(59 days)
TopCEM-Veneer Light Cure Veneer Cement is used for permanent cementation of veneer made from materials of porcelain/ceramic and composites.
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.
The provided text is an FDA 510(k) summary for a dental cement (TopCEM-Veneer Light Cure Veneer Cement). It describes the device, its intended use, and bench testing performed to demonstrate substantial equivalence to predicate devices.
However, the request asks for information about acceptance criteria and a study proving a device meets these criteria, specifically in the context of an AI/ML-enabled medical device performance study. The document supplied does not describe an AI/ML-enabled device or any studies involving human readers, AI assistance, or ground truth establishment by experts. Instead, it describes a conventional material science device (dental cement) and its testing against physical and chemical properties standards (ISO 4049, ISO 29022).
Therefore, I cannot extract the requested information (such as AI/ML specific acceptance criteria, sample size for test/training sets in an AI context, expert qualifications, MRMC studies, standalone algorithm performance, or ground truth establishment for AI models) from the provided text. The document refers only to "bench testings" of physical and chemical properties.
Response based on the provided document:
The provided document describes the acceptance criteria and study for a dental cement, not an AI/ML-enabled medical device. Therefore, many of the requested categories related to AI/ML device performance studies (e.g., number of experts, adjudication methods, MRMC studies, standalone AI performance, training/test set details for AI) are not applicable and are not present in the text.
Here's an attempt to answer the relevant parts based only on the provided text, while explicitly stating when information is not applicable or not provided for an AI/ML context.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / Parameter) | Reported Device Performance (Conclusion) |
|---|---|
| ISO 4049 (5.2.2) Film thickness, luting materials: ≤ 50 µm | Satisfactory |
| ISO 4049 (5.2.7) Sensitivity to ambient light: Remain physically homogeneous | Satisfactory |
| ISO 4049 (5.2.8) Depth of cure: ≥ 1 mm (opaque) or ≥ 1.5 mm (other) | Satisfactory |
| ISO 4049 (5.2.9) Flexural strength: ≥ 50 MPa | Satisfactory |
| ISO 4049 (5.2.10) Water sorption: ≤ 40 µg/mm³ | Satisfactory |
| ISO 4049 (5.2.10) Solubility: ≤ 7.5 µg/mm³ | Satisfactory |
| ISO 4049 (5.5) Radio-opacity: ≥ same thickness of aluminium (1 mm of material) | Satisfactory |
| Shear bond strength (ISO 29022) | Meet internal standards |
| Bonding durability (ISO 29022) | Meet internal standards |
| Compressive strength | Meet internal standards |
| Elastic modulus | Meet internal standards |
| Surface hardness | Meet internal standards |
| Filler particle size distribution | Meet internal standards |
| Curing time | Meet internal standards |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in terms of specific number of samples tested for each criterion. The document states "Bench testings were performed on the subject device and the predicate devices."
- Data Provenance: Not specified in terms of country of origin for the testing data. The submitter is Rizhao HuGe Biomaterials Company, Ltd., China. The tests refer to international standards (ISO).
- Retrospective or Prospective: Not applicable for this type of material bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the study is not based on expert interpretation of medical images or data requiring "ground truth" establishment by human experts in the context of an AI/ML device. The "ground truth" here is determined by compliance with material properties standards (e.g., a film thickness measurement must be ≤ 50 µm).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept typically applies to human reader studies or expert consensus for AI/ML ground truth, which is not described here.
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
- No, this was not done. The device is a dental cement, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" or reference for the physical and chemical properties tests is established by international standards (ISO 4049, ISO 29022) and FDA guidance for dental composite resin devices. The "ground truth" is adherence to predefined physical/chemical limits.
8. The sample size for the training set
- Not applicable. This device is a physical material, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As stated above, this is a physical material tested against standards, not an AI/ML model with a training set.
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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).
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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
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
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)
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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 |
| 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 BiomaterialsCompany, 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
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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 perISO 4049/ISO 29022 | Pass/fail criteria | Conclusion |
| ISO 40495.2.2 Film thickness, lutingmaterials | The film thickness of luting materials in any event shall beno greater than 50 µm. | Satisfactory |
| ISO 40495.2.7 Sensitivity to ambientlight | When tested, the material shall remain physicallyhomogeneous. | Satisfactory |
| ISO 40495.2.8 Depth of cure | The depth of cure of Class 2 restorative materials shall beno less than 1 mm if they are labelled by the manufactureras opaque, or no less than 1.5 mm for other restorativematerials. | Satisfactory |
| ISO 40495.2.9 Flexural strength | The flexural strength shall be equal to or greater than 50MPa. | Satisfactory |
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| ISO 40495.2.10 Water sorption andsolubility | The water sorption shall be ≤ 40 $\mu$ g/mm³.The solubility of shall be ≤ 7.5 $\mu$ g/mm³. | Satisfactory |
|---|---|---|
| ISO 40495.5 Radio-opacity | The radio-opacity shall be equal to or greater than that ofthe same thickness of aluminium (1 mm of material). | Satisfactory |
| Shear bond strength(The test methods refer to theISO 29022) | Meet internal standards. | Satisfactory |
| Bonding durability(The test methods refer to theISO 29022) | Meet internal standards. | Satisfactory |
| Compressive strengthElastic modulusSurface hardnessFiller particle size distributionCuring 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 | |||
|---|---|---|---|
| TechnologicalCharacteristics | 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 isused for permanentcementation of veneer madefrom materials ofporcelain/ceramic andcomposites. | Permanent adhesive lutingof glass-ceramic, lithiumdisilicate glass-ceramic andcomposite restorations(inlays, onlays and veneers)Only use Variolink EstheticLC for restorations with alow thickness of <2mm thathave sufficient translucency(e.g. restorations made ofIPS e.max R HT). | Dual Cure Resin Cement is adental luting system designedfor cementation of all sorts ofdental restorations includingcrowns, bridges,inlays/onlays, veneers, dentalposts and other restorationsmade from materials ofmetals/alloys, metal-ceramic,all-ceramic and/or porcelain,composites, and theircombinations. |
| Prescription/over-the-counter use | Prescription | Prescription | Prescription |
| Delivery form | Packed in syringes | Packed in syringes | Packed in syringes |
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| TechnologicalCharacteristics | Subject device | Primary predicate | Secondary Predicate |
|---|---|---|---|
| RadiographicAppearance | Radiopaque | Radiopaque | Radiopaque |
| PhysicalProperties | The subject device and the predicate devices have substantially equivalent physicalproperties as they all conform to ISO 4049, ISO 29022 and FDA guidance “Guidance forIndustry 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
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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.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)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.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. 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.(2)
Classification. Class II.