TopCEM Ceramic Primer Ceramic Coupling Agent
Device Facts
| Record ID | K242749 |
|---|---|
| Device Name | TopCEM Ceramic Primer Ceramic Coupling Agent |
| Applicant | Rizhao Huge Biomaterials Company, Ltd. |
| Product Code | KLE · Dental |
| Decision Date | Nov 8, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3200 |
| Device Class | Class 2 |
Indications for Use
TopCEM Ceramic Primer Ceramic Coupling Agent serves as priming agent and is used to create a durable adhesion between luting composites and glass/oxide ceramic, metal, composite and fiberreinforced composite restorations.
Device Story
TopCEM Ceramic Primer Ceramic Coupling Agent is a liquid dental auxiliary material used to facilitate bonding between dental prostheses and resin adhesives. It is applied to the surface of restorations (glass/oxide ceramic, metal, composite, fiber-reinforced composite) to create a bonding layer. The device is used in the oral cavity by dental professionals. It functions via a silane coupling agent, acid acrylate, and volatile organic solvent composition; it polymerizes in situ when used in conjunction with a resin cement. The device does not contact tooth tissue directly. It improves the bonding effect between the prosthesis and the luting composite, potentially increasing the longevity and stability of dental restorations.
Clinical Evidence
No clinical data. Substantial equivalence is supported by non-clinical bench testing, including stability testing, physical property analysis (appearance, solid content, bond strength, infrared characteristic peaks), and biocompatibility analysis per ISO 7405 and ISO 10993 standards.
Technological Characteristics
Liquid dental primer composed of silane coupling agent, acid acrylate, and volatile organic solvent. Curing mechanism: polymerization with resin cement. Delivery: bottle. Biocompatibility: compliant with ISO 7405 and ISO 10993. No electronic or software components.
Indications for Use
Indicated for use as a priming agent to create durable adhesion between luting composites and glass/oxide ceramic, metal, composite, and fiber-reinforced composite dental restorations.
Regulatory Classification
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.
Predicate Devices
- MONOBOND PLUS (K090826)
Reference Devices
Submission Summary (Full Text)
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November 8, 2024
Rizhao HuGe Biomaterials Company, Ltd. Maggie Zheng Regulatory Affairs Manager No.2 North Zhaoyang Road, District of Donggang Rizhao City, 276800 CHINA
Re: K242749
Trade/Device Name: TopCEM Ceramic Primer Ceramic Coupling Agent Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE, EMA Dated: September 12, 2024 Received: September 12, 2024
Dear Maggie Zheng:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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-regulatory
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assistance/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,
# Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT 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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### Indications for Use
Submission Number (if known)
K242749
Device Name
TopCEM Ceramic Primer Ceramic Coupling Agent
Indications for Use (Describe)
TopCEM Ceramic Primer Ceramic Coupling Agent serves as priming agent and is used to create a durable adhesion between luting composites and glass/oxide ceramic, metal, composite and fiberreinforced composite restorations.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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## K242749 510 (k) Summary
This summary of 510(k) for the subjective device equivalence information is being submitted in accordance with the requirements of 21 C.F.R. 807.92.
### 1. Date Summary Prepared: October 29, 2024
### 2. Submitter Information:
| Owner's Name | Rizhao HuGe Biomaterials Company, Ltd. |
|----------------|-------------------------------------------------------------------------------------------------|
| Address | No.2 North Zhaoyang Road, District of Donggang, Rizhao City,<br>Shandong Province, China 276800 |
| Telephone | 0086 633 2277268 |
| Fax | 0086 633 2277298 |
| Contact Person | Ms. Maggie Zheng |
| Contact Title | Regulatory Affairs Manager |
| E-mail | zhengxy@hugedent.com |
### 3. Device Name
Trade name: TopCEM Ceramic Primer Ceramic Coupling Agent Common name: Ceramic Coupling Agent Classification name: Agent, Tooth Bonding, Resin (21 CFR 872.3200) Regulatory Class: II Product Code: KLE, EMA
### 4. Predicate Device Information
| Owner/Operator | Device Trade Name | 510 (k) No. | Product Code | Device Type |
|-------------------------------------------|------------------------|-------------|--------------|-------------|
| IVOCLAR VIVADENT,<br>INC. | MONOBOND PLUS | K090826 | KLE | Predicate |
| IVOCLAR VIVADENT,<br>INC. | Monobond Etch & Prime | K150164 | KLE | Reference |
| Rizhao HuGe Biomaterials<br>Company, Ltd. | Dual Cure Resin Cement | K201790 | EMA, EBF | |
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In addition to the predicate device, Monobond Etch & Prime (K150164) and Dual Cure Resin Cement (K201790) are included as reference devices in support of substantial equivalence. The main reason for inclusion of the reference devices, is to support similarities and safety in composition of materials to the subject device, and the other items are not included in the comparison table between the reference devices and the other two devices accordingly. The predicate devices have not been subject to a design-related recall.
### 5. Description of Device
TopCEM Ceramic Primer Ceramic Coupling Agent is common oral cementation repair auxiliary materials. In the process of using the product, TopCEM Ceramic Primer Ceramic Coupling Agent is placed between the prosthesis and resin adhesives, which can form the bonding layer of tooth tissue - light cure dental adhesive layer - resin cement layer - ceramic coupling agent - prosthesis, so as to achieve better bonding effect. TopCEM Ceramic Primer Ceramic Coupling Agent does not have direct contact with tooth tissue during use.
TopCEM Ceramic Primer Ceramic Coupling Agent is mainly composed of silane coupling agent, acid acrylate and volatile organic solvent.
### 6. Indications for Use
TopCEM Ceramic Primer Ceramic Coupling Agent serves as priming agent and is used to create a durable adhesion between luting composites and glass/oxide ceramic, metal, composite and fiber-reinforced composite restorations.
### 7. Technological Characteristics Comparison
All components of the subject device are based upon industry well-known chemistry. The curing mechanism is achieved through polymerization together with a resin cement.The following table shows the significant technological characteristics for the subject device and indicates the following similarities and differences with the predicate and reference devices.
| Technological Characteristics Comparison Table | | | | |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Technological<br>Characteristics | Subject device<br>K242749 | Predicate device<br>K090826 | Reference<br>device<br>K150164 | Reference<br>device<br>K201790 |
| Composition<br>of Materials | It is mainly composed of<br>silane coupling agent,<br>acid acrylate and volatile | It is mainly composed of<br>silane coupling agent,<br>acid acrylate and volatile | It is mainly<br>composed of<br>ceramic etching | 1. Monomer<br>matrix:<br>Methacrylate |
| Technological Characteristics Comparison Table | | | | |
| Technological<br>Characteristics | Subject device<br>K242749 | Predicate device<br>K090826 | Reference<br>device<br>K150164 | Reference<br>device<br>K201790 |
| | organic solvent. | organic solvent. | agent, silane<br>coupling agent,<br>acid acrylate and<br>volatile organic<br>solvent. | based<br>2. Primary<br>Filler(s):<br>Silanated<br>Barium glass<br>filler |
| Physical Form | Liquid | Liquid | / | / |
| Indications for Use | TopCEM Ceramic<br>Primer Ceramic<br>Coupling Agent serves as<br>priming agent and is<br>used to create a durable<br>adhesion between luting<br>composites and<br>glass/oxide ceramic,<br>metal, composite and<br>fiber-reinforced<br>composite restorations. | Monobond Plus serves<br>as bonding agent and is<br>used to create a durable<br>chemical bond between<br>luting composites and<br>glass/oxide ceramic,<br>metal, composite and<br>fiber-reinforced<br>composite restorations. | / | / |
| Clinical condition | Priming of dental<br>restorations | Priming of dental<br>restorations | / | / |
| Contact with human<br>body | Oral cavity | Oral cavity | / | / |
| Prescription/over-<br>the-counter use | Prescription | Prescription | / | / |
| Method of use | Film forming | Film forming | / | / |
| Curing mechanism | Be polymerized together<br>with a resin cement. | Be polymerized together<br>with a resin cement. | / | / |
| Delivery form | Bottle | Bottle | / | / |
| Physical Properties | The subject device and the predicate device have<br>substantially equivalent physical properties as they<br>all conform to Internal standard SOP of the company. | | / | / |
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# UHF
All compositions of the subject device are based upon industry well-known chemistry. The technological characteristics of the subject device are very similar to those of the predicate device. The subject device is a similar product, manufactured with similar materials and used in
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the same way by the same types of users and patient populations. The subject device and predicate device have minor difference in Composition of Materials. However, the difference does not affect the intended use or substantial equivalence. Besides, other comparison items such as physical form, curing mechanism, delivery form and physical properties, etc. are the same or very similar. And both of the subject device and the predicate device are supplied for prescription use.
### 8. Summary of Non-clinical testing
Through accelerated and real-time stability testing, the subject device is reliable and effective within 2 years.
The physical properties of the subject device, including Appearance, Solid Content, Bond Strength (MPa), Whether there are traces left on the glass panel surface, Packing Amount Tolerance and Detection of Infrared Characteristic Peaks, were determined and tested according to Internal standard SOP of the company, and the test results demonstrated the qualification and substantial equivalence when compared to the predicate device.
The subject device is substantially equivalent to the predicate device that has been legally marketed for years and with no clinical adverse events. The compositions of the subject device do not contain any non-conventional chemicals compared to the legally marketed predicate device. Through biocompatibility analysis, it can be concluded that the subject device is in compliance with the ISO 7405 and ISO 10993 standards.
### 9. Summary of Clinical testing
Clinical test is not applicable.
### 10. Conclusions
Based on the indications for use, technological characteristics, performance testing and comparison to the predicate device, the subject device has been shown to be safe and effective for its intended use and the minor differences in composition of the predicate device affecting neither the general intended use nor substantial equivalence. Rizhao HuGe Biomaterials Company, Ltd. concludes that the subject device is substantially equivalent to the predicate device described herein.
