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510(k) Data Aggregation
K Number
K200461Device Name
Freeprint denture
Manufacturer
Detax GmbH & Co. KG
Date Cleared
2020-11-16
(265 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
**Detax GmbH **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FREEPRINT denture is a light-cured resin indicated for the fabrication of all types of denture bases, for instance full and partial removable dentures. FREEPRINT denture is intended for continuous use in the oral environment, exclusively for professional dental work. FREEPRINT denture can be used in combination with a stereolithographic 3D printer using a 3D-printer is not part of the device.
Device Description
FREEPRINT denture is a light-cured one-component materials for the Digital Light Processing (DLP)-printing of denture base products. It is stored in 500 and 1000ml HDPE bottles. This Product is a liquid photo-curable material that is polymerized, by the photo-initiator contained in the resin. This device can be manufactured with 3D stereolithographic printer with 385nm wavelength light source. Curing in a 3D printer is related to the conditions of the printer equipment and is typically 100µm in thickness. FREEPRINT denture products are post cured with a xenon flashlight, in a nitrogen atmosphere.
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K Number
K200273Device Name
FREEPRINT temp
Manufacturer
DETAX GmbH & Co.KG
Date Cleared
2020-10-27
(266 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
**DETAX GmbH **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FREEPRINT temp is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral curing light equipment. Duration is less than 30 days in oral environment.
Device Description
FREEPRINT temp is a family of light-cured-component materials for the Digital Light Processing (DLP)-printing of temporary Crowns & Bridges (C&B) material. It is stored in 500 and 1000ml HDPE bottles. It contains materials with colours of A1, A2, and A3 based on the shade guide. This Product is a liquid photo-curable material that is polymerized by UV laser at 385nm. It can be used to make a tooth model with a photo-curable polymer that is cured by ultraviolet light. The liquid UV curing resin is cured at a specific wavelength (385nm) by the photo-initiator contained in the resin. This device can be manufactured with 3D stereolithographic printer with 385nm wavelength lightsource. Curing in a 3D printer is related to the conditions of the printer equipment and is typically 50µm in thickness. Output resolution ranges from 34µm to 75µm on the x, y axis.
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K Number
K162654Device Name
mollosil plus
Manufacturer
DETAX GmbH & Co.KG
Date Cleared
2017-03-13
(171 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
**DETAX GmbH **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used for fabricating long-term soft denture relinings by direct or indirect application.
Device Description
Not Found
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K Number
K100247Device Name
DETAX IMPLANTLINK SEMI
Manufacturer
DETAX GMBH & CO. KG
Date Cleared
2010-07-23
(177 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
**DETAX GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DETAX implantlink® semi is designed for the temporary luting of implant-retained restorations. Requires no separating agents. Luted restorations can be removed. with standard devices (i.e. Crown Butler, Corona Fix).
Device Description
Not Found
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K Number
K994012Device Name
TEMPOFIT, MODEL 02693
Manufacturer
DETAX GMBH & CO. KG
Date Cleared
2000-02-16
(82 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
**DETAX GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Material for making temporary crowns and bridges, self curing, fast setting, bis-acrylic-composite 2:1
Device Description
Not Found
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