(113 days)
No
The device description and intended use focus on the physical properties and function of a gel for color evaluation, with no mention of AI or ML technologies.
No.
The device is used to evaluate the shade and matching of a dental restoration before permanent cementation, indicating its function as a diagnostic or evaluative aid rather than one that treats or prevents a disease or condition.
No
The device is a try-in gel used to evaluate the shade and matching of dental restorations for aesthetic purposes, not to diagnose a disease or condition.
No
The device description clearly states it is a gel made of physical components (polyethylene glycol, inorganic fillers, pigments) and is used for physical color evaluation, not software processing or analysis.
Based on the provided information, it is highly likely that this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "evaluate the shade and the matching of the restoration prior to permanent cementation." This is a visual assessment of a dental restoration (veneer) against the patient's tooth, not a test performed in vitro on a biological sample to diagnose a condition or provide information about a physiological state.
- Device Description: The description focuses on the chemical composition and how it functions as a temporary color indicator. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or prognosis of a disease or condition
- Providing information about a physiological or pathological state
The device's function is purely to aid in the aesthetic selection of a dental material by simulating its final color. This falls under the category of a dental material or accessory, not an in vitro diagnostic device.
The predicate and reference devices listed (Variolink Esthetic Try-In and 3M RelyX Veneer Cement Try-in Paster) are also consistent with this assessment, as they are known dental try-in pastes used for similar purposes.
N/A
Intended Use / Indications for Use
TopCEM-Try in Veneer Try-in Gel is used to evaluate the shade and the matching of the restoration prior to permanent cementation.
Product codes
EBF
Device Description
TopCEM-Try in Veneer Try-in Gel is primarily made of polyethylene glycol, inorganic fillers and pigments. It is used to indicate the color of the Light Cure Veneer Cement before use, so as to select the right color to achieve the best aesthetic effect. The polyethylene glycol and inorganic filler in the Veneer Try-in Gel component are hydrophilic and can be rinsed off with a water gun nozzle after the color test operation.
The principal organic components of TopCEM-Try in Veneer Try-in Gel are mixtures of polyethylene glycol, and the inorganic fillers loading is about 50% by volume.
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 physical properties of the subject device were determined and tested according to HuGe internal inspection standard. Bench testing was performed on the subject device and the primary predicate device, the test results demonstrated the substantial equivalence when compared to the primary predicate device.
Summary of Physical and Chemical Properties Test:
- Items per internal standards: Appearance, Shade, Liquidity, Consistence
- Pass/fail criteria: Meet internal standards.
- Conclusion: Satisfactory
Biocompatibility tests were performed fully following the ISO 10993 standards and the FDA guidance titled "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."" The test endpoint studies include cytotoxicity, sensitization, and irritation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
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December 20, 2024
Rizhao HuGe Biomaterials Company, Ltd. Maggie Zheng Regulatory Affairs Manager No.2 North Zhaoyang Road, District of Donggang Rizhao City, 276800 CHINA
Re: K242572
Trade/Device Name: TopCEM-Try in Veneer Try-in Gel Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: November 25, 2024 Received: November 25, 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 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-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)
Device Name
TopCEM-Try in Veneer Try-in Gel
Indications for Use (Describe)
TopCEM-Try in Veneer Try-in Gel is used to evaluate the shade and the matching of the restoration prior to permanent cementation.
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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K242572 - 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: December 16, 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-Try in Veneer Try-in Gel Common name: Veneer Try-in Gel Classification name: Material, Tooth Shade, Resin Regulation Number: 21 CFR 872.3690 Regulatory Class: II Product Code: EBF
4. Predicate Device Information
| Owner/Operator | Predicate Device Trade
Name | 510 (k)
No. | Product
Code | Classification
Name | Regulation
Number | Predicate |
|------------------------|-----------------------------------------|----------------|-----------------|---------------------------------|----------------------|-----------|
| Ivoclar Vivadent
AG | Variolink Esthetic Try-In | K142389 | EBF | Material, Tooth
Shade, Resin | 872.3690 | Primary |
| 3M Company | 3M RelyX Veneer Cement
Try-in Paster | K002452 | EMA | Cement, Dental | 872.3275 | Reference |
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5. Description of Device
TopCEM-Try in Veneer Try-in Gel is primarily made of polyethylene glycol, inorganic fillers and pigments. It is used to indicate the color of the Light Cure Veneer Cement before use, so as to select the right color to achieve the best aesthetic effect. The polyethylene glycol and inorganic filler in the Veneer Try-in Gel component are hydrophilic and can be rinsed off with a water gun nozzle after the color test operation.
The principal organic components of TopCEM-Try in Veneer Try-in Gel are mixtures of polyethylene glycol, and the inorganic fillers loading is about 50% by volume.
6. Indications for Use
TopCEM-Try in Veneer Try-in Gel is used to evaluate the shade and the matching of the restoration prior to permanent cementation.
7. Summary of Physical and Chemical Properties Tests
The physical properties of the subject device were determined and tested according to HuGe internal inspection standard. Bench testing was performed on the subject device and the primary predicate device, the test results demonstrated the substantial equivalence when compared to the primary predicate device.
| Summary of Physical and Chemical Properties Test | ||||||
|---|---|---|---|---|---|---|
| Items per internal standards | Pass/fail criteria | Conclusion | ||||
| Appearance | Meet internal standards. | Satisfactory | ||||
| Shade | Meet internal standards. | Satisfactory | ||||
| Liquidity | Meet internal standards. | Satisfactory | ||||
| Consistence | Meet internal standards. | Satisfactory |
8. Technological Characteristics Comparison
All components of the subject device are based upon industry well-known chemistry. The following table shows the significant technological characteristics for the subject device and indicates the following similarities and differences with the predicate devices:
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| Technological Characteristics Comparison Table | ||||
|---|---|---|---|---|
| Technological | ||||
| Characteristics | Subject device | |||
| TopCEM-Try in Veneer | ||||
| Try-in Gel | ||||
| (K242572) | Primary predicate device | |||
| Variolink Esthetic Try-in | ||||
| (K142389) | Reference predicate | |||
| device | ||||
| 3M RelyX Veneer | ||||
| Cement Try-in Paster | ||||
| (K002452) | ||||
| Main components | TopCEM-Try in Veneer | |||
| try-in gel is primarily made | ||||
| of polyethylene glycol, | ||||
| colorant, inorganic fillers | ||||
| and pigments. | The Variolink Esthetic | |||
| Try-In pastes contain | ||||
| glycerine, mineral fillers | ||||
| and inorganic fillers. | RelyX Try-In paste | |||
| contains polyethylene | ||||
| glycol (PEG), | ||||
| zirconia/silica filler and | ||||
| pigments. | ||||
| Physical Form | Paste | Paste | / | |
| Water solubility | Hydrophilic | Hydrophilic | / | |
| Indications of Use | TopCEM-Try in Veneer | |||
| Try-in Gel is used to | ||||
| evaluate the shade and the | ||||
| matching of the | ||||
| restoration prior to | ||||
| permanent cementation. | To evaluate the overall | |||
| effect of the restoration | ||||
| in conjunction with the | ||||
| various Variolink | ||||
| Esthetic shades prior to | ||||
| permanent cementation. | / | |||
| Prescription/over- | ||||
| the-counter use | Prescription | Prescription | / | |
| Delivery form | Packed in syringe | Packed in syringe | / | |
| Storage Condition | Store TopCEM-Try in | |||
| Veneer Try-in Gel at 2-25 | ||||
| °C and away from direct | ||||
| light. | Storage temperature: | |||
| 2-28 °C / 36-82 °F. | / | |||
| Physical Properties | The subject and the primary predicate device have | |||
| substantially equivalent physical properties as they all | ||||
| conform to HuGe internal inspection standard. | / |
The indications of the subject device are similar to that of 510(k) cleared primary predicate device. Based on the indications for use in comparison to primary predicate device, the subject device has demonstrated substantial equivalence to the predicate device.
Based on HuGe internal inspection standard, technological characteristics, physical properties, performance testing are carried to compare the subject device with primary predicate device. According to test results, the subject device has similar technological characteristics with the primary predicate device.
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9. Summarv of Biocompatibility
The subject device is substantially equivalent to the predicate devices. 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 and the FDA guidance titled "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."" The test endpoint studies include cytotoxicity, sensitization, and irritation.
10. Clinical Performance Data
Clinical test is not applicable.
11. Conclusions
Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the subject device has demonstrated substantial equivalence. The minor differences in indications for use between the subject and predicate device does not affect the general intended use or substantial equivalence. Rizhao HuGe Biomaterials Company, Ltd. concludes that the subject device is substantially equivalent to the predicate devices described herein.