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Found 17 results
510(k) Data Aggregation
K Number
K202855Device Name
Orthodontic Facemask
Manufacturer
ITA.O Italian Orthodontic System S.r.l.
Date Cleared
2021-06-21
(266 days)
Product Code
DZB
Regulation Number
872.5500Why did this record match?
Product Code :
DZB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Orthodontic Facemask is used as a treatment option for Class III malocclusions.
Device Description
Not Found
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K Number
K162543Device Name
Reverse Pull Adjustable Facemask
Manufacturer
SAWBROS INDUSTRIES PVT.LTD.
Date Cleared
2017-08-28
(350 days)
Product Code
DZB
Regulation Number
872.5500Why did this record match?
Product Code :
DZB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Use as a treatment option for Class III malocclusion.
Device Description
The Reverse Pull Adjustable Facemask is an extra oral device placed on the face of a patient. The subject device is provided assembled; packaged in a plastic heat sealed bag placed in a nylon pouch, to safeguard the integrity of the packaging. The device is provided non(sterile. No prior skin preparation is required to use the device. The skin contacting surfaces may require light cleaning with water between uses, depending on the patient's personal hygiene.
The subject device consists of a vertical main frame, made of 304(grade stainless steel, having adjustable supports for the patient's forehead and chin. The two supports are lined with Ethylene( Vinyl Acetate (EVA) plastic foam for patient comfort. Moreover, the forehead support has two vents to allow airflow to skin in contact with the support. Two additional EVA pads for forehead and chin supports are included for patient comfort and hygiene.
An elastic capstan crossbar made of 304 grade stainless steel, with an allen screw is present on the vertical main frame between the forehead and chin support. The crossbar is utilized by the Orthodontic practitioner as a means of anchorage support for attaching elastics to intraoral appliances. Elastics or the intraoral appliances are not provided with this device.
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K Number
K111169Device Name
PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF
Manufacturer
KWANG MYUNG DAICOM INC
Date Cleared
2011-10-03
(160 days)
Product Code
DZB
Regulation Number
872.5500Why did this record match?
Product Code :
DZB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Protraction Face Mask and Reverse Pull Face Mask are used as a treatment option for Class III malocclusions.
Device Description
Not Found
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K Number
K103019Device Name
KJ MASK
Manufacturer
KJ MEDITECH CO., LTD
Date Cleared
2011-06-09
(240 days)
Product Code
DZB
Regulation Number
872.5500Why did this record match?
Product Code :
DZB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KJ Mask is used as a treatment option for Class III malocclusions.
Device Description
KJ Mask (KM 102-S, KM 201-L) is a device made of materials such as aluminum alloy, stainless steel and plastic intended to be placed on face for the purpose of orthodontics. The device is constructed of four parts, a chip cup, forehead rest, cross bar and main frame. It is intended to exert orthopedic or orthodontic forces of the maxillary arch in order to effect a change in the position of the maxilla in relation to the mandible and other facial structures.
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K Number
K052553Device Name
NITOM LOCKING FACEBOW
Manufacturer
RUSSELL SAMUELS ORTHODONTIC DESIGN
Date Cleared
2005-12-22
(97 days)
Product Code
DZB
Regulation Number
872.5500Why did this record match?
Product Code :
DZB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitom Locking facebow is a type of orthodontic facebow used in Orthodontic treatment with a neckstrap or headcap to hold or move the upper back teeth backwards. It has two catches or locks on the inner bow to prevent it accidentally coming out at night.
Device Description
The Nitom Locking facebow is a type of orthodontic facebow used in Orthodontic treatment with a neckstrap or headcap to hold or move the upper back teeth backwards. The Nitom Facebow has two catches or locks on the inner bow to prevent it accidentally coming out at night. It is attached to extra oral traction tubes of the patients fixed orthodontic appliance on the upper first molars. It is usually worn by the patient in the evening and at night. It improves the anchorage of the upper back teeth. It is made of stainless steel.
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K Number
K051751Device Name
EQUA-PULL SAFETY RELEASE MODULE
Manufacturer
ORTHO TECHNOLOGY
Date Cleared
2005-07-22
(23 days)
Product Code
DZB
Regulation Number
872.5500Why did this record match?
Product Code :
DZB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Equa Pull Constant Force Headgear is a safety release module used during the wear of Orthodontic Head Gear products, connected to Orthodontic Face Bows. The module is designed to provide pull force for treatment at light (12 ounce) or heavy (24 ounce) levels, and a release point force (60-90 ounces) for patient safety. The devices are for Orthodontic Use Only, on the order of an Orthodontist.
Device Description
Equa Pull Constant Force Headgear is a safety release module used during the wear of Orthodontic Head Gear products, connected to Orthodontic Face Bows. The module is designed to provide pull force for treatment at light (12 ounce) or heavy (24 ounce) levels, and a release point force (60-90 ounces) for patient safety.
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K Number
K041718Device Name
KELES FACEMASK
Manufacturer
GREAT LAKES ORTHODONTICS, LTD.
Date Cleared
2004-10-15
(113 days)
Product Code
DZB
Regulation Number
872.5500Why did this record match?
Product Code :
DZB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Keles protraction face mask is used in the treatment of patients with Class III The Keles profitaction facc mask is used in the neationed maxilla. The facemask is especially useful in patients with an anterior bite tendency or condition.
Device Description
The Keles Facemask is an orthodontic headgear device. All components have been used in legally marketed devices or have been found to be safe for dental use.
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K Number
K032392Device Name
MORALES PROTRACTION FACEMASK
Manufacturer
ORTOSIM, S.A. DE C.V.
Date Cleared
2003-10-22
(79 days)
Product Code
DZB
Regulation Number
872.5500Why did this record match?
Product Code :
DZB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Morales Protraction Facemask is intended as an efficient extraoral appliance in moving skeletal Class III maxilla forward and stabilizing or retracting the mandible. It is also effective in closing space and correcting negative overjet.
Device Description
Not Found
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K Number
K000358Device Name
MULTI ADJUSTABLE FACE MASK
Manufacturer
ORTHO TECHNOLOGY
Date Cleared
2000-06-09
(126 days)
Product Code
DZB
Regulation Number
872.5500Why did this record match?
Product Code :
DZB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993224Device Name
T-GEAR, MODEL TG/400-700
Manufacturer
DONTECH PRODUCTS B.V.
Date Cleared
2000-02-11
(137 days)
Product Code
DZB
Regulation Number
872.5500Why did this record match?
Product Code :
DZB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The T-Gear is a cervical headgear traction appliance that delivers constant forces on the dentition of an orthodontic patient. This device is used to treat 'Overbite' and 'Overjet'.
Device Description
The T-Gear is a cervical headgear traction appliance that delivers constant forces on the dentition of an orthodontic patient.
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