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510(k) Data Aggregation
K Number
K122955Device Name
DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM
Manufacturer
WRIGHT HEALTH GROUP LTD.
Date Cleared
2013-03-01
(157 days)
Product Code
ELM
Regulation Number
872.3590Why did this record match?
Applicant Name (Manufacturer) :
WRIGHT HEALTH GROUP LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These dental plastic teeth are parts used for denture fabrication. PMMA is mixed with monomer in a polymenzation process. The plastic teeth are part of dentures made to fit a patient's mouth which are removable or may be attached to dental implant devices.
Device Description
The synthetic plastic teeth are used in the production of dentures. They are produced from a I he synuletic process. Polymethylmethacrylate or PMMA is mixed with methylmethacrylate monomer, a cross linking agent and non-toxic pigments under heat and pressure. Once the monomer, a cross iniking agoit and non teen are checked for flash and polished according to the relevant model characteristics.
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