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510(k) Data Aggregation
K Number
K223706Device Name
PMMA BLOCK
Manufacturer
Huliang(shanghai) Bio-Tech Co., Ltd.
Date Cleared
2023-05-12
(151 days)
Product Code
EBG, EBI, MQC
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
Huliang(shanghai) Bio-Tech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PMMA BLOCK is used for the fabrication removable or temporary dental structures, such as crowns and bridges using milling technology using CAD/CAM.
Indications for Use:
- Temporary anterior and posterior crowns;
- Temporary anterior and posterior bridges;
- Removable structures for dentures;
- Removable structures for therapeutic restorations (night guards, bite splints or occlusal splints).
Device Description
PMMA BLOCK is a circular solid (disc) or rectangular solid (block) of PMMA with or without post attachment for use in a CAD/CAM milling machine for production of provisional restorative prostheses such as dental crowns and bridges and removable dental structures. These blocks are available in a variety of shapes for different milling systems and are also available in variety of dental shades.
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