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510(k) Data Aggregation
K Number
K111828Device Name
CLEARSPLINT ES
Manufacturer
ASTRON DENTAL CORPORATION
Date Cleared
2011-10-26
(120 days)
Product Code
MQC, MOC
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ASTRON DENTAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Clearsplint ES is a heat cured, moldable, acrylic compound for use in the fabrication of dental appliances and dental prostheses devices including TMJ splint appliances, night guards, bruxism appliances and other devices as prescribed.
Device Description
Clearsplint ES is a heat cured, moldable, acrylic compound.
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