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Found 4 results
510(k) Data Aggregation
K Number
K192153Device Name
Portux CAD/CAM Disc
Manufacturer
New Stetic S.A.
Date Cleared
2019-11-07
(90 days)
Product Code
EBG, EBI, MQC
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
New Stetic S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the fabrication of crowns, bridges and structures for implant supported provisional removable denture and appliance prosthetics.
- Provisional anterior and posterior crowns & bridges
- Implant and abutment supported prosthetics.
- Partial, complete and hybrid denture prosthetics (base and teeth) Removable appliances (splint)
Device Description
The Subject device are discs made of poly methyl methacrylate (PMMA), a known material used in the dental field due their physical-chemical and biocompatibility properties. These discs are intended use with dental CAD/CAM equipment to produce a variety of provisional prosthetic restorations or devices. The discs are available in a variety of disc configurations to accommodate different commercial dental CAD/CAM machines fixture requirements. In addition, the CAD/CAM discs are available in a wide variety of heights and colors to facilitate matching of patient tooth or tissue shades.
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K Number
K140125Device Name
NEW STETIC DENTAL AMALGAM ALLOY
Manufacturer
NEW STETIC
Date Cleared
2014-04-29
(103 days)
Product Code
OIV, EJJ, ELY
Regulation Number
872.3070Why did this record match?
Applicant Name (Manufacturer) :
NEW STETIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
New Stetic NU Alloy DP 40, NU Alloy DP, NU Alloy DP Active and Micronic Dental Amalgam Alloys are commonly used as a filling material for restoring the morphology and function of posterior teeth (cavities class I and II in molars and premolars), when these have lost their structure due to injuries such as cavities or fractures.
Device Description
New Stetic Dental Amalgam Alloys for dental amalgam used as a filling material for oral cavities. They are made of silver, tin and copper and free of zinc. The products are packaged in different forms: pre-dosed capsules, tablets and powder.
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K Number
K122925Device Name
NEW STETIC ARTIFICIAL TEETH
Manufacturer
NEW STETIC
Date Cleared
2013-02-12
(141 days)
Product Code
ELM, INT
Regulation Number
872.3590Why did this record match?
Applicant Name (Manufacturer) :
NEW STETIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.
Device Description
The New Stetic Acrylic Teeth are made of acrylic resin; the teeth come in various shades and sizes to fit the requirements of the specific patient.
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K Number
K102874Device Name
NEW STETIC ACRYLICS
Manufacturer
NEW STETIC
Date Cleared
2011-03-28
(179 days)
Product Code
EBI, EBG
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
NEW STETIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indication for use of the New Stetic® Acrtylics is for the repair or fabrication of the denture base.
Device Description
The product is a denture system consisting of monomer and polymer powder and liquid components.
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