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510(k) Data Aggregation
K Number
K181331Device Name
JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White
Manufacturer
Juvora, Ltd.
Date Cleared
2018-12-21
(214 days)
Product Code
EBI, EBF, EBG
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
Juvora, Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The JUVORA™ Oyster White Dental Disc is a thermoplastic dental disc. They are intended to be used for the manufacture of:
i) full and partial removable dentures and implant overdentures.
ii) copings, substructures (cemented or uncemented), frameworks for permanent and transitional anterior or posterior crowns and bridgework.
Device Description
The JUVORA™ Oyster White Dental Disc is a thermoplastic dental disc.
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K Number
K160918Device Name
JUVORA Dental Disc, Ceramill PEEK by JUVORA
Manufacturer
JUVORA
Date Cleared
2017-02-13
(315 days)
Product Code
EBI, EBF, EBG
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
JUVORA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The JUVORA™ Dental Disc is a thermoplastic dental disc. They are intended to be used for the manufacture of:
i) full and partial removable dentures and implant overdentures.
ii) copings, substructures (cemented), frameworks for permanent and transitional anterior or posterior crowns and bridgework.
Device Description
JUVORA™ Dental Discs are cylindrical, puck-shaped discs made from the polymer, PEEK-OPTIMA™ LT1, that are used in the CAD/CAM manufacture of removable dental prostheses. The disc is provided non-sterile, without any accessories, and are single use.
The JUVORA™ Dental Discs are provided in a variety of sizes:
Ø 95 x 16 mm Ø 95 x 20 mm Ø 98 x 16 mm Ø 98 x 18 mm Ø 98 x 20 mm Ø 98 x 22 mm Ø 98 x 25 mm Ø 98 x 30 mm Ø 101 x 13 mm
Ø 101 x 20 mm
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K Number
K132725Device Name
JUVORA DENTQAL DISC
Manufacturer
JUVORA
Date Cleared
2014-01-23
(146 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
JUVORA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Juvora Dental Disc is a thermoplastic dental disc for the manufacture of full and partial removable dentures and implant overdentures.
Device Description
JUVORA™ Dental Discs are cylindrical, puck-shaped discs made from the implantgrade polymer, PEEK-OPTIMA® LT1, that are used in the CAD/CAM manufacture of removable dental prostheses. The discs are provided either with or without a step.
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