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510(k) Data Aggregation
K Number
K122348Device Name
QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW
Manufacturer
Date Cleared
2012-10-15
(73 days)
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
RECHERCHES TECHNIQUES DENTAIRES (R.T.D.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The splinting system is designed for use in oral splintings or to support laboratory-processes composite bridge/denture work
- QUARTZ SPLINT™ UD (Unidirectional): Composite laboratory bridge strengthening/ reinforcement
- QUARTZ SPLINT™ WOVEN: Direct Splinting/Bridge and Implant positioning reinforcement. Splinting of mobile teeth/temporary stabilization in Clinical use. Retention of teeth subsequent to orthodontic therapy.
- OUARTZ SPLINT™ ROPE: Laboratory splint fabrication for bridge reinforcement or denture repair .- Periodontal splinting of mobile teeth in Clinical use.
- QUARTZ SPLINT™ MESH: Denture reinforcement and denture repair.
- QUARTZ SPLINT™ RESIN: for additional wetting during the application of the finished splints
- QS FLOWTM: a nano filled, light cured flowable composite designed to be used with the QUARTZ SPLINT system for reinforcement and stabilizing of mobile teeth.
Device Description
Quartz Splint is made of quartz fibers impregnated a light-cured resin matrix. Quartz Splint is a complete system that contains different structures and it is available in different structures and sizes:
Quartz Splint UD
Quartz Splint WOVEN
Ouartz Splint ROPE
Quartz Splint MESH
Ouartz Splint Resin/Flow
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