(59 days)
No reference device was used in this submission.
No
The device description and performance studies focus on the material properties and physical performance of a dental cement, with no mention of AI or ML technologies.
No
This product is a dental cement used for permanent cementation of veneers, which is a material for bonding, not a therapeutic device designed to treat or cure a disease or medical condition.
No
Explanation: The device is a light-curing cement system used for permanent cementation of veneers. Its function is to facilitate the bonding of dental restorations, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a "visible light curing cementation system" with "principal organic components" and "inorganic filler loading," indicating it is a physical material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "permanent cementation of veneer made from materials of porcelain/ceramic and composites." This describes a material used in the body for a structural purpose, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a "visible light curing cementation system" with specific chemical components and physical properties. This aligns with a dental restorative material, not a diagnostic test.
- Performance Studies: The performance studies focus on material properties like "Film thickness, Sensitivity to ambient light, Depth of cure, Flexural strength, Water sorption and solubility, Radio-opacity, Shear bond strength, Bonding durability, Compressive strength, Elastic modulus, Surface hardness, Filler particle size distribution, and Curing time." These are all relevant to the physical and mechanical performance of a dental cement, not the accuracy or reliability of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
Therefore, TopCEM-Veneer Light Cure Veneer Cement is a dental material used for restoration, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
TopCEM-Veneer Light Cure Veneer Cement is used for permanent cementation of veneer made from materials of porcelain/ceramic and composites.
Product codes (comma separated list FDA assigned to the subject device)
EMA, EBF
Device Description
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.
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 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.
Key results:
ISO 4049 5.2.2 Film thickness, luting materials: Satisfactory (The film thickness of luting materials in any event shall be no greater than 50 µm.)
ISO 4049 5.2.7 Sensitivity to ambient light: Satisfactory (When tested, the material shall remain physically homogeneous.)
ISO 4049 5.2.8 Depth of cure: Satisfactory (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.)
ISO 4049 5.2.9 Flexural strength: Satisfactory (The flexural strength shall be equal to or greater than 50 MPa.)
ISO 4049 5.2.10 Water sorption and solubility: Satisfactory (The water sorption shall be ≤ 40 µg/mm³. The solubility of shall be ≤ 7.5 µg/mm³.)
ISO 4049 5.5 Radio-opacity: Satisfactory (The radio-opacity shall be equal to or greater than that of the same thickness of aluminium (1 mm of material).)
Shear bond strength (The test methods refer to the ISO 29022): Satisfactory (Meet internal standards.)
Bonding durability (The test methods refer to the ISO 29022): Satisfactory (Meet internal standards.)
Compressive strength, Elastic modulus, Surface hardness, Filler particle size distribution, Curing time: Satisfactory (Meet internal standards.)
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.
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.
No reference device was used in this submission.
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
§ 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.
0
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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).
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)
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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4
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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 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 |
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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 |