Search Results
Found 12 results
510(k) Data Aggregation
K Number
K033392Device Name
IMMEDIATE STABILIZING IMPLANT (ISI)
Manufacturer
O CO., INC.
Date Cleared
2003-12-10
(48 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
O CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Immediate Stabilizing Implant (ISI) is a one-piece threaded dental implant with the abutment incorporated into the design for a single stage surgical procedure. The implant is intended to be surgically placed in the bone of the upper or lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function. Immediate loading can be obtained if implants are rigidly splinted.
Device Description
Self-tapping one-piece CP Titanium threaded dental implant, with a roughened surface treatment. Available in 3.25mm, 4.0mm, and 5.0mm diameter, and in lengths of 8mm 10mm, 12mm, 14mm & 16mm.
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K Number
K021978Device Name
PETIT SOPHIA
Manufacturer
NISHITOMO CO., INC.
Date Cleared
2003-04-08
(295 days)
Product Code
LHD
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
NISHITOMO CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For measuring, and recording basal body temperature(BBT) as an aid in ovulation prediction to aid in conception (not to be used for contraception).
Device Description
This device is the clinical thermometer with memory the following functions.
(1) Alarm clock function for measuring temperature at constant time.
(2) Measuring accuracy within +/-0.05°C(between 35.00°C and 38.00°C) +/-0.1°C(between 34.00°C and 35.00°C, 38.00°C and 40.00°C)
(3) Displaying the measured temperature precisely, generating the measurement completion signal(buzz) and warning of a measuring error by buzzer, in case happened.
(4) Memory capacity of data for 6 menstrual cycles or 210 days.
(5) Displaying the measured temperature value in graph.
(6) Transferring the stored data to an external instrument.
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K Number
K023336Device Name
OCO DENTAL IMPLANT (5.0MM DIAMETER)
Manufacturer
O CO., INC.
Date Cleared
2002-10-09
(2 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
O CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"O" Company's OCO Endosseous Implant is intended to be surgically placed in the bone of the upper or lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function.
Device Description
OCO Dental Implant (5.0 mm Diameter)
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K Number
K021460Device Name
OCO DENTAL IMPLANT
Manufacturer
O CO., INC.
Date Cleared
2002-05-22
(15 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
O CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"0" Company's OCO Endosseous Implant is intended to be surgically placed in the bone of the upper or lower jaw surgically praced in the bone of the or still devices resulting arches providing bart the patient's chewing function.
Device Description
OCO Dental Implant (3.25mm diameter)
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K Number
K011524Device Name
IMMEDIATE STABILIZING DEVICE (ISD)
Manufacturer
O CO., INC.
Date Cleared
2002-04-10
(328 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
O CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K010142Device Name
OCO DENTAL IMPLANT
Manufacturer
O CO., INC.
Date Cleared
2001-02-01
(15 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
O CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K983776Device Name
EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP
Manufacturer
EVENFLO CO., INC.
Date Cleared
1999-04-26
(182 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
EVENFLO CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Evenflo Comfort Control Breast Pump and Comfort Control Dual Breast Pump are personal use battery/electric powered suction devices used to express milk from the breast of lactating women. These devices are not intended for hospital use.
Device Description
The Evenflo Comfort Control Adjustable Speed Breast Pump with Automatic Cycling, and the Evenflo Comfort Control Dual Adjustable Speed Breast Pump with Automatic Cycling are diaphragm type pumps, driven by small DC motors, that create cycling negative pressure. The negative pressure generated by the pump is sufficient to overcome the resistance to the outflow of milk that is created by the muscles, yet gentle enough to prevent tissue damage to the user. The cycling speed and the strength of the negative pressure are controlled by individual rotary controls located on the pump unit. The combination of cycling speed and negative pressure control allow for a range of pressures to be selected. When used as a single collection pump, the maximum negative pressure ranges from 173 mm Hg to 56 mm Hg, and when used in the dual mode, it ranges from 173 mm Hg to 43 mm Hg.
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K Number
K973926Device Name
O BUTMENT HS IMPLANT
Manufacturer
O CO., INC.
Date Cleared
1998-01-05
(82 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
O CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"O" Company's Titanium CP Endosseous Implant is intended to be surgically placed in the bone of the upper of lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function.
Device Description
A cylinder shaped commercially pure titanium dental implant with external threads and a Hydroxylapatite Coating.
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K Number
K960727Device Name
EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT
Manufacturer
EVENFLO CO., INC.
Date Cleared
1997-02-14
(358 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
EVENFLO CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K964320Device Name
TONY RISO 25/30 MULTIFUNCTION SCALER
Manufacturer
TONY RISO CO., INC.
Date Cleared
1997-01-23
(86 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
TONY RISO CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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