K Number

Device Name

Visalys Restorative Primer

Manufacturer

Kettenbach GmbH & Co. KG

Date Cleared

2019-10-09

(121 days)

Product Code

KLE DEV

Regulation Number

872.3200

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K150703

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the chemical composition and physical properties of a dental primer, with no mention of AI or ML.

Therapeutic

No.
The "Intended Use / Indications for Use" states that the device is a "Restoration primer for treatment of: metal/silicate ceramics, oxide ceramic and composite surfaces" specifically "to cement prosthetic restorations" and "to repair fractured restorations with composite materials." This indicates it's used for preparing surfaces for adhesion, not for treating a disease or condition. Its function is to facilitate the bonding of dental materials, which is a restorative rather than therapeutic purpose.

Diagnostic

Explanation: The device is described as a "Restoration primer" used for "building up adhesive surfaces on restoration materials." Its intended use is to "cement prosthetic restorations" and "repair fractured restorations with composite materials." This indicates it is a material used in restorative dental procedures, not for diagnosing conditions.

SaMD (Software as a Medical Device)

The device description clearly indicates it is a chemical primer composed of adhesive monomers, which is a physical substance, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for restoring and repairing dental prosthetic restorations by treating the surfaces of various materials (metal, ceramics, composite). This is a direct application to materials used in the mouth, not for testing samples taken from the body.
Device Description: The description details a primer with adhesive monomers for building up adhesive surfaces on restoration materials. This aligns with a dental restorative product, not a diagnostic test.
Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.), detecting specific analytes, or providing information for diagnosis, monitoring, or treatment decisions based on biological samples.
Performance Studies: The performance studies focus on physical properties like shear bond strength on restorative materials and biocompatibility, which are relevant to dental materials, not diagnostic tests.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for medical purposes. This device's function is to prepare surfaces for dental restorations, which is a therapeutic/restorative application, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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

Product codes (comma separated list FDA assigned to the subject device)

KLE

Device Description

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)

The following in vitro bench tests were performed on the Visalys® Restorative Primer to verify physical properties and performance in support of substantial equivalence:

. Shear Bond strength on restorative materials acc. to ISO 16506 "Dentistry -Polymer-based luting materials containing adhesive component shear bond strength test" (Chapter A 2.2.5).
The performance of the Visalys® Restorative 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® Restorative Primer, universal adhesion primer for restoration materials 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.

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.

K150703

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

Regulation Number and Section

§ 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.

Summary

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 and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 9, 2019

Kettenbach GmbH & Co. KG Katja Simon Regulatory Affairs Manager Im Heerfeld 7 35713 Eschenburg, Germany

Re: K191523

Trade/Device Name: Visalys Restorative Primer Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: September 4, 2019 Received: September 9, 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 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,

for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K191523

Device Name Visalys® Restorative Primer

Indications for Use (Describe)

Restoration primer for treatment of:

metal/silicate ceramics, oxide ceramic and composite surfaces

· to cement prosthetic restorations
· to repair fractured restorations with composite materials

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 shows the logo for KETTENBACH. The logo consists of 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 is the slogan "Simply intelligent" in a smaller, bold font. To the right of the blue square, there is a circled "R" symbol, indicating a registered trademark.

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:

September 04th, 2019

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. Underneath "KETTENBACH", the phrase "Simply intelligent" is written in a smaller, sans-serif font.

B. Device Identification: Device Trade Name: Common Name:

Visalys® Restorative Primer

Visalys® Restorative Primer Universal adhesion primer for restoration materials

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.:

CLEARFIL™ CERAMIC PRIMER PLUS Kuraray Noritake Dental Inc. K150703

D. Device Description:

E. Indications for 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

Image /page/5/Picture/0 description: The image shows the logo for KETTENBACH. The logo consists of a blue square with six white circles arranged in a triangular shape. Below the square, the word "KETTENBACH" is written in white, followed by the tagline "Simply intelligent devices" in black. There is also a registered trademark symbol in the upper right corner of the blue square.

F. Comparison of technological characteristic with the predicate devices

	Predicate Devices	Substantial Equivalent Device	Conclusion
Product	CLEARFIL™ CERAMIC PRIMER PLUS	Visalys® Restorative Primer
Manufacturer	Kuraray Noritake Dental Inc.	Kettenbach GmbH & Co. KG
510(k)
numbers	K150703	K191523
Product
Description	CLEARFIL™ CERAMIC PRIMER PLUS is a
dental universal prosthetic primer that
provides an enhanced adhesive surface to
ceramic (e.g. conventional porcelain, lithium
disilicate, zirconia), hybrid ceramics (e.g.
ESTENIA C&B), composite resin and metal.	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 that does not have to be light-cured.	Similar
Indication for
use	Indications:
CLEARFIL™ CERAMIC PRIMER PLUS is
indicated for the following uses:
[1] Surface treatment of prosthetic
restorations made of ceramic, hybrid
ceramics, composite resin or metal
[2] Intraoral repairs of fractured restorations
made of ceramics, hybrid ceramics,
composite resin or metal	Indications:
Restoration primer for treatment of
metal/silicate ceramics, oxide ceramic and
composite surfaces
• to cement prosthetic restorations
• to repair fractured restorations with composite
materials	Similar
Storage
temperature	2 – 8 °C/36 – 46 °F	2 – 8 °C/35 – 46 °F	Similar
Application
system	Bottle	Bottle	Similar
Composition	• 3-Methacryloxypropyl trimethoxysilane
• 10-Methacryloyloxydecyl dihydrogen
phosphate (MDP)
• Ethanol	The main components of the Visalys®
Restorative Primer are
ethanol, acidic adhesive monomer (10-MDP)
and silane methacrylate.	Similar
	Predicate Devices	Simply intelligent
Substantial Equivalent Device	Conclusion
Product	CLEARFIL™ CERAMIC PRIMER PLUS	Visalys® Restorative Primer
Manufacturer	Kuraray Noritake Dental Inc.	Kettenbach GmbH & Co. KG
510(k) numbers	K150703	K191523
Shear bond strengths on different restorative materials
(ISO 16506 / Chapter A 2.2.5):
Lithium
disilicate	(8.9 MPa)	(10.2 MPa)	Similar
Zirconium
oxide	(8.4 MPa)	(7.5 MPa)	Similar
Non-precious
metal	(8.3 MPa)	(12.5 MPa)	Similar
Products used
in the testing	CLEARFIL™ Ceramic Primer Plus
(K150703) was tested with the resin
product Panavia V5 dental cement
(K150704), manufactured by Kuraray	Visalys® Restorative Primer (K191523)
was tested with the resin product Visalys
CemCore (K191527), manufactured by
Kettenbach GmbH & Co. KG.
Product description and composition for the predicate device has been extracted from the instruction for use. Values given in brackets
have been determined by Kettenbach

Image /page/6/Picture/0 description: The image shows the logo for KETTENBACH. The logo consists of a blue square with six white circles arranged in a triangular pattern at the top. Below the circles is the word "KETTENBACH" in white, and below that is the phrase "Simply intelligent" in black. There is also a registered trademark symbol in the upper right corner.

Table 1: Visalys® Restorative Primer product description and characteristic to predicate device

Image /page/7/Picture/0 description: The image shows the logo for Kettenbach GmbH & Co. KG. The logo features a blue square with a white graphic of six circles arranged in a triangular shape at the top. Below the graphic, the word "KETTENBACH" is written in white, followed by the tagline "Simply intelligent" in black.

G. Technological Characteristics Summary:

Visalys® Restorative Primer is considered substantially equivalent to Clearfil Ceramic Primer Plus. There is no significant difference in intended use or technology. Therefore Visalys® Restorative 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® Restorative Primer to verify physical properties and performance in support of substantial equivalence:

. Shear Bond strength on restorative materials acc. to ISO 16506 "Dentistry -Polymer-based luting materials containing adhesive component shear bond strength test" (Chapter A 2.2.5).
The performance of the Visalys® Restorative Primer satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence.

Rationale for using ISO 16506 (Chapter A 2.2.5) as test standard

The Medical Device Product Classification for the stated product is KLE (Agent, Tooth Bonding, Resin). However, the stated product Visalys® Restorative Primer acts as a coupling agent between restoration material (e.g. ceramics, metals) and luting material (e.g. Visalys® CemCore) and not between luting material and tooth structure. For the later indication, Visalys® Tooth Primer can be used. The recognized test standards ISO 29022 and ISO/TS 11405 as well as ISO/TS 16506 describe different bonding strength measurements. Unfortunately, all three standards only show methods to determine bond strength to tooth structure. As no product-specific standard exists for the subject device, testing was conducted under ISO/TS 16506 due to the following reason:

Shear bond strength is described in ISO 29022 and in ISO/TS 16506. The main difference is the loading of the test specimen after application of the luting material in ISO/TS 16506 (force of 150 N ± 2N, Ch 7.5.1.2), whereas no force is applied in the test method described in ISO 29022. Visalys® Restorative Primer is used on restorations such as crowns, bridges, inlays and onlays. After applying a luting material on the restoration, it is placed in the patient's mouth onto a tooth,

Image /page/8/Picture/0 description: The image is a logo for KETTENBACH. The logo is set against a blue square background. The logo consists of seven white circles arranged in a triangular shape, with six circles forming the base and one circle at the apex. Below the circles, the word "KETTENBACH" is written in bold, white letters. Below the word, the phrase "Simply intelligent" is written in black letters.

core or into a cavity by applying a force onto the restoration to maintain a small laver thickness of the luting material. Therefore, the shear bond test method described in ISO/TS 16506 is a more realistic measurement for this kind of product (Visalys® Restorative Primer) due to the loading of the test specimen, which simulates the above-mentioned clinical procedure. ISO/TS 11405 gives a general overview of techniques for examination of adhesion. Once aqain, only procedures for testing of the adhesion to tooth structure are included (title of the standard: "Testing of adhesion to tooth structure"). Annex A describes methods for the measurement of bond strength. As explained above, shear bond strength of Visalys® Restorative Primer was already tested according to ISO/TS 16506. An additional bond strength measurement is e.g. micro-tensile bond strength, as described in Annex A, A.2.4. Unfortunately, such measurement cannot be performed with restorative materials because there is no practicable way to cut restorative materials (e.g. metals like titanium) into the desired dimension of 1 mm x 1 mm. Additionally, no force can be applied on the luting material to simulate the clinical procedure (see above). For a detailed description of micro-tensile bond strength and the challenging test procedure to prepare test specimen, see S. Armstrong et al. (1)

Armstrong, S. et al. Academy of Dental Materials quidance on in vitro 1. testing of dental composite bonding effectiveness to dentin / enamel using microtensile bond strength (µTBS) approach. Dent. Mater. 33, 133-143 (2016).

-Clinical Performance Data

No data from human clinical studies has been included to support the substantial equivalence of Visalys® Restorative Primer.

J. Conclusion Regarding Substantial Equivalence:

Kettenbach GmbH & Co KG believes that Visalys® Restorative Primer, universal adhesion primer for restoration materials is substantially equivalent to Clearfil Ceramic Primer Plus (K150703). It does not introduce new indications for use, has similar technological characteristics and does not introduce new potential hazards or safety risks.