Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X
Device Facts
| Record ID | K143104 |
|---|---|
| Device Name | Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X |
| Applicant | Kettenbach GmbH & Co. KG |
| Product Code | EBF · Dental |
| Decision Date | Mar 25, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3690 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for 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 Story
Visalys Core/PL-Core variants are dual-curing, fluoride-containing, radiopaque composite materials used for core build-ups and luting of root posts. The device is a two-component system based on multifunctional acryl composite, free of BPA or BPA precursors. It is supplied in 25ml automix cartridges or 5ml double syringes for manual dispensing. Used in dental clinics by dentists; the material is applied to the tooth structure, where it cures via self-curing or optional light-curing. The material provides a firm consistency with flow behavior, allowing for structural support of dental restorations. Benefits include radiopacity for clinical visibility and compatibility with various light/dual-curing adhesives to facilitate restorative procedures.
Clinical Evidence
Bench testing only. No clinical data. Biocompatibility testing performed per ISO 10993 (cytotoxicity, mutagenicity, sensitization). Mechanical property testing performed per ISO 4049, ISO 9917-1, ASTM D 4473, and ADA specifications, confirming equivalence to predicate devices.
Technological Characteristics
Dual-curing, fluoride-containing, radiopaque multifunctional acryl composite. Delivery via 1:1 automix cartridge or double syringe. Radiopacity: 2.0mm-2.5mm Al. Standards: ISO 4049 (depth of cure, film thickness, water sorption, solubility, radio-opacity, E-Modulus, flexural strength, color stability), ISO 9917-1 (compressive strength), ASTM D 4473 (working time, cure point), ADA Spec 27 (diametral tensile strength), ANSI ADA Spec 80 (shade consistency, color stability).
Indications for Use
Indicated for core build-ups and luting of root posts in vital and non-vital teeth.
Regulatory Classification
Identification
Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.
Predicate Devices
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2015
Kettenbach GmbH & Co KG Ms. Katja Simon Regulatory Affairs Manager Im Heerfeld 7 35713 Eschenburg Hessen GERMANY
Re: K143104 Trade/Device Name: Visalys® Core, PL-Core, PL-Core-C, PL-Core-X Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: II Product Code: EBF Dated: February 10, 2015 Received: February 13, 2015
Dear Ms. Simon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for use
510(k) number (if known):_ K143104
Device Name: Visalys® Core, PL-Core, PL-Core-C, PL-Core-X
Indication for 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
Prescription Use______________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________
(21 CFR 801 Subpart C)
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
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# 510(k) Summary
In accordance with the requirements of the Safe Medical Device Act, Kettenbach GmbH & Co KG herewith submits a Summary.
#### A. Name and address of manufacturer:
Kettenbach GmbH & Co KG Im Heerfeld 7 35713 Eschenburg Germany Establishment Registration No.: 9681356 Owner/Operator Number: 9022134
#### Name, title and phone number of official correspondent:
Simon, Katja Regulatory Affairs Manager Im Heerfeld 7 35713 Eschenburg Germany Phone: + 49 277 4705 0 E-mail: katja.simon@kettenbach.de
#### Name, title and phone number of U.S. Agent (Contact):
Roggenbau, Wilfried InterGest North America LLC. 400 Oser Ave., Suite 1650 Hauppauge, NY 11788 Phone: 631 5010500 ext Fax: 631 5011060 Email: roggenbauw@intergestna.com
March 24th, 2015 Date of preparation:
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# B. Device Identification:
# Visalys® Core
Device Trade Name: Versions: Common Name:
Visalys® Core, PL-Core, PL-Core-C, PL-Core-X white, dentin, blue Dual-curing core build-up material
#### Classification of the device:
Device Classification Name: Product Code: Device Classification No.: Panel: Regulatory Status:
Material, Tooth Shade, Resin EBF Part 872.3690 Dental Class II
# C. Predicate devices:
| Device Trade Name: | LuxaCore Dual |
|--------------------|------------------------|
| Applicant: | DMG USA, Inc. |
| 510(k) No.: | K012307 |
| Device Trade Name: | MULTICORE FLOW |
| Applicant: | Ivoclar Vivadent, Inc. |
| 510(k) No.: | K040795 |
| Device Trade Name: | Rebilda DC |
| Applicant: | Voco, GmbH |
| 510(k) No.: | K040795 |
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# D. 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.
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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)
#### E. Indications for 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
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| Product | Visalys® Core | Luxacore<br>Dual | Multicore<br>Flow | Rebilda DC | Product | Visalys® Core | Luxacore<br>Dual | Multicore<br>Flow | Rebilda DC |
|------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|
| Manufacturer | Kettenbach<br>GmbH | DMG GmbH | Ivoclar<br>Vivadent AG | Voco GmbH | Manufacturer | Kettenbach<br>GmbH | DMG GmbH | lvoclar<br>Vivadent AG | Voco GmbH |
| Product<br>description | Visalys® Core,<br>developed by<br>Kettenbach, is a dual-<br>curing, fluoride-<br> | Luxacore-Dual is an<br>automatic mixing,<br>dual cure composite<br>that has been<br>specially developed<br>for all types of core<br>build-ups and build-<br>up fillings.<br>Radiopaque<br>Luxacore-Dual<br>stands out due to its<br>high compressive<br>strength, and it cuts<br>like dentin. The<br>curing time can be<br>self-determined due<br>to additional light<br>curing. It is possible<br>to apply Luxacore-<br>Dual directly using<br>the Intra-oral-Tip and<br>Endo-Tip. | MultiCore Flow is a<br>dual-curing,<br>radiopaque<br>composite containing<br>fluoride fillers that<br>demonstrates<br>excellent mechanical<br>properties for core<br>build-ups. It cures<br>chemically without<br>the use of light. Light-<br>curing is optional.<br>MultiCore Flow is<br>available in a double-<br>barrel cartridge or a<br>double-push syringe<br>with automixing tips<br>for fabricating core<br>build-ups using<br>matrices. | Rebilda DC is a dual-<br>curing, highly<br>radiopaque flowable<br>composite with<br>excellent mechanical<br>properties for core<br>build-up. Rebilda DC<br>is available in three<br>different shades to<br>cover a large range<br>of indications: Blue to<br>visualize the<br>transition between<br>material and tooth<br>substance, especially<br>in molar and pre-<br>molar areas; dentin<br>shade for high<br>aesthetic de-mands,<br>e.g. under full<br>ceramic restorations<br>or composite resto-<br>rations with high<br>translucency; white<br>as a possibility to<br>visualize preparation<br>margins an simulta-<br>neously meet<br>aesthetic demands. | Available<br>Shades | Dentin, White, Blue | A3. White, Blue | Medium, Light,<br>White, Blue | Dentin, White, Blue |
| Indication | Different Types of<br>core build-ups; Luting<br>of root posts | All types of core<br>build-up;<br>Cementation of root-<br>posts | Core build-up of vital<br>and non-vital teeth;<br>Adhesive<br>cementation of glass<br>fibre-reinforced<br>endodontic posts | Adhesive Core build-<br>up of vital and non-<br>vital teeth; Luting of<br>fibre-reinforced resin-<br>posts | Application<br>system | 25 ml Sulzer 2K<br>cartridge<br>5 ml Sulzer 2K<br>syringe | 25 ml Sulzer 2K<br>cartridge<br>5 ml Sulzer 2K<br>syringe | 25 ml Sulzer 2K<br>cartridge<br>5 ml Sulzer 2K<br>syringe | 25 ml Sulzer 2K<br>cartridge<br>5 ml Sulzer 2K<br>syringe |
| Storage<br>temperature | 4-24°C / 40-75°F | 2-25°C / 36-77°F | 2-8°C / 36-46°F | 4-23°C | | | | | |
# F. Comparison of technological characteristic with the predicate devices
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A comparison of parameters in respect to processing time/mechanical properties was performed. The results demonstrated the substantial equivalence to the predicate devices.
Table 1: Visalys® Core product description and characteristics in comparison to common competitor products
The Visalys® Core / PL-Core-Variants dual-curing core built-up materials are considered substantially equivalent to LuxaCore Dual (K012307), MULTICORE FLOW (K040795), Rebilda DC (K060893). There is no significant difference in intended use or technology. Each version of the Visalys Core material is substantially equivalent to the above listed predicate devices.
#### Technological Characteristics Summary:
The technological characteristics of Visalys® Core / PL-Core-Variants dual-curing core built-up materials are substantially equivalent to the above listed predicate devices technological characteristics.
Visalys® Core / PL-Core-Variants and the predicate devices are dual-curing build-up materials.
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# G. Summary of Non-Clinical Performance Testing:
Analysis of mechanical properties have showed equivalence to listed predicate devices. Analysis of compatibility with other devices used for dental restorations have shown comparable results compared to other materials on the market. Biocompatibility tests have been performed to assure biological safety in accordance with the ISO 10993 family. Tests in respect to cytotoxicity (ISO 10993-5), mutagenicity (OECD 487), sensitization (ISO 10993-10) and a chemical analysis showed, that Visalys® Core/PL-Core-Variants dual curing core build-up material biocompatibility data is comparable to other materials on the market. Therefore no toxicological risks and resulting hazards for patients, users and third parties can be concluded.
Additionally bench testing was performed to allow an evaluation of the mechanical properties of Visalys® Core in comparison to already products. The evaluation covers:
- Working time (ASTM D 4473, section 4) .
- Cure point (ASTM D 4473, section 4) .
- Depth of cure (ISO 4049 section 7.10) ●
- Film thickness (ISO 4049 section 7.5)
- . Volume shrinkage (ISO 17304)
- Water sorption (ISO 4049 section 7.12) ●
- Solubility (ISO 4049 section 7.12)
- Radio-opacity (ISO 4049 section 7.14) ●
- E-Modulus (ISO 4049 section 7.11) ●
- Flexural strength (ISO 4049 section 7.11)
- Compressive strength (ISO 9917-1, AnnexD)
- Diametral tensile strength (ADA Spec. 27 section 4.3.7) ●
- Shade consistency (ANSI ADA Spec. 80)
- Color stability (ISO 4049 and ANSI ADA Spec. 80) ●
#### Conclusion:
Kettenbach GmbH & Co KG believes that the Visalys Core / PL-Core-Variants dual curing core build-up materials are substantially equivalent to the currently legally marketed products. It does not introduce new indications for use, has similar technological characteristics and does not introduce new potential hazards or safety risks.
