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510(k) Data Aggregation
K Number
K230495Device Name
Serena Sleep Night Guard
Manufacturer
Meris Investment Group
Date Cleared
2023-10-13
(232 days)
Product Code
MQC, OCO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Meris Investment Group
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Serena Sleep Night Guard/Occlusal Appliance is a removable medical device that is fitted to the patient's mouth and is intended to protect teeth and restorations against the forces of bruxism and alleviate temporomandibular joint, jaw, and muscle and tension headache pains.
Device Description
The Serena Sleep Night Guard/Occlusal Appliance is a custom-made intraoral device used for protecting teeth and restorations against the forces of bruxism and alleviating temporomandibular joint, jaw, and muscle and tension headache pains.
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K Number
K203606Device Name
Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)
Manufacturer
Meris Investment Group
Date Cleared
2021-03-10
(90 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Meris Investment Group
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Serena Sleep Appliance is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Device Description
The Serena Sleep Block Mandibular Advancement is an intraoral device that treats snoring and sleep apnea through mandibular repositioning the lower jaw forward from its normal location, the patient's pharyngeal space is increased and their ability to exchange air during sleep is improved. This device consists of custom fitted trays which fit over the upper and lower teeth. Based on the physician's prescription, positioning blocks are built into the upper and lower trays The mandibular advancement is achieved through the physician's selection of a specific upper and lower tray that when fitted, sets the optimal mandibular advancement. The separate two-piece construction is desirable for patients that want greater range of motion and lateral movement.
The Elastic Mandibular Advancement model is similar to the Block Mandibular Advancement but has exterior pins that allow for the use of rubber bands rather than the blocks. These bands provide additional treatment options and forces for repositioning the bottom jaw.
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