat dental materials prior to their use in the mouth. It consists of a base unit that contains a heating element a temperature control circuit with LED indicators, a removable metal tray that is designed to hold different materials and a low voltage wall transformer that provides power to the unit.
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K Number
K041614Device Name
MICROLUX DL
Manufacturer
ADDENT, INC.
Date Cleared
2005-04-04
(293 days)
Product Code
EAZ
Regulation Number
872.4630Why did this record match?
Applicant Name (Manufacturer) :
ADDENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is used as an aid to improve the visualization of oral lesions. It is designed to be used by a dentist or health care provider, in combination with a traditional examination by incandescent light.
Device Description
The Microlux/DL is used to enhance dental examination of lesions of the oral mucosa. The device consists of a battery powered light source that uses a blue-white LED, a rigid diffused fiber optic light guide. It is used in conjunction with a non-toxic dilute (1%) acetic acid rinse for the viewing of oral lesions. The fiber optic illuminator itself is non-tissue contacting, and is classified as a 510(k) Exempt FDA Device.
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