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510(k) Data Aggregation
K Number
K250267Device Name
Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068)
Manufacturer
Kettenbach GmbH & Co. KG
Date Cleared
2025-03-14
(43 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
**Kettenbach GmbH **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Visalys® Bulk Fill: Loss of tooth substance due to caries, dental wear or developmental disorders. Techniques: Class I and II restorations, non-tunneled class III restorations, filling in deciduous teeth, core buildups, cavity floor elevation, repair of direct restorations after appropriate pretreatment and splinting / locking of teeth.
Visalys® Bulk Flow: Loss of tooth substance due to caries, fractures, dental wear or developmental disorders. Techniques: Class I and II restorations, non-tunneled class III restorations, filling in decidious teeth, core build-ups, cavity lining, cavity floor elevation, blocking out undercuts, repair of direct restorations after appropriate pretreatment, extended fissure sealing and splinting / locking of teeth.
Device Description
Visalys® Bulk Fill is a light-cured, nano-hybrid filling composite that can be modeled and is available in a universal shade. For adhesive cementation, a dentin-enamel bond is used. The material is available in screw syringes and can be applied in layers up to 4 mm thick. The filling material contains approx. 82% inorganic fillers by weight. The radiopacity is 2.5 mm aluminium*. The color stability meets the requirements of DIN EN ISO 4049. Visalys® Bulk Fill is thus suitable for both posterior teeth and also for fillings without tunnel preparation in the anterior tooth area, particularly class III and V.
Visalys® Bulk Flow is a light-cured, flowable nano-hybrid filling composite and is available in a universal shade. For adhesive cementation, a dentin-enamel bond is used. The material is available in syringes and can be applied in layers up to 4 mm thick. The filling material contains approx. 72% inorganic fillers by weight. The radiopacity is 2.0 mm aluminium*. The color stability meets the requirements of DIN EN ISO 4049. Visalys® Bulk Flow is thus suitable for both posterior teeth and also for fillings without tunnel preparation in the anterior tooth area, particularly class III and V. Capping is not necessary.
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K Number
K230333Device Name
Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)
Manufacturer
Kettenbach GmbH & Co. KG
Date Cleared
2023-07-24
(167 days)
Product Code
LBH, PRO
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
**Kettenbach GmbH **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Profisil® Fluoride Varnish is a 5 % sodium fluoride varnish which produces mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.
Device Description
Profisil® Fluoride Varnish is designed to securely adhere to the tooth surface for several hours while releasing fluoride ions. The varnish contains 5 % sodium fluoride suspended in a mucosa-friendly, pleasantly flavored dimethicone gel. The varnish is available in following versions: mint, berry and unflavored.
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K Number
K191527Device Name
Visalys CemCore, Visalys Cem Core Try In Paste
Manufacturer
Kettenbach GmbH & Co. KG
Date Cleared
2019-11-08
(151 days)
Product Code
EMA, EBF
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
**Kettenbach GmbH **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Visalys® CemCore is a dual-curing, adhesive cementation and core build-up composite, which is intended to be used for: a) Permanent cementation of · crowns, bridges, inlays, veneers and adhesive bridges made of metal, ceramic, composite, hybrid and oxide ceramics • root posts and indirect core build-ups b) Composite for · adhesive core build-ups Visalys® CemCore Try In Paste is a water-soluble polyethylene glycol paste for shade matching: · To check the shade selected prior to permanent cementation with Visalys® CemCore. · For covering the cement joint to reduce a layer of inhibition.
Device Description
Visalys® CemCore is a dual-curing composite containing fluoride for adhesive cementation of indirect restorations and root posts and can be used to fabricate radiopaque core build-ups and abutment fillings. Due to the Active-Connect-Technology (ACT) Visalys® CemCore includes an additional initiator system for the optimization of the adhesive bond. BPA or BPA precursors are not used in the manufacturing process of this device. Visalys® CemCore shall only be used in combination with self-etching Visalys® Tooth Primer. Visalys® Restorative Primer is recommended as the primer for the restoration surfaces. Visalys® CemCore is easy to use and has high adhesive strength and good flowability with stable consistency. Visalys® CemCore is offered in the shades Universal (A2/A3), Dark (A4), Opaque, Bleach and Translucent. The paste should be mixed and dispensed directly from a double syringe with the corresponding mixing tips blue (MLø 3.2 mm). Visalys® CemCore Try in Paste serves to simulate the shade effect of the selected Visalys® CemCore shade on ceramic restorations and for covering the cement joint to reduce a layer of inhibition. The water-soluble paste corresponds in shade and translucence with the completely cured Visalys® CemCore. Visalys® CemCore Try In Paste is offered in the shades Universal (A2/A3), Dark (A4), Opaque, Bleach and Translucent. The paste is dispensed from a syringe and syringe tip.
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K Number
K191523Device Name
Visalys Restorative Primer
Manufacturer
Kettenbach GmbH & Co. KG
Date Cleared
2019-10-09
(121 days)
Product Code
KLE, DEV
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
**Kettenbach GmbH **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Restoration primer for treatment of:
metal/silicate ceramics, oxide ceramic and composite surfaces
- · to cement prosthetic restorations
- · to repair fractured restorations with composite materials
Device Description
Visalys® Restorative Primer with adhesive monomers (10-MDP, silane methacrylate) is for building up adhesive surfaces on restoration materials (metal, composite, as well as silicate and oxide ceramics). Visalys® Restorative Primer is a single component primer. Do not light cure Visalys® Restorative Primer. BPA or BPA precursors are not used in the manufacturing process of this device.
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K Number
K191524Device Name
Visalys Tooth Primer
Manufacturer
Kettenbach GmbH & Co. KG
Date Cleared
2019-09-29
(111 days)
Product Code
KLE, DEV
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
**Kettenbach GmbH **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For permanent cementation of tooth structure to: · crowns, bridges, inlays, veneers and adhesive bridges in combination with Visalys® CemCore · root posts in combination with Visalys® CemCore and Visalys® Core · indirect core build-ups in combination with Visalys® CemCore For build-up adhesive bond to structure with Visalys® CemCore and Visalys® Core to fabricate: · adhesive core build-ups
Device Description
Visalys® Tooth Primer is a self-etching single-component primer with acidic polymers (10-MDP) for adhesive bonding of Visalys® CemCore and Visalys® Core to the dental hard substance. The primer can be applied without additional etching or after selective etching the enamel. Do not light cure Visalys® Tooth Primer. BPA or BPA precursors are not used in the manufacturing process of this device.
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K Number
K143104Device Name
Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X
Manufacturer
KETTENBACH GMBH & CO KG
Date Cleared
2015-03-25
(147 days)
Product Code
EBF, DEV
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
**KETTENBACH GMBH **& CO KG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Visalys® Core, PL-Core, PL-Core-C, PL-Core-X are dual-curing core build-up materials which are intended to be used for different types of core build-ups and luting of root posts
Device Description
The Visalvs® Core / PL-Variants are all available in two delivery systems: 1:1 25ml automix catridge, 1:1 5ml double syringe. The pastes should be mixed and dispensed directly from the 5-ml-double syringe with the corresponding mixing tips (MLT Ø 3.2 mm) or using an dispensing gun DS-24 2:1/1:1 for the 25-ml-cartridge with the corresponding mixing tips (MBT Ø 4.2 mm). The Visalys® Core / PL-Core-Variants are available in four different variations: Visalys® Core, PL-Core, PL-Core-C, and PL-Core-X. The Visalys® Core / PL-Core-Variants are available in the following shades: White, Dentin, and Blue. Visalys® Core, developed by Kettenbach, is a dual-curing, fluoride-containing composite used for the fabrication of radiopaque core build-ups and core fillings. The automixing, two-component system is based on a multifunctional acryl composite. BPA or BPA precursors are not used in the manufacturing process of this device. Visalys® Core has a firm consistency with good flow behavior. It is compatible with common light and dual-curing adhesives available on the market (Active Connect Technology) and already achieves strength values as specified with self-curing. Curing can be controlled as required at any time using optional light-curing. PL-Core-C, developed by Kettenbach, is a dual-curing, fluoride-containing composite used for the fabrication of radiopaque core build-ups and core fillings. The automixing, two-component system is based on a multifunctional acryl composite. BPA or BPA precursors are not used in the manufacturing process of this device. PL-Core-C has a firm consistency with good flow behavior. It is compatible with common light and dual-curing adhesives available on the market (Active Connect Technology) and already achieves strength values as specified with self-curing. Curing can be controlled as required at any time using optional light-curing. PL-Core-X, developed by Kettenbach, is a dual-curing, fluoride-containing composite used for the fabrication of radiopaque core build-ups and core fillings. The automixing, two-component system is based on a multifunctional acryl composite. BPA or BPA precursors are not used in the manufacturing process of this device. PL-Core-X has a firm consistency with good flow behavior. It already achieves strength values as specified with self-curing, however curing can be controlled as required at any time using optional light-curing. PL-Core, developed by Kettenbach, is a dual-curing, fluoride-containing composite used for the fabrication of radiopaque core build-ups and core fillings. The automixing, twocomponent system is based on a multifunctional acryl composite. BPA or BPA precursors are not used in the manufacturing process of this device. PL-Core has a firm consistency with good flow behavior. It already achieves strength values as specified with self-curing, however curing can be controlled as required at any time using optional light-curing. Differences between the variants: 1. Visalys® Core and PL-Core C are compatible with all common light and dualcuring adhesives available on the market. 2. PL-Core and PL-Core X can be applied with bondings for which the use with dualcuring composites is recommended. 3. Radiopacity is available in 2.5mm Al (Visalys® Core and PL-Core-X) or 2.0mm Al (PL-Core-C and PL-Core).
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K Number
K122039Device Name
KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B
Manufacturer
KETTENBACH GMBH & CO KG
Date Cleared
2012-12-27
(169 days)
Product Code
EBG, DEV
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
**KETTENBACH GMBH **& CO KG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Kingscross temporary crown and bridge material is intended to be used for fabrication of temporary prostheses, such as crowns, partial crowns, bridges, inlays, onlays and veneers, and for customization of prefabricated acrylic and metal crowns and for fabrication of long-term temporary restorations until a permanent restoration is fabricated.
Device Description
Kingscross, which was developed by Kettenbach, is a highly esthetic composite of fabricating temporary restorations. The two-component system based on a multifunctional acryl composite is produced using no Bisphenol-A or Bisphenol-A precursors in the manufacturing process It has similar properties to a filling material and is available in the following shades: A1. A2, A3, A3.5, B1, B3, Bleach white. Kingscross temporary restorations can also be adjusted and customized using lightcuring composites. The two components (base and catalyst paste) are mixed by using a 50 ml cartridge at the ratio of 10:1 with a dispensing gun. By varying the percentages of two chemical components in the base paste with different percentages of organic peroxide in the catalyst paste four different product variations with different mechanical properties are realized.
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K Number
K113279Device Name
IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT
Manufacturer
KETTENBACH GMBH & CO KG
Date Cleared
2011-11-14
(7 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
**KETTENBACH GMBH **& CO KG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Identium® Impression Materials are intended to:
- be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums;
- provide models for study and for production of restorative prosthetic devices.
Identium® Heavy (regular 1:1, fast 1:1) is to be used as a heavy-bodied impression material in one-step technique (double mix) for:
- Impressions for crowns/bridges, inlays/onlays and veneer preparations
- Functional impressions
- Impressions for full or partial dentures
- Implant impressions
Identium® Medium (regular 1:1, fast 1:1) is to be used as a medium-bodied tray or syringeable impression material in one-step technique (monophase or double mix) for:
- Impressions for crowns/bridges, inlays/onlays and veneer preparations
- Functional impressions
- Fixation impressions
- Implant impressions
Identium® Scan Heavy (regular 1:5) is to be used as a heavy-bodied impression material in one-step technique (double mix) for:
- Impressions for crowns/bridges, inlays/onlays and veneer preparations
- Functional impressions
- Impressions for full or partial dentures
- Implant impressions
Identium® Scan Medium (regular 1:5) is to be used as a medium-bodied tray or syringeable impression material in one-step technique (monophase or double mix) for:
- Impressions for crowns/bridges, inlays/onlays and veneer preparations
- Functional impressions
- Fixation impressions
- Implant impressions
Identium® Scan Light (regular 1:1) is to be used as a syringeable light-bodied impression material in one-step technique (double mix) for:
- Impressions for crowns/bridges, inlays/onlays and veneer preparations
- Reline impressions
- Impressions for full or partial dentures
Device Description
Identium® Impression Materials are addition-curing, elastomeric materials. Identium® Impression Materials have excellent flow and hydrophilic properties, high shear strength, dimensional accuracy and resistance to permanent deformation. The Identium® Impression Materials include three different viscosities (heavy-bodied, medium-bodied, light-bodied), available in an assortment of delivery systems: Traditional 1:1 50 ml automix cartridge version and 5:1 362 ml foil bags for use in most automatic dispensing and mixing systems (heavy-bodied and medium-bodied versions only). Most of the Identium® Impression Materials are available in a regular-set and a fast-set version.
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K Number
K092867Device Name
IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT
Manufacturer
KETTENBACH GMBH & CO KG
Date Cleared
2009-10-01
(13 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
**KETTENBACH GMBH **& CO KG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Identium® Impression Materials are intended to: be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums; provide models for study and for production of restorative prosthetic devices.
Identium Heavy is to be used as a heavy-bodied impression material in one-step technique (double mix) for: Impressions for crowns/bridges, inlays/onlays and veneer preparations. Functional impressions. Impressions for full or partial dentures. Implant impressions.
Identium Medium is to be used as a medium-bodied tray or syringeable impression material in one-step technique (monophase or double mix) for: Impressions for crowns/bridges, inlays/onlays and veneer preparations. Implant impressions. Fixation impressions. Functional impressions.
Identium Medium soft is to be used as a medium-bodied tray or syringeable impression material in one-step technique (monophase or double mix) for: Impressions for crowns/bridges, inlays/onlays and veneer preparations Functional impressions Reline impressions
Identium Light is to be used as a light-bodied, syringeable impression material in one-step technique (double mix) for: Impressions for crowns/ bridges, inlays/ onlays and veneer preparations. Reline impressions. Impressions for full or partial dentures.
Device Description
Identium® Impression Materials are addition-curing, elastomeric materials. Identium® Impression Materials have excellent flow and hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The Identium® Impression Materials family consists of three different viscosities (heavy-bodied, medium-bodied, light-bodied). They are available in two delivery systems, for use in most automatic dispensing and mixing systems: standard 1:1 (50 ml automix cartridges) and 5:1 (362 ml foil bags). The Identium® Impression Materials are available in regular-set and fastset versions.
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K Number
K083701Device Name
PANASIL INITIAL CONTACT AND PANASIL TRAY
Manufacturer
KETTENBACH GMBH & CO KG
Date Cleared
2009-01-09
(25 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
**KETTENBACH GMBH **& CO KG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Panasil® Impression Materials are intended to: be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums; provide models for study and for production of restorative prosthetic devices.
Panasil® initial contact (regular, regular fast, light fast, x-light, x-light fast) is to be used as a syringeable impression material for: Two-step putty-wash impression technique. One-step putty-wash impression technique. One-step impression technique using a foil (plastic putty spacer). One-step impression technique (simultaneous technique) using dual viscosities. Reline impressions. Fabricating full or partial dentures.
Panasil® tray (fast 1:1, soft fast 5:1, soft fast 1:1) is to be used as a heavy-bodied material for: One-step impression technique (simultaneous technique) using single or dual viscosities. Two-step impression technique using dual viscosities. Functional impressions.
Device Description
Panasil® Impression Materials are addition-curing, elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The Panasil Impression Materials include four different viscosities (heavy-bodied, medium-bodied, light-bodied, x-light-bodied), available in an assortment of delivery systems: traditional 1:1 50 ml automix cartridge and 5:1 362 ml foil bags for use in most automatic dispensing and mixing systems.
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