Search Results
Found 3 results
510(k) Data Aggregation
K Number
K170822Device Name
Electronic Caries Detector
Manufacturer
Ortek Therapeutics, Inc.
Date Cleared
2017-09-11
(175 days)
Product Code
NBL, LFC
Regulation Number
872.1745Why did this record match?
Applicant Name (Manufacturer) :
Ortek Therapeutics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Electronic Caries Detector is for use by dental professionals as an aid in the diagnosis and monitoring of dental caries.
Device Description
The ECD is a portable instrument that provides an electrical current source, a meter with a digital read-out between 00 and 100, and indicator and reference electrodes to aid in the detection and monitoring of non-cavitated and cavitated caries lesions in teeth.
The ECD indicator electrode is comprised of a replaceable, single-use, stainless steel probe tip. This component is sized and dimensionally configured to achieve close contact with the tooth being examined. The tip ensures electrical contact with dentinal fluid at sites that are not readily accessible or evaluated using traditional means. The ECD indicator electrode is paired with a reference electrode to complete the necessary electrical circuit. The reference electrode is a stainless steel lip hook that rests on the patient's lower lip.
The device is powered by a 9 volt alkaline battery, regulated down to 5 volts. The unit has a 2 ½ digit LCD display, two timer circuits, and a beeper. The first timing circuit is triggered upon circuit completion. The beeper sounds for 3 seconds, the probe is then removed, and the second timer holds the display for 5 seconds. Then the display returns to zero, ready for the next measurement.
Ask a Question
K Number
K003482Device Name
PROCLUDE-SENSITIVE
Manufacturer
ORTEK THERAPEUTICS, INC.
Date Cleared
2001-02-01
(84 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
ORTEK THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K002989Device Name
PROCLUDE
Manufacturer
ORTEK THERAPEUTICS, INC.
Date Cleared
2000-12-14
(80 days)
Product Code
EJR
Regulation Number
872.6030Why did this record match?
Applicant Name (Manufacturer) :
ORTEK THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1