(121 days)
Restoration primer for treatment of:
metal/silicate ceramics, oxide ceramic and composite surfaces
- · to cement prosthetic restorations
- · to repair fractured restorations with composite materials
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Visalys® Restorative Primer device.
It's important to note that this document is a 510(k) summary for a Class II medical device (Resin Tooth Bonding Agent). For such devices, the FDA often relies on substantial equivalence to a predicate device, which means direct comparative effectiveness studies with human subjects against the predicate might not always be required in the same way as for novel high-risk devices. The information provided is primarily focused on demonstrating this substantial equivalence through bench testing.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly derived from the bond strength values of the predicate device, CLEARFIL™ CERAMIC PRIMER PLUS (K150703). The study aims to show that Visalys® Restorative Primer performs similarly. No explicit "acceptance criteria" are stated as numerical thresholds; rather, the "Similar" conclusion in the table below serves as the acceptance.
| Test Parameter / Material | Predicate Device Performance (CLEARFIL™ CERAMIC PRIMER PLUS) | Visalys® Restorative Primer Performance | Acceptance Criteria (Implicit) | Conclusion |
|---|---|---|---|---|
| Shear Bond Strength (MPa) | Similar performance to predicate | |||
| Lithium disilicate | (8.9 MPa) | (10.2 MPa) | Achieving comparable shear bond strength | Similar |
| Zirconium oxide | (8.4 MPa) | (7.5 MPa) | Achieving comparable shear bond strength | Similar |
| Non-precious metal | (8.3 MPa) | (12.5 MPa) | Achieving comparable shear bond strength | Similar |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not explicitly state the number of samples or specimens used for the shear bond strength tests. It only lists the resulting bond strength values.
- Data Provenance: The study was conducted by Kettenbach GmbH & Co. KG (located in Eschenburg, Germany). The data is prospective as it involves new bench testing to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a dental primer, and the ground truth for its performance (shear bond strength) is established through in vitro bench testing according to a recognized standard (ISO 16506). This does not involve human expert adjudication of images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as the evaluation is based on objective physical measurements (shear bond strength) from bench tests, not on subjective expert consensus or adjudication.
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 device is a dental primer, not an AI-based diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental primer, not an algorithm. The performance evaluation presented is strictly standalone in vitro bench testing of the product's physical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the device's performance is established by objective physical measurements (shear bond strength) obtained through standardized in vitro bench testing adhering to relevant ISO standards (specifically, ISO 16506 Chapter A 2.2.5).
8. The sample size for the training set
Not applicable. This is a physical dental product, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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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 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.
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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 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
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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
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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. 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:
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.
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
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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 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 | |
| ProductDescription | CLEARFIL™ CERAMIC PRIMER PLUS is adental universal prosthetic primer thatprovides an enhanced adhesive surface toceramic (e.g. conventional porcelain, lithiumdisilicate, zirconia), hybrid ceramics (e.g.ESTENIA C&B), composite resin and metal. | Visalys® Restorative Primer with adhesivemonomers (10-MDP, silane methacrylate) isfor building up adhesive surfaces onrestoration materials (metal, composite, as wellas silicate and oxide ceramics). Visalys®Restorative Primer is a single componentprimer that does not have to be light-cured. | Similar |
| Indication foruse | Indications:CLEARFIL™ CERAMIC PRIMER PLUS isindicated for the following uses:[1] Surface treatment of prostheticrestorations made of ceramic, hybridceramics, composite resin or metal[2] Intraoral repairs of fractured restorationsmade of ceramics, hybrid ceramics,composite resin or metal | Indications:Restoration primer for treatment ofmetal/silicate ceramics, oxide ceramic andcomposite surfaces• to cement prosthetic restorations• to repair fractured restorations with compositematerials | Similar |
| Storagetemperature | 2 – 8 °C/36 – 46 °F | 2 – 8 °C/35 – 46 °F | Similar |
| Applicationsystem | Bottle | Bottle | Similar |
| Composition | • 3-Methacryloxypropyl trimethoxysilane• 10-Methacryloyloxydecyl dihydrogenphosphate (MDP)• Ethanol | The main components of the Visalys®Restorative Primer areethanol, acidic adhesive monomer (10-MDP)and silane methacrylate. | Similar |
| Predicate Devices | Simply intelligentSubstantial 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): | |||
| Lithiumdisilicate | (8.9 MPa) | (10.2 MPa) | Similar |
| Zirconiumoxide | (8.4 MPa) | (7.5 MPa) | Similar |
| Non-preciousmetal | (8.3 MPa) | (12.5 MPa) | Similar |
| Products usedin the testing | CLEARFIL™ Ceramic Primer Plus(K150703) was tested with the resinproduct Panavia V5 dental cement(K150704), manufactured by Kuraray | Visalys® Restorative Primer (K191523)was tested with the resin product VisalysCemCore (K191527), manufactured byKettenbach GmbH & Co. KG. | |
| Product description and composition for the predicate device has been extracted from the instruction for use. Values given in bracketshave been determined by Kettenbach |
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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
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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.
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.
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,
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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.
§ 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.