(147 days)
Not Found
No
The device description focuses on the material composition and physical properties of a dental core build-up material, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a dental core build-up material used for structural restoration, not for treating a disease or condition. Its purpose is to physically restore the tooth structure.
No
Explanation: The device, Visalys® Core / PL-Variants, are described as dual-curing core build-up materials intended for core build-ups and luting of root posts. This indicates a restorative or structural purpose, not a diagnostic one. The performance studies focus on mechanical properties and biocompatibility, which are relevant for materials used in treatment, not for identifying diseases or conditions.
No
The device description clearly indicates it is a dual-curing core build-up material, which is a physical substance (composite) used in dental procedures. It also describes delivery systems like cartridges and syringes, further confirming it is a hardware/material device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "different types of core build-ups and luting of root posts." This describes a material used in the mouth for dental restoration procedures.
- Device Description: The description details a "dual-curing core build-up material" which is a composite used for dental fillings and core build-ups. It is applied directly to the tooth.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of biological samples or diagnostic purposes.
The device is a dental material used for restorative procedures, not for in vitro diagnostic testing.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
EBF
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, 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 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:
-
- Visalys® Core and PL-Core C are compatible with all common light and dualcuring adhesives available on the market
-
- PL-Core and PL-Core X can be applied with bondings for which the use with dualcuring composites is recommended
-
- Radiopacity is available in 2.5mm Al (Visalys® Core and PL-Core-X) or 2.0mm Al (PL-Core-C and PL-Core)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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) ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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__
3
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:
4
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 |
5
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.
6
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:
-
- Visalys® Core and PL-Core C are compatible with all common light and dualcuring adhesives available on the market
-
- PL-Core and PL-Core X can be applied with bondings for which the use with dualcuring composites is recommended
-
- 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
7
| Product | Visalys® Core | Luxacore
Dual | Multicore
Flow | Rebilda DC | Product | Visalys® Core | Luxacore
Dual | Multicore
Flow | Rebilda DC |
|------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|
| Manufacturer | Kettenbach
GmbH | DMG GmbH | Ivoclar
Vivadent AG | Voco GmbH | Manufacturer | Kettenbach
GmbH | DMG GmbH | lvoclar
Vivadent AG | Voco GmbH |
| Product
description | Visalys® Core,
developed by
Kettenbach, is a dual-
curing, fluoride-
| Luxacore-Dual is an
automatic mixing,
dual cure composite
that has been
specially developed
for all types of core
build-ups and build-
up fillings.
Radiopaque
Luxacore-Dual
stands out due to its
high compressive
strength, and it cuts
like dentin. The
curing time can be
self-determined due
to additional light
curing. It is possible
to apply Luxacore-
Dual directly using
the Intra-oral-Tip and
Endo-Tip. | MultiCore Flow is a
dual-curing,
radiopaque
composite containing
fluoride fillers that
demonstrates
excellent mechanical
properties for core
build-ups. It cures
chemically without
the use of light. Light-
curing is optional.
MultiCore Flow is
available in a double-
barrel cartridge or a
double-push syringe
with automixing tips
for fabricating core
build-ups using
matrices. | Rebilda DC is a dual-
curing, highly
radiopaque flowable
composite with
excellent mechanical
properties for core
build-up. Rebilda DC
is available in three
different shades to
cover a large range
of indications: Blue to
visualize the
transition between
material and tooth
substance, especially
in molar and pre-
molar areas; dentin
shade for high
aesthetic de-mands,
e.g. under full
ceramic restorations
or composite resto-
rations with high
translucency; white
as a possibility to
visualize preparation
margins an simulta-
neously meet
aesthetic demands. | Available
Shades | Dentin, White, Blue | A3. White, Blue | Medium, Light,
White, Blue | Dentin, White, Blue |
| Indication | Different Types of
core build-ups; Luting
of root posts | All types of core
build-up;
Cementation of root-
posts | Core build-up of vital
and non-vital teeth;
Adhesive
cementation of glass
fibre-reinforced
endodontic posts | Adhesive Core build-
up of vital and non-
vital teeth; Luting of
fibre-reinforced resin-
posts | Application
system | 25 ml Sulzer 2K
cartridge
5 ml Sulzer 2K
syringe | 25 ml Sulzer 2K
cartridge
5 ml Sulzer 2K
syringe | 25 ml Sulzer 2K
cartridge
5 ml Sulzer 2K
syringe | 25 ml Sulzer 2K
cartridge
5 ml Sulzer 2K
syringe |
| Storage
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
8
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.
9
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.