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).

AI/ML Overview

The provided document is a 510(k) summary for the dental device Visalys® Core, PL-Core, PL-Core-C, PL-Core-X. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The document does not describe a clinical study in the typical sense (e.g., involving human participants, expert readers, or a specific test set with ground truth established by experts/pathology) to prove performance against acceptance criteria in the way envisioned by your request. Instead, it relies on non-clinical performance testing (bench testing) to demonstrate technical equivalence to existing predicate devices.

Therefore, many of the requested fields related to clinical study design, expert involvement, and reader performance cannot be filled from this document.

Here's the information that can be extracted, adapting to the nature of the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document defines acceptance criteria by comparing the device's technological characteristics and mechanical properties to those of predicate devices (LuxaCore Dual, MULTICORE FLOW, Rebilda DC). The "reported device performance" indicates that the new device meets these criteria by demonstrating equivalence.

Acceptance Criteria (Demonstrate Equivalence to Predicates based on):	Reported Device Performance (Conclusion from Non-Clinical Testing)
Working time (ASTM D 4473, section 4)	Demonstrated equivalence to predicate devices
Cure point (ASTM D 4473, section 4)	Demonstrated equivalence to predicate devices
Depth of cure (ISO 4049 section 7.10)	Demonstrated equivalence to predicate devices
Film thickness (ISO 4049 section 7.5)	Demonstrated equivalence to predicate devices
Volume shrinkage (ISO 17304)	Demonstrated equivalence to predicate devices
Water sorption (ISO 4049 section 7.12)	Demonstrated equivalence to predicate devices
Solubility (ISO 4049 section 7.12)	Demonstrated equivalence to predicate devices
Radio-opacity (ISO 4049 section 7.14)	Demonstrated equivalence to predicate devices
E-Modulus (ISO 4049 section 7.11)	Demonstrated equivalence to predicate devices
Flexural strength (ISO 4049 section 7.11)	Demonstrated equivalence to predicate devices
Compressive strength (ISO 9917-1, AnnexD)	Demonstrated equivalence to predicate devices
Diametral tensile strength (ADA Spec. 27 section 4.3.7)	Demonstrated equivalence to predicate devices
Shade consistency (ANSI ADA Spec. 80)	Demonstrated equivalence to predicate devices
Color stability (ISO 4049 and ANSI ADA Spec. 80)	Demonstrated equivalence to predicate devices
Biocompatibility (ISO 10993 family, OECD 487)	Comparable to other materials on the market

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated for each bench test. These are material property tests typically performed on a specified number of samples (e.g., 5-10 per test for ISO standards), but the exact counts are not detailed in this summary.
Data Provenance: The tests are "non-clinical performance testing" or "bench testing" conducted by Kettenbach GmbH & Co KG in Germany, following international (ISO) and national (ASTM, ADA) standards. This is laboratory data, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for these physical and chemical property tests is established by adhering to standardized test methodologies and measurements, not by expert consensus on clinical findings.

4. Adjudication method for the test set

Not applicable. This refers to consensus building for clinical ground truth, which is not relevant for bench testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a material science study, not an AI-based diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a material science study, not an AI-based algorithm.

7. The type of ground truth used

For the non-clinical performance tests: The "ground truth" is the objective measurement of physical and chemical properties of the material according to established international and national standards (e.g., ISO, ASTM, ADA). For biocompatibility, established biological safety parameters are used as ground truth.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this type of material science evaluation. The evaluation involves testing the device itself against established standards and comparing its properties to predicate devices.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three overlapping profiles facing to the right.

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)

Page 1 of___1__

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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
1. PL-Core and PL-Core X can be applied with bondings for which the use with dualcuring composites is recommended
1. 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	LuxacoreDual	MulticoreFlow	Rebilda DC	Product	Visalys® Core	LuxacoreDual	MulticoreFlow	Rebilda DC
Manufacturer	KettenbachGmbH	DMG GmbH	IvoclarVivadent AG	Voco GmbH	Manufacturer	KettenbachGmbH	DMG GmbH	lvoclarVivadent AG	Voco GmbH
Productdescription	Visalys® Core,developed byKettenbach, is a dual-curing, fluoride-	Luxacore-Dual is anautomatic mixing,dual cure compositethat has beenspecially developedfor all types of corebuild-ups and build-up fillings.RadiopaqueLuxacore-Dualstands out due to itshigh compressivestrength, and it cutslike dentin. Thecuring time can beself-determined dueto additional lightcuring. It is possibleto apply Luxacore-Dual directly usingthe Intra-oral-Tip andEndo-Tip.	MultiCore Flow is adual-curing,radiopaquecomposite containingfluoride fillers thatdemonstratesexcellent mechanicalproperties for corebuild-ups. It cureschemically withoutthe use of light. Light-curing is optional.MultiCore Flow isavailable in a double-barrel cartridge or adouble-push syringewith automixing tipsfor fabricating corebuild-ups usingmatrices.	Rebilda DC is a dual-curing, highlyradiopaque flowablecomposite withexcellent mechanicalproperties for corebuild-up. Rebilda DCis available in threedifferent shades tocover a large rangeof indications: Blue tovisualize thetransition betweenmaterial and toothsubstance, especiallyin molar and pre-molar areas; dentinshade for highaesthetic de-mands,e.g. under fullceramic restorationsor composite resto-rations with hightranslucency; whiteas a possibility tovisualize preparationmargins an simulta-neously meetaesthetic demands.	AvailableShades	Dentin, White, Blue	A3. White, Blue	Medium, Light,White, Blue	Dentin, White, Blue
Indication	Different Types ofcore build-ups; Lutingof root posts	All types of corebuild-up;Cementation of root-posts	Core build-up of vitaland non-vital teeth;Adhesivecementation of glassfibre-reinforcedendodontic posts	Adhesive Core build-up of vital and non-vital teeth; Luting offibre-reinforced resin-posts	Applicationsystem	25 ml Sulzer 2Kcartridge5 ml Sulzer 2Ksyringe	25 ml Sulzer 2Kcartridge5 ml Sulzer 2Ksyringe	25 ml Sulzer 2Kcartridge5 ml Sulzer 2Ksyringe	25 ml Sulzer 2Kcartridge5 ml Sulzer 2Ksyringe
Storagetemperature	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.

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
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.(b)
Classification. Class II.