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510(k) Data Aggregation
K Number
K121272Device Name
PROTECH DENT
Manufacturer
AKERVALL TECHNOLOGIES INC
Date Cleared
2012-10-15
(171 days)
Product Code
OBR
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
AKERVALL TECHNOLOGIES INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Akervall Technologies mouthguards (ProTech Dent,) are indicated for use in protecting the teeth and reduce damage caused by bruxism or nighttime grinding.
Device Description
The ProTech Dent guard consists of a polycaprolactone based polymer with a tensile strength significantly higher than EVA( 29.11 MPa versus 22.3 MPa). It comes in a pre-shaped form (1.6 mm thick). The form softens when heated in hot water and can then easily be custom fit to the user's teeth. When the user sucks on the mouth guard it shapes around the teeth with no or minimal space between the material and the teeth. The polymer hardens in about 30 seconds and is then durable so that it does not deform when impacted with forces typically encountered in the mouth.
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