(146 days)
"Hyramic CAD/CAM Restorative" is used for dental restorations, such as full crowns, inlays/onlays and veneers.
"Hyramic CAD/CAM Restorative" consists of inorganic filler and polymer material to form a homogeneous solid block material. The inorganic filler is derived from glass powders, while the resin is derived from methacrylate co-polymer (UDMA,TEGDMA、 and BisGMA). The formed blocks have a microstructure of inorganic materials embedded in a highly cured resin matrix. The unique combination of the two materials creates a uniform hybrid, which lends the positive physical properties of each individual material to the other. The material has been processed through various molding techniques – into their final net shapes. These blanks are then further fabricated into various prosthetic dental devices intended for use in the production of dental restorations such as full crowns, inlays/onlays and veneers. "Hyramic CAD/CAM Restorative" is hybrid ceramic/resin dental blanks designed for the manufacture of dental prosthetic devices. The dental prosthetic devices are fabricated by CAD/CAM machining processes. All prosthetic dental devices are intended for single use applications. At the dental lab, the blanks are held to the CAD/CAM machine which is used to machine to the final dental restoration. Unlike conventional ceramic restorations, customization and glaze firing is not necessary for Hyramic CAD/CAM Restorative. "Hyramic CAD/CAM Restorative" is supplied in different shapes, such as blocks, discs, rods, or customer ordered shapes. It is also supplied in the combinations of twenty one different colors, two different translucencies, and two different aesthetic effects (single and multilayer).
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria, structured according to your requested information.
It's important to note that this document is a 510(k) Summary. 510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical efficacy studies akin to what might be required for a novel device or a PMA. Therefore, the information might not align perfectly with what one would expect for a complex AI/software medical device.
Key takeaway: This document describes a traditional dental material (Tooth Shade Resin Material) and not an AI or software device. As such, many of the questions related to AI-specific elements (like MRMC studies, AI improvement, standalone algorithm performance, training set details) are not applicable. The "device" here is a physical material for dental restorations.
1. A table of acceptance criteria and the reported device performance
Based on the document, the acceptance criteria are primarily derived from the ISO 10477 standard for "Dentistry - Polymer-based crown and bridge material." Specific numerical acceptance criteria are not explicitly listed in this summary, but the general statement is that "All tests were verified to meet acceptance criteria." and "results met all relevant requirements in the test standard."
| Feature/Test | Acceptance Criteria | Reported Device Performance (Hyramic CAD/CAM Restorative) |
|---|---|---|
| Mechanical Properties | ||
| Flexural Strength | Per ISO 10477 | "very similar to the predicate device" (and predicate met ISO 10477 requirements) |
| Water Absorption | Per ISO 10477 | "very similar to the predicate device" (and predicate met ISO 10477 requirements) |
| Solubility in Water | Per ISO 10477 | "very similar to the predicate device" (and predicate met ISO 10477 requirements) |
| Biocompatibility | ||
| Biocompatibility tests | Per ISO 10993 | "met all relevant requirements in the test standards, and are comparable to the predicate device." |
2. Sample sized used for the test set and the data provenance
The document does not specify the sample sizes used for the mechanical or biocompatibility tests. It also does not explicitly state the provenance of the data in terms of country of origin or whether it was retrospective or prospective, beyond stating that testing was performed. These are bench tests on material samples, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a physical dental material, and the "ground truth" for its performance is established through standardized laboratory testing (e.g., measuring flexural strength, water absorption), not by expert interpretation of data.
4. Adjudication method for the test set
This question is not applicable, as there's no expert interpretation or consensus involved in establishing the "ground truth" for material properties.
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
This question is not applicable. The device is a physical dental restoration material, not an AI or software algorithm that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is not an algorithm.
7. The type of ground truth used
The ground truth for the performance of the "Hyramic CAD/CAM Restorative" is established through standardized laboratory measurements and physical property testing as defined by ISO 10477 and ISO 10993. This is akin to "benchmark" data for material science, not clinical pathology or outcomes data.
8. The sample size for the training set
This question is not applicable. There is no concept of a "training set" for a physical dental material like this. The material is manufactured, and its properties are then tested.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this type of device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 12, 2017
Liaoning Upcera Co.,ltd Charles Shen Official Correspondent Manton Business and Technology Services 37 Winding Ridge Oakland, New Jersey 07436
Re: K162323
Trade/Device Name: Tooth Shade Resin Material Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: August 17, 2016 Received: December 13, 2016
Dear Charles Shen:
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 (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. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Susan Runno DDS, MA
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162323
Device Name "Hyramic CAD/CAM Restorative"
Indications for Use (Describe)
"Hyramic CAD/CAM Restorative" is used for dental restorations, such as full crowns, inlays/onlays and veneers.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5: 510(k) Summary:
This 510(k) Summary is being submitted in accordance with the requirements of 21CFR 807.92
5.1 Submitter & Foreign Manufacture Identification
Liaoning Upcera Co., Ltd No.122 Xianghuai Road, Economic Development Zone, Benxi, Liaoning, China Tel: (086)-24-45565006 Submitter's FDA Registration Number: 3010582952 www.upcera-dental.com
5.2 Contact Person
Charles Shen Manton Business and Technology Services 37 Winding Ridge, Oakland, NJ 07436 Tel: 608-217-9358 Email: cyshen@aol.com
5.3 Date of Summary: January 11, 2017
5.4 Device Name:
| Proprietary Name: | Hyramic CAD/CAM Restorative |
|---|---|
| Common Name: | Dental material, filling/restorative, polymer based |
| Classification Name: | Tooth Shade Resin Material |
| Classification Regulation: | 21 CFR 872.3690 |
| Product Code: | EBF |
| Class: | Class 2 |
| Panel: | Dental |
ર્સ્ટ Predicate Device Information:
The "Hyramic CAD/CAM Restorative" described in this premarket notification are substantially equivalent to:
K110131, "Lava Ultimate CAD/CAM Restorative", manufactured by "3M (1) Company", at St. Paul, MN
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5.6 Device Description:
"Hyramic CAD/CAM Restorative" consists of inorganic filler and polymer material to form a homogeneous solid block material. The inorganic filler is derived from glass powders, while the resin is derived from methacrylate co-polymer (UDMA,TEGDMA、 and BisGMA). The formed blocks have a microstructure of inorganic materials embedded in a highly cured resin matrix. The unique combination of the two materials creates a uniform hybrid, which lends the positive physical properties of each individual material to the other.
The material has been processed through various molding techniques – into their final net shapes. These blanks are then further fabricated into various prosthetic dental devices intended for use in the production of dental restorations such as full crowns, inlays/onlays and veneers. The performance of formed Hyramic CAD/CAM Restorative conforms to ISO 10477. Dentistry - Polymer-based crown and bridge material.
"Hyramic CAD/CAM Restorative" is hybrid ceramic/resin dental blanks designed for the manufacture of dental prosthetic devices. The dental prosthetic devices are fabricated by CAD/CAM machining processes. All prosthetic dental devices are intended for single use applications. At the dental lab, the blanks are held to the CAD/CAM machine which is used to machine to the final dental restoration. Unlike conventional ceramic restorations, customization and glaze firing is not necessary for Hyramic CAD/CAM Restorative.
"Hyramic CAD/CAM Restorative" is supplied in different shapes, such as blocks, discs, rods, or customer ordered shapes. It is also supplied in the combinations of twenty one different colors, two different translucencies, and two different aesthetic effects (single and multilayer).
The different colors are originated from the different constituent of color additives; the different translucencies are originated from different content of BisGMA, and the different method used in the process of molding.
5.7 Indications for Use:
"Hyramic CAD/CAM Restorative" is used for dental restorations, such as full crowns, inlays/onlays and veneers.
5.8 Summary of Device Testing:
Bench testing was performed per ISO 10477:2004 and internal procedures to ensure that the "Hyramic CAD/CAM Restorative" met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalence of the materials that are used.
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5.9 Technological Comparison with Predicate Device
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
| Description | Subject Device | Predicate Device (K110131) |
|---|---|---|
| Indication for Use | "Hyramic CAD/CAM Restorative" is used for dental restorations, such as full crowns, inlays/onlays and veneers. | The product is indicated for inlays, onlays, veneers, and full crown restorations, including crowns on implants. |
| Basic Design | Blocks, disc, and rod | Blocks, disc, and rod |
| Materials | Glass powder, Copolymer of UMDA, TEGDMA, and BisGMA | SiO2, ZrO2, Copolymer of SiO2, ZrO2, Copolymer of UMDA, TEGDMA, BisEMA, and BisGMA |
| Microstructure | Resin-ceramic composite | Resin-ceramic composite |
| Processing | Mixed at room temperature and cured at elevated temperatures | Mixed at room temperature and cured at elevated temperatures |
| Curing Mechanism | Heat Induced | Heat Induced |
| Dimension | Various | Various |
| Single Use | Yes | Yes |
| Feature | Twenty one colors, two translucencies, and two aesthetic effects | Various colors and translucencies |
| Sterile | Non-sterile | Non-sterile |
| Table 5.1: Comparison of Intended Use. Design, Material, and Processing | |||
|---|---|---|---|
Our device is essentially identical to the predicate device in terms of indications for use, design, material, and processing between our device and the predicate devices. The minor differences do not raise any safety and efficacy concerns.
Comparison of Performance with Predicate Device 5.10
Performance testing was performed on the subject device and results were compared with predicate device. Tests were conducted following applicable procedures outlined in the FDA recognized consensus standard of ISO 10477, and results met all relevant requirements in the test standard. Test results on flexural strength, water absorption, and solubility in water of the subject device are very similar to the predicate device.
Biocompatibility tests were conducted following the recommended procedures outlined in the FDA recognized consensus standard of ISO 10993, and results from the subject
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device met all relevant requirements in the test standards, and are comparable to the predicate device.
Substantial Equivalence Conclusion 5.11
It has been shown in this 510(k) submission that "Hyramic CAD/CAM Restorative" and its predicate devices have the identical indications for use, similar composition and biocompatibility, similar manufacturing process, and similar performance.
The difference between the "Hyramic CAD/CAM Restorative" and their predicate device do not raise any question regarding its equivalence.
"Hyramic CAD/CAM Restorative", as designed and manufactured, is equivalent to its predicate device, and therefore is substantially equivalent as its predicate device.
§ 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.