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510(k) Data Aggregation
K Number
K243720Device Name
3Delta UNlimited
Manufacturer
DeltaMed GmbH
Date Cleared
2024-12-18
(15 days)
Product Code
EBF, EBG, EBI, PZY
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
DeltaMed GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
3Delta UNlimited is a light-curing dental resin for restoring or improving chewing function by prosthetically
- reconstructing damaged or missing teeth using additively fabricated
- permanent full crowns, veneers, inlays, onlays
- temporary crowns & bridges (max. two consecutive pontics)
- monolithic full and partial dentures
- artificial denture teeth
Device Description
3Delta UNlimited is a light-curing dental resin.
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K Number
K230341Device Name
ACRIFIX
Manufacturer
DeltaMed GmbH
Date Cleared
2023-04-06
(57 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
DeltaMed GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Repair of removable partial and full dentures
Device Description
Not Found
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K Number
K212541Device Name
3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix
Manufacturer
DeltaMed GmbH
Date Cleared
2022-01-10
(151 days)
Product Code
EBI, KLE
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
DeltaMed GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Production of dentures.
- 3Delta Denture Base: Light curing resin for additive manufacturing of denture bases
- 3Delta Denture Bond: Light curing bonding agent for denture teeth and denture bases
- 3Delta Denture Fix: Dual curing cementation composite for denture teeth and denture bases
Device Description
Not Found
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K Number
K211804Device Name
3Delta Crown
Manufacturer
DeltaMed GmbH
Date Cleared
2021-12-06
(178 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
DeltaMed GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Additive production of permanent anterior and posterior restorations, e.g.
- Single-tooth crowns
- Veneers, inlays, onlays
Device Description
Not Found
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K Number
K200039Device Name
P pro Crown & Bridge
Manufacturer
DeltaMed GmbH
Date Cleared
2020-07-31
(205 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
DeltaMed GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Additive production of temporary anterior and posterior restorations, e.g.
- Single tooth crowns.
- Bridges (max. six units, max. two consecutive pontics).
- Veneers, Inlays, Onlays.
Device Description
P pro Crown & Bridge is a flowable, light-curing, acrylate-based composite material for the additive production of temporary anterior and posterior restorations.
It consists of multifunctional acrylic resins and fillers made of inorganic fillers ranging in size from 0.04 - 0.2 um. The raw materials used in the preparation have been used for many years in dental products.
Exposition: The temporary crown and bridge resin has an intended gingival, enamel/dentine contact for more than 30 days.
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K Number
K102776Device Name
EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM
Manufacturer
DELTAMED GMBH
Date Cleared
2011-02-18
(147 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
DELTAMED GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
e-DENT TEMPORARY resin is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral curing light equipment.
Device Description
e-DENT TEMPORARY RESIN is a radiopaque, filled, resin-based temporary dental restorative composite. In general terms, the device is a typical, high quality, esthetic dental composite, composed of difunctional acrylic monomers and silaceous fillers. The product will polymerize on exposure to high-intensity incandescent illumination, yielding a hard, esthetic, temporary restoration that mimics natural tooth structure.
e-DENT TEMPORARY RESIN is intended to be fabricated in a laboratory-based, additive, Computer-Aided Manufacturing (CAM) and curing system, such as the EXTRA-ORAL CURING SYSTEM disclosed in this submission. The curing system consists of two pieces of equipment used to manufacture photocurable dental resin devices in a dental laboratory, using accompanying software to form and cure the devices.
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