Who is the manufacturer of TopCEM-Veneer Light Cure Veneer Cement?

Rizhao Huge Biomaterials Company, Ltd. filed the 510(k) submission for TopCEM-Veneer Light Cure Veneer Cement (K241204).

What is the FDA product code for TopCEM-Veneer Light Cure Veneer Cement?

EMA. It is classified under 21 CFR 872.3275 as a Class 2 device in the Dental panel.

What is the regulatory pathway for TopCEM-Veneer Light Cure Veneer Cement?

510(k) clearance (submission type: Traditional).

What are the predicate devices for TopCEM-Veneer Light Cure Veneer Cement?

Variolink Esthetic LC (K142389); Dual Cure Resin Cement (K201790).

Who can help prepare an FDA 510(k) submission like TopCEM-Veneer Light Cure Veneer Cement?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TopCEM-Veneer Light Cure Veneer Cement

K241204 · Rizhao Huge Biomaterials Company, Ltd. · EMA · Jun 28, 2024 · Dental

Device Facts

Record ID	K241204
Device Name	TopCEM-Veneer Light Cure Veneer Cement
Applicant	Rizhao Huge Biomaterials Company, Ltd.
Product Code	EMA · Dental
Decision Date	Jun 28, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3275
Device Class	Class 2
Attributes	Therapeutic

Intended Use

TopCEM-Veneer Light Cure Veneer Cement is used for permanent cementation of veneer made from materials of porcelain/ceramic and composites.

Device Story

TopCEM-Veneer Light Cure Veneer Cement is a visible light-curing dental cementation system. It consists of a mixture of methacrylate resins (TEGDMA, EBP ADMA, UDMA) and inorganic fillers (0.01-5 microns). The device is supplied in syringes and is intended for professional use by dentists in a clinical setting. The clinician applies the paste to the veneer restoration; polymerization is triggered by an external light-curing energy source. The cement is radiopaque, allowing for radiographic identification. By providing a stable, durable bond between the tooth structure and the veneer, the device restores dental function and aesthetics. It is designed for use with porcelain, ceramic, and composite materials.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing according to ISO 4049 (film thickness, sensitivity to ambient light, depth of cure, flexural strength, water sorption/solubility, radiopacity) and ISO 29022 (shear bond strength, bonding durability). Biocompatibility testing was performed per ISO 10993, including cytotoxicity, sensitization, systemic toxicity, subchronic toxicity, and genotoxicity.

Technological Characteristics

Methacrylate-based resin matrix (TEGDMA, EBP ADMA, UDMA); inorganic filler loading ~40% vol (0.01-5 µm). Visible light-curing polymerization. Radiopaque. Form factor: syringe-delivered paste. Conforms to ISO 4049 (Type 2, Class 2, Group 1) and ISO 29022. No software or electronic components.

Indications for Use

Indicated for permanent cementation of porcelain/ceramic and composite veneers in patients requiring dental restoration.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Predicate Devices

Variolink Esthetic LC (K142389)
Dual Cure Resin Cement (K201790)

Related Devices

K210504 — PANAVIA Veneer LC · Kuraray Noritake Dental, Inc. · Jun 11, 2021
K191389 — Allcem Veneer APS · Dentscare Ltda · Feb 25, 2020
K073101 — AURAVENEER CEMENT · Denali Corporation · Jan 17, 2008
K111836 — PERMASHADE VENEER CEMENT · Ultradent Products, Inc. · Sep 16, 2011
K180649 — BeautiCem Veneer Kit · Shofu Dental Corporation · Jun 11, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a solid blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it. June 28, 2024 Rizhao HuGe Biomaterials Company, Ltd. Maggie Zheng Regulatory Affairs Manager No.2 North Zhaoyang Road, District of Donggang Rizhao Citv. 276800 China Re: K241204 Trade/Device Name: TopCEM-Veneer Light Cure Veneer Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA, EBF Dated: April 30, 2024 Received: April 30, 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. 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). {1}------------------------------------------------ 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 OS 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. 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 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, Bobak Shirmohammadi -S For Michael E. Adjodha, M.ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices {2}------------------------------------------------ Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K241204 Device Name TopCEM-Veneer Light Cure Veneer Cement Indications for Use (Describe) TopCEM-Veneer Light Cure Veneer Cement is used for permanent cementation of veneer made from materials of porcelain/ceramic and composites. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "HUGE" in large, bold, orange letters. The letters are sans-serif and appear to be a modern font. A thin black line underlines the word, emphasizing its size and impact. The background is plain white, making the orange letters stand out prominently. ## K241204 # 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: May 23, 2024 ### 2. Submitter Information: | Owner's Name | Rizhao HuGe Biomaterials Company, Ltd. | |----------------|-------------------------------------------------------------------------------------------------| | Address | No.2 North Zhaoyang Road, District of Donggang, Rizhao City, 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-Veneer Light Cure Veneer Cement Common name: Light Cure Veneer Cement Classification name: Material, Tooth Shade, Resin (21 CFR 872.3690) Regulatory Class: II Product Code: EBF, EMA #### 4. Predicate Device Information | Owner/Operator | Device Trade Name | 510 (k) No. | Product Code | Predicate | |-------------------------------------------|------------------------|-------------|--------------|-----------| | Ivoclar Vivadent AG | Variolink Esthetic LC | K142389 | EBF | Primary | | Rizhao HuGe Biomaterials Company, Ltd. | Dual Cure Resin Cement | K201790 | EMA, EBF | Secondary | These predicate devices have not been subject to a design-related recall. No reference device was used in this submission. #### 5. Description of Device {5}------------------------------------------------ TopCEM-Veneer Light Cure Veneer Cement is a visible light curing cementation system that is designed for use with porcelain/ceramic and composite veneer restorations. The simple and versatile shade selections allow this material to be used with a wide range of veneer cases. The principal organic components are mixtures of dental methacrylate resins (TEGDMA, EBP ADMA and UDMA). The inorganic filler loading is about 40% by volume having particle size range of about 0.01 to 5 microns. Light Cure Veneer Cement is radiopaque, allowing for easy identification on radiographs. It is classified as Type 2 Class 2 Group 1 in accordance with ISO 4049:2019, which belongs to materials whose use requires the energy to be applied intro-orally. ### 6. Indications for Use TopCEM-Veneer Light Cure Veneer Cement is used for permanent cementation of veneer made from materials of porcelain/ceramic and composites. ### 7. Summary of Physical and Chemical Properties Tests The subject device belongs to Type 2 Class 2 Group 1 materials in accordance with ISO 4049. The physical properties of the subject device were determined and tested according to ISO 4049, ISO 29022 and FDA guidance "Guidance for Industry and FDA Staff Dental Composite Resin Devices - Premarket Notification [510(k)]Submissions Document issued on: October 26, 2005". Bench testings were performed on the subject device and the predicate devices, the test results demonstrated the substantial equivalence when compared to the predicate devices. | Summary of Physical and Chemical Properties Test | | | |-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Items per ISO 4049/ISO 29022 | Pass/fail criteria | Conclusion | | ISO 4049 5.2.2 Film thickness, luting materials | The film thickness of luting materials in any event shall be no greater than 50 µm. | Satisfactory | | ISO 4049 5.2.7 Sensitivity to ambient light | When tested, the material shall remain physically homogeneous. | Satisfactory | | ISO 4049 5.2.8 Depth of cure | The depth of cure of Class 2 restorative materials shall be no less than 1 mm if they are labelled by the manufacturer as opaque, or no less than 1.5 mm for other restorative materials. | Satisfactory | | ISO 4049 5.2.9 Flexural strength | The flexural strength shall be equal to or greater than 50 MPa. | Satisfactory | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "HUGE" in large, bold, orange letters. The letters are sans-serif and appear to be a modern font. A thin, black line underlines the word, adding a sense of emphasis and grounding to the design. The overall impression is one of simplicity and directness, with the bright color and large size drawing immediate attention. | ISO 4049 5.2.10 Water sorption and solubility | The water sorption shall be ≤ 40 $\mu$ g/mm³. The solubility of shall be ≤ 7.5 $\mu$ g/mm³. | Satisfactory | |-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------| | ISO 4049 5.5 Radio-opacity | The radio-opacity shall be equal to or greater than that of the same thickness of aluminium (1 mm of material). | Satisfactory | | Shear bond strength (The test methods refer to the ISO 29022) | Meet internal standards. | Satisfactory | | Bonding durability (The test methods refer to the ISO 29022) | Meet internal standards. | Satisfactory | | Compressive strength Elastic modulus Surface hardness Filler particle size distribution Curing time | Meet internal standards. | Satisfactory | ### 8. Technological Characteristics Comparison All components of the subject device are based upon industry well-known chemistry. The curing mechanism of the subject device and predicate devices are polymerization of uncured methacrylate ester monomers. The subject device's reaction is caused by photo initiator. The following table shows the significant technological characteristics for the subject device and indicates the following similarities and differences with the predicate devices: | Technological Characteristics Comparison Table | | | | |------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technological Characteristics | Subject device | Primary predicate | Secondary Predicate | | Monomer matrix | Methacrylate based | Methacrylate based | Methacrylate based | | Physical Form | Paste | Paste | Paste | | Indications of Use | Light Cure Veneer Cement is used for permanent cementation of veneer made from materials of porcelain/ceramic and composites. | Permanent adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays and veneers) Only use Variolink Esthetic LC for restorations with a low thickness of <2mm that have sufficient translucency (e.g. restorations made of IPS e.max R HT). | Dual Cure Resin Cement is a dental luting system designed for cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, metal-ceramic, all-ceramic and/or porcelain, composites, and their combinations. | | Prescription/over- the-counter use | Prescription | Prescription | Prescription | | Delivery form | Packed in syringes | Packed in syringes | Packed in syringes | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "HUGE" in large, bold, orange letters. The letters are stacked on top of each other, taking up most of the image. A thin black line is located directly underneath the word. | Technological Characteristics | Subject device | Primary predicate | Secondary Predicate | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---------------------| | Radiographic Appearance | Radiopaque | Radiopaque | Radiopaque | | Physical Properties | The subject device and the predicate devices have substantially equivalent physical properties as they all conform to ISO 4049, ISO 29022 and FDA guidance “Guidance for Industry and FDA Staff Dental Composite Resin Devices - Premarket Notification [510(k)]Submissions Document issued on: October 26, 2005”. | | | The indications of the subject device are all covered by that of the 510(k) cleared predicate devices. Based on the indications for use in comparison to predicate devices, the subject device has been shown to be safe and effective for its intended use, and the minor differences in indications for use fall within the intended use of the predicate devices affecting neither the general intended use nor substantial equivalence. Based on ISO 4049 Dentistry - Polymer-Based Restorative Materials, ISO 29022 Dentistry -Adhesive - Notched-edge sheer bond strength test and Dental Composite Resin Devices -Premarket Notification [ 510(k)] Submissions, technological characteristics, physical properties, performance testing are carried to compare the subject device with predicate devices. According to test results, the subject device has similar technological characteristics with the predicate devices. #### 9. Summary of Biocompatibility The subject device is substantially equivalent to the predicate devices that have 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 devices. Biocompatibility tests were performed fully following the ISO 10993 standards. The test items include Cytotoxicity, Sensitization, Systemic Toxicity, Subchronic Toxicity and Genotoxicity. #### 10. Clinical Performance Data Clinical test is not applicable. #### 11. Conclusions {8}------------------------------------------------ # HUGE Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the subject device has been shown to be safe and effective for its intended use and the minor differences in indications for use fall within the intended use of the predicate devices 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 devices described herein.