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510(k) Data Aggregation
K Number
K223507Device Name
CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE)
Manufacturer
Good Doctors Co., Ltd.
Date Cleared
2023-08-04
(255 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
Good Doctors Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CL-DP40 (Dr's Light PRIME)/CL-DP40 (Dr's Light CHOICE)is a hand held LED polymerization light intended to cure dental composites using visible light.
Device Description
This unit is a battery type wireless LED curing light. User can adjust light intensity and time by selecting six program modes. Both of Dr's Light PRIME and Dr's Light Choice are characterized by high power intensity, slim head height, large irradiation area (12mm), adjustable intensity power, highly readable color touch screen, 360° twistable head and big capacity of the battery.
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K Number
K151274Device Name
Dr's Finder
Manufacturer
GOOD DOCTORS CO., LTD.
Date Cleared
2016-02-04
(267 days)
Product Code
LQY, LOY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
GOOD DOCTORS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dr's Finder is intended for detecting the apex of root canal.
Device Description
The device allows the relative position of a dental file and the apex to be determined electrically. Using a standard dental file inserted into the root canal as an electrode, the device emits very small electrical currents having frequencies of 400 Hz, and 10400 Hz. The current between the file and mouth is measured at each of these frequencies, and the readout of the relative proximity to the apex will appear on the meter.
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K Number
K093751Device Name
CL-DC20, CL-DC21
Manufacturer
GOOD DOCTORS CO., LTD.
Date Cleared
2010-02-24
(79 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
GOOD DOCTORS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CL-DC20 and CL-DC21 Dental Curing Lights are indicated for the curing of dental composites using visible light.
Device Description
Not Found
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K Number
K071908Device Name
DOCTOR'S LIGHT LED DENTAL CURING LIGHT
Manufacturer
GOOD DOCTORS CO., LTD.
Date Cleared
2007-08-23
(44 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
GOOD DOCTORS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Curing of dental composites using visible light.
Device Description
Doctor's Light LED Dental Curing Light is a hand-held polymerization light intended for use in curing dental composites. This product uses a rechargeable Li-ion Battery for cordless operation.
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