(111 days)
Not Found
No
The summary describes a dental primer and its intended use and performance through bench testing and biocompatibility studies. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is a tooth primer used for permanent cementation and core build-ups of tooth structures, not for treating or curing a disease or condition.
No
The device, Visalys® Tooth Primer, is described as a self-etching single-component primer for adhesive bonding of dental materials for permanent cementation and build-ups. Its function is to prepare tooth structure for bonding, not to diagnose a medical condition.
No
The device description clearly indicates it is a chemical primer for dental bonding, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a primer for permanent cementation and build-up adhesive bonding of dental restorations and materials to tooth structure. This is a direct application to the patient's body for a therapeutic or restorative purpose.
- Device Description: The description details a self-etching single-component primer for adhesive bonding to dental hard substance. This is a material used in a dental procedure.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are used to test samples (like blood, urine, tissue) taken from the body to gain information about a person's health status. This device is applied to the body as part of a dental treatment.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
KLE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth structure, dental hard substance, enamel, dentin
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)
The following in vitro bench tests were performed on the Visalys® Tooth Primer to verify physical properties and performance in support of substantial equivalence:
- . Shear Bond strength on enamel and dentin according to ISO 29022 "Denistry -Adhesion - Notched edge shear bond strength test"
The performance of the Visalys® Tooth Primer satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence.
Biocompatibility tests have been performed to assure biological safety in accordance with the ISO 10993 family and ISO 7405. Tests in respect of cytotoxicity (ISO 10993-5), mutagenicity (OECD 487), sensitization (ISO 10993-10) and a chemical analysis (10993-18) showed, that Visalys® Tooth Primer, self-etching single component primer for the tooth hard substance's biocompatibility data is comparable or superior to the predicate device. Therefore no toxicological risks and resulting hazards for patients, users and third parties can be concluded.
No data from human clinical studies has been included to support the substantial equivalence of Visalys® Tooth Primer.
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
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 29, 2019
Kettenbach GmbH & Co. KG Katja Simon Regulatory Affairs Manager Im Heerfeld 7 Eschenburg, 35713 Germany
Re: K191524
Trade/Device Name: Visalys Tooth Primer Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: August 27, 2019 Received: August 30, 2019
Dear Katja 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Srinivas Nandkumar Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K191524
Device Name Visalys® Tooth Primer
Indications for Use (Describe)
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
Type of Use (Select one or both, as applicable)
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image features the logo for KETTENBACH, a company whose slogan is "Simply intelligent". The logo consists of a blue square with the company name in white, stacked on top of the slogan, which is in black. Above the company name is a graphic of six white circles arranged in a triangular shape. To the right of the blue square is the registered trademark symbol.
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.com
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
Date of preparation:
August 26th, 2019
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Image /page/4/Picture/0 description: The image contains the logo for KETTENBACH. The logo features a blue square with six white circles arranged in a triangular pattern at the top. Below the circles, the word "KETTENBACH" is written in a bold, sans-serif font, also in white. Underneath "KETTENBACH," the tagline "Simply intelligent" is displayed in a smaller, black, sans-serif font. To the right of the blue square, there is a circled "R" symbol, indicating a registered trademark.
Visalvs® Tooth Primer B. Device Identification:
Device Trade Name: Common Name:
Visalys® Tooth Primer self-etching single component primer for the tooth hard substance
Classification of the device:
Device Classification Name: Product Code: Device Classification No.: Panel: Requlatory Status:
Resin tooth bonding agent KLE Part 872.3200 Dental Class II
C. Predicate device:
Device Trade Name: Applicant: 510(k) No.:
Panavia™ V5 Tooth Primer Kuraray Noritake Dental Niigata Plant K150704
D. 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.
E. Indications for 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-up
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Image /page/5/Picture/0 description: The image shows the logo for Kettenbach. The logo consists of a blue square with the word "KETTENBACH" in white letters at the bottom. Above the word is a symbol of seven white circles arranged in a triangular shape. Below the blue square are the words "Simply intelligent" in black letters.
F. Comparison of technological characteristic with the predicate devices
| Predicate Devices | Substantial Equivalent Device | Conclusion | |
|---|---|---|---|
| Product | Panavia V5 TOOTH PRIMER | Visalys® Tooth Primer | |
| Manufacturer | Kuraray | Kettenbach GmbH & Co. KG | |
| 510(k) | K150704 | K191524 | |
| Product Description | The Tooth Primer is a self-etching primer to tooth | ||
| structure that | |||
| accelerates the polymerization of the Paste | 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. Visalys® Tooth Primer does not | |||
| have to be cured with light. | Similar | ||
| Indications for use | PANAVIA V5 is indicated for the following uses: | ||
| [1] Cementation of crowns, bridges, inlays and onlays | |||
| [2] Cementation of veneers | |||
| [3] Cementation of adhesion bridges and splints | |||
| [4] Cementation of prosthetic restorations on implant | |||
| abutments and frames | |||
| [5] Cementation of posts and cores | |||
| [6] Amalgam bonding | For permanent cementation of tooth structure to: | ||
| • crowns, bridges, inlays, onlays, 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 | Similar | ||
| Storage temperature | 2-8°C/36-46°F | /2-8°C/36-46°F | Similar |
| Application system | Bottle | Bottle | Similar |
| A comparison of parameters in respect to processing time/mechanical properties was performed. The results demonstrated the substantial equivalence to the | |||
| predicate device. |
Table 1: Visalys® Tooth Primer product description and characteristic to predicate device
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Image /page/6/Picture/0 description: The image is a logo for Kettenbach. The logo features a blue square with six white circles arranged in a triangular pattern at the top. Below the circles, the word "KETTENBACH" is written in a bold, sans-serif font. Underneath the company name, the tagline "Simply intelligent" is displayed in a smaller, less bold font. To the right of the blue square, there is a circled "R" symbol, indicating a registered trademark.
G. Technological Characteristics Summary:
Visalys® Tooth Primer is considered substantially equivalent to Panavia V5 Tooth Primer. There is no significant difference in intended use or technology. Therefore Visalys® Tooth Primer is substantially equivalent to the above listed predicate device. Differences in respect to chemical composition and resulting mechanical and physical properties have been evaluated.
H. Summary of Non-Clinical Performance Testing:
The following in vitro bench tests were performed on the Visalys® Tooth Primer to verify physical properties and performance in support of substantial equivalence:
- . Shear Bond strength on enamel and dentin according to ISO 29022 "Denistry -Adhesion - Notched edge shear bond strength test"
The performance of the Visalys® Tooth Primer satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence.
Biocompatibility tests have been performed to assure biological safety in accordance with the ISO 10993 family and ISO 7405. Tests in respect of cytotoxicity (ISO 10993-5), mutagenicity (OECD 487), sensitization (ISO 10993-10) and a chemical analysis (10993-18) showed, that Visalys® Tooth Primer, self-etching single component primer for the tooth hard substance's biocompatibility data is comparable or superior to the predicate device. Therefore no toxicological risks and resulting hazards for patients, users and third parties can be concluded.
I. Clinical Performance Data
No data from human clinical studies has been included to support the substantial equivalence of Visalys® Tooth Primer.
J. Conclusion Regarding Substantial Equivalence:
Kettenbach GmbH & Co KG believes that Visalys® Tooth Primer, self-etching single component primer for the tooth hard substance is substantially equivalent to Panavia V5 tooth primer (K150704). It does not introduce new indications for use, has similar technological characteristics and does not introduce new potential hazards or safety risks.
The fact that the indication for use for Visalys® Tooth Primer does not include bonding to amalgam does not interfere with the substantial equivalency to the predicate device, Panavia V5 tooth primer (K150704) since by international convention, usage of mercurycontaining dental amalgam is to be reduced. Likewise, it was not tested (Press Release U.S. Department of State. PRN: 2013/1353.