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Found 18 results
510(k) Data Aggregation
K Number
K231552Device Name
Dia-Cem
Manufacturer
Diadent Group International
Date Cleared
2023-07-28
(59 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
Diadent Group International
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Resin crowns, bridges, inlays and onlays
- Glass Ceramic, Porcelain crowns, inlays and onlays(includes alumina and zirconia)
- Metal crowns, bridges, inlays and onlays(includes porcelain-fused-to-metal and composite-to-metal)
- Metal(prefabricated or cast) and fiber posts
Device Description
Dia-Cem is a radiopaque resin cement that can be used in self-cure or light-cure mode. It corresponds to type 2 and 3 of ISO 4049 and contains more than 60% of inorganic filler. Dia-Cem shows high bonding strength on various materials, yet excess material can be easily removed. 3 different shades are available: TR, A2, and A3O.
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K Number
K220804Device Name
Dia-X Bond Universal
Manufacturer
Diadent Group International
Date Cleared
2022-06-15
(89 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
Diadent Group International
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- All direct restorations
- All indirect restorations
- Desensitizing/sealing of tooth
- Intra-oral repairs
Device Description
Dia-X Bond Universal is a universal adhesive capable of total, self, and selective etching as it consists of a single bottle of etching, primer, and adhesive resin. It can be used for both direct bonding of restorations.
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K Number
K213401Device Name
DIAPLUS Universal
Manufacturer
Diadent Group International
Date Cleared
2022-01-31
(105 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
Diadent Group International
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- 1. All direct restorations
- 2. All indirect restorations
- 3. Desensitizing/sealing of tooth
- 4. Intra-oral repairs
Device Description
It is a 7th generation dentin adhesive system that handles all the functions of the conditioner primer bonding resin. The polymerization method is photopolymerization type, and after being applied to the tooth surface, the solvent is volatilized and polymerized in the drying process to perform the function as a dentine adhesive.
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K Number
K210421Device Name
Diafil & Diafil Capsule
Manufacturer
Diadent Group International
Date Cleared
2021-06-28
(137 days)
Product Code
EBF, KLE
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Diadent Group International
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DiaFil & DiaFil Capsule composite material which has resin organic and inorganic fillers as ingredients, which are being used for aesthetic restoration by getting polymerized directly in the oral cavity. - Direct anterior and posterior restorations
Device Description
The product belongs to Group 1, Class 2 of Type 1 according to the standard classification of ISO 4049. It is a nano hybrid typed light-curved complex resin for aesthetic restoration for both anterior and posterior parts, which is used for restoration that requires aesthetics through decay and damage in a form of paste with unpolymerized dimethacrylate monomer, inorganic filler, and photoinitiators mixed. That is, after recovering with the unpolymerized product, to make a hard restoration by polymerizing through dental visible-ray polymerizer.
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K Number
K210333Device Name
DiaPaste
Manufacturer
Diadent Group International
Date Cleared
2021-03-25
(48 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Diadent Group International
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Aqueous ointment material that temporarily fills the root canal for the following indications: Apexification Temporary root filling Root canal filling for primary teeth Vital pulpotomy Temporary pulp capping
Device Description
Diapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal filling material.
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K Number
K200174Device Name
DIA-ROOT BIO MTA
Manufacturer
Diadent Group International
Date Cleared
2020-09-18
(239 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Diadent Group International
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DIA-ROOT BIO MTA is used for pulp capping (direct pulp capping or partial pulpotomy) and repair of root perforation. Other indications for use include: repair of root resorption, root end filling, apexification and pulpotomy.
Device Description
DIA-ROOT BIO MTA is a hydraulic product that hardens by reacting with water. It is designed for the protection of pulp such as direct pulp capping, pulpotomy, and perforation. The subject device is packaged with Cap & Body, Mixing pad, and Spatula.
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K Number
K200809Device Name
D-LUX+
Manufacturer
Diadent Group International
Date Cleared
2020-08-07
(133 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
Diadent Group International
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The D-Lux+ is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 385~515nm waveband of visible light.
Device Description
The subject device is packaged with the following: D-Lux+ Handpiece, D-Lux+ Charger, Light Probe, Light Protector, C-Battery, Adapter, Power Cord, Disposable Sheaths(200ea/Box), Instruction Manual. The D-Lux+ Handpiece turns on/off the power, sets the mode and time, and controls the operation. The handpiece includes a battery. The C-Battery is included in the handpiece and supplies power to the handpiece. The D-Lux+ Charger charges the battery when the handpiece is placed on this device. The Adapter supplies power to the charger. The Power Cord is a cord to conduct power to an adapter. Disposable sheaths protect products and patients from contamination. Disposable, so reuse is prohibited. The Light Probe is connected to the handpiece so that the light emitted from the light source (LED) reaches the restoration. The Light Protector is inserted into the handpiece and used to protect the eyes from emitted light. The Instruction Manual is a document that describes information that the user needs to know, such as precautions, operating procedures, and how to use the device.
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K Number
K200175Device Name
DIA-ROOT BIO Sealer
Manufacturer
Diadent Group International
Date Cleared
2020-06-25
(154 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Diadent Group International
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DIA-ROOT BIO Sealer is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials.
Device Description
DIA-ROOT BIO Sealer is a hydraulic material, and a premixed form that does not require mixing. It blocks the root canal by hardening by reacting with water in the oral cavity. It is contained in a waterblocked syringe and corresponds to ISO 6876:2012, Dentistry-Root canal sealing materials. DIA-ROOT BIO Sealer has two models and they are packaged with components; Disposable tip, Silicone cap.
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K Number
K192392Device Name
DiaPlus
Manufacturer
Diadent Group International
Date Cleared
2020-05-26
(266 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
Diadent Group International
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As a dentine/enamel total etching bonding system for direct adhesion, it is used in the adhesion of all direct restoration substances.
- Bonding of direct composite
- Bonding to composite and set amalgam
- Bonding of indirect restoration-Porcelain, Composite (Inlays, Onlays, Veneers, Crowns)
Device Description
DiaPlus is a photopolymerization type dentine and enamel adhesive as a 5th generation dentine adhesion system that can be applied to all types of composite resin restorations.
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K Number
K190091Device Name
Diapaste
Manufacturer
Diadent Group International
Date Cleared
2020-03-27
(434 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Diadent Group International
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Aqueous ointment material that temporarily fills the root canal for the following indications:
- Apexification
- Temporary root filling
- Root canal filling for primary teeth
- Vital pulpotomy
- Temporary pulp capping
Device Description
Diapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal filling material.
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