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510(k) Data Aggregation
K Number
K121365Device Name
THERMOFORMED MOUTHGUARDS
Manufacturer
GLIDEWELL LABORATORIES-SLEEP DEVICES GROUP
Date Cleared
2012-11-20
(197 days)
Product Code
MQC, MOC
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
GLIDEWELL LABORATORIES-SLEEP DEVICES GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Thermoformed Mouthguards are intended for protection against bruxism and nighttime teeth grinding. They create a barrier between the upper and lower dentition to protect the patient's overall occlusion.
Device Description
The Thermoformed Mouthguards/Nightguards are designed to alleviate the pain and damage caused by bruxing or clenching of the teeth. These customized devices fit over upper or lower teeth during sleep and can offset the effects of bruxing or clenching while protecting teeth from daily wear and tear. The design of Thermoforming Mouthguards/Nightguards is the same, and the only difference is the material in terms of hardness, softness or semi-softness. Each Mouthguard/Nightguard is made with a standard flat occulusal plane and slight opposing cusp indentation to each patient's specific bite plane needs that could be determined by a dentist after diagnosis of bruxism. The Comfort H/STM Hard Soft Bite Splint is the most widely prescribed bite splint due to its comfort and fit. The soft internal surface rests comfortably against the teeth and gums, while the hard occlusal surface provides durability and bonds. Thermoformed Mouthguards/Nightguards are manufactured from biocompatible materials.
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K Number
K060104Device Name
PRISMATIK CLINICAL ZIRCONIA
Manufacturer
GLIDEWELL LABORATORIES
Date Cleared
2006-03-15
(61 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
GLIDEWELL LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior locations.
For use in prosthetic dentistry to create porcelain (ceramic) prostheses.
For use only by or on the order of a dental professional such as a DDS or DMD. Not for use by the general public or OTC.
Device Description
The device is comprised primarily of of dental porcelain zirconium oxide powder that is used in the form of blanks as a part of dental laboratory processes that are used to fabricate all ceramic dental restorations, reinforced with a hard ceramic core, that are custom fitted to conform precisely to patients' models.
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K Number
K050144Device Name
PRISMATIK CERAMIC
Manufacturer
GLIDEWELL LABORATORIES
Date Cleared
2005-03-03
(38 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
GLIDEWELL LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is indicated for use by dental technicians in the construction of custom porcelain (ceramic) and porcelain (fused to metal) dental restorations for anterior and posterior locations.
For use in prosthetic dentistry to create porcelain (ceramic) and porcelain (fused-to-metal) prostheses.
Device Description
The device is comprised of dental porcelain powder that is used in the form of powder or blanks as a part of dental laboratory processes that are used to fabricate porcelain (ceramic) and porcelain (fused-to-metal) dental devices that are custom fitted to conform precisely to patients' models.
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K Number
K972424Device Name
SILENTNITE
Manufacturer
GLIDEWELL LABORATORIES
Date Cleared
1997-09-18
(83 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
GLIDEWELL LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SilentNite™ mandibular repositioning (MRP) device is indicated for persons who wish to prevent snoring and is available only from a dentist by prescription. It has been estimated that 6 million or more adults (with men outnumbering women 8 to 1) snores, and that 10% may have sleep apnea. If an examination of the patient, together with the patient's responses to a questionnaire, indicate the possibility of a more serious sleep disorder than "primary" or "social" snoring, the patient should be referred to a physician who can diagnose sleep apnea based on testing in a sleep laboratory and suggest treatment options. Necessary treatment for serious cases of sleep apnea may include surgery, or a medically prescribed treatment called nasal continuous positive airway pressure, or a MRP device. MRP devices may be appropriate treatment for persons with mild sleep apnea when surgical and other medical treatments are ineffective or not desired. Contraindications for use: Based on the dentists examination and the patient's responses the questionnaire, obstructive sleep apnea may either be indicated or cannot be excluded. In such event, an examination by a sleep disorder specialist is recommended before prescribing the SilentNite™ snoring device. If the dentist's examination and the patient's responses to the questionnaire indicate the possibility of disease or injury to the mandibular joint, the SilentNite™ snoring device is contraindicated and should not be prescribed, to avoid the possibility of further damage to the mandibular joint.
Device Description
The SilentNite™ device is comprised of upper and lower frames that are attached with connectors. The frames are form fitted to the teeth and are meant to be worn at night while sleeping.
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