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510(k) Data Aggregation
K Number
K061735Device Name
INFIBRA, MODEL 1200
Manufacturer
Date Cleared
2006-09-08
(80 days)
Product Code
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL DENTAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Infibra is intended for use by dentists to provide reinforcement to acrylic or composite resins used for dental restorations. It can be used for the following applications: As reinforcement in manufacturing and/or repairing full or partial dentures as well as overdentures, night-guards and orthodontic appliances. To repair and reinforce resin or composite prostheses including temporary and permanent bonded and removable bridges. To reinforce splints used to immobilize teeth.
Device Description
InFibra is a fiber reinforcement used to reinforce dental resins. It is made of ultra-high-molecularweight polyethylene (UHMW). The fibers are braided and not leno-weave treated.
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K Number
K023888Device Name
CIMOFLUOR
Manufacturer
Date Cleared
2003-03-05
(104 days)
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL DENTAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended for temporary root canal filling during endodontic therapy.
Device Description
CIMOFLUOR
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