(65 days)
New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) are intended for use with CAD/CAM technology to produce all ceramic dental restorations (full contour crowns, bridges, inlays, and Veneers) as prescribed by a dentist.
New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded) are derived from Zirconia powder that has been processed into their final net shapes. These blanks are then further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/ onlay. The zirconia powder is composed of ZrO2 + Y2O3 + HfO2 + A12O2. The performance of the dental blanks conforms to ISO 6872: 2008, Dentistry: Ceramic Materials. The shading effects of New Century All-Ceramic Dental Zirconia Blocks (Pre-Shaded) are achieved by blending different zirconia powder material, all from the same supplier; have almost identical composition, differing only in the trace amount of inorganic pigments to achieve the shading effects in dental blanks. The performance of the preshaded dental zirconia blanks also conforms to ISO 6872, Dentistry: Ceramic Materials.
The provided text describes a 510(k) premarket notification for "New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)". This is a submission for a medical device used in dentistry, specifically for CAD/CAM technology to produce dental restorations. It is not a submission for an AI/ML device.
Therefore, most of the questions regarding acceptance criteria, study design for AI devices, sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance are not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device (K140070 Luxer Shaded Zirconia) based on non-clinical performance testing and technological comparison.
However, I can extract the information that is present in the document which relates to performance and criteria.
1. A table of acceptance criteria and the reported device performance:
The document states that bench testing was performed per ISO 6872:2008 and using internal testing procedures (for presintered and sintered density) to ensure that the device met specifications. It explicitly mentions:
"All tests were verified to meet acceptance criteria."
The specific acceptance criteria from ISO 6872:2008 are not detailed in the provided text, but the document confirms compliance. The device also underwent a biocompatibility assessment in accordance with ISO 10993-1.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 6872:2008 (Dentistry: Ceramic Materials) requirements for physical and mechanical properties | Met specifications; all tests verified to meet acceptance criteria. |
| Internal testing procedures for presintered and sintered density | Met specifications; all tests verified to meet acceptance criteria. |
| ISO 10993-1 (Biocompatibility assessment) | A biocompatibility assessment was conducted in accordance with ISO 10993-1. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the non-clinical bench tests. The tests were performed "per ISO 6872:2008 and using internal testing procedures." The provenance of the data is implied to be from the manufacturer, Shanghai New Century Dental Materials Co., Ltd. in China, as they performed the tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as it is not an AI/ML device requiring clinical expert ground truth for interpretation. The "ground truth" here refers to the measured physical and mechanical properties of the material against established standards (ISO 6872:2008).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a non-AI/ML device.
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
Not applicable for a non-AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable for a non-AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is objective measurement against established international standards for ceramic dental materials (ISO 6872:2008) and internal specifications for density.
8. The sample size for the training set
Not applicable for a non-AI/ML device.
9. How the ground truth for the training set was established
Not applicable for a non-AI/ML device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shanghai New Century Dental Materials Co., Ltd. % Mr. Charles Shen Director Manton Business and Technology Services 37 Winding Ridge Oakland, New Jersey 07436
Re: K172761
Trade/Device Name: New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: September 13, 2017 Received: September 13, 2017
Dear Mr. 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.
November 17, 2017
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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 803); good manufacturing practice requirements as set forth in 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
for 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) K172761
Device Name
New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)
Indications for Use (Describe)
New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded) are Intended for use with CAD/CAM technology to produce all ceramic dental restorations (full contour crowns, bridges, inlays, and Veneers) as prescribed by a dentist.
| 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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K172761: 510(k) Summary:
Submitter & Foreign Manufacture Identification
| Name: | Shanghai New Century Dental Materials Co., Ltd. |
|---|---|
| Address: | No.461 Tanghang Village, Huating Town, Jiading DistrictShanghai, China. |
| Telephone: | (086) 21-59954240 |
Contact Person
Charles Shen Manton Business and Technology Services 37 Winding Ridge, Oakland, New Jersey 07436 Telephone: 608-217-9358 Email: cyshen@aol.com
Date of Summary: November 8, 2017
| Device Name: | |
|---|---|
| Proprietary Name: | New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) |
| Common Name: | Dental Zirconia Ceramics |
| Classification Name: | Powder, Porcelain |
| Device Classification: | II |
| Regulation Number: | 21 CFR 872.6660 |
| Panel: | Dental |
| Product Code: | EIH |
Predicate Device Information:
K140070 Luxer Shaded Zirconia
Device Description:
New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded) are derived from Zirconia powder that has been processed into their final net shapes. These blanks are then further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/ onlay. The zirconia powder is composed of ZrO2 + Y2O3 + HfO2 + A12O2. The performance of the dental blanks conforms to ISO 6872: 2008, Dentistry: Ceramic Materials
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The shading effects of New Century All-Ceramic Dental Zirconia Blocks (Pre-Shaded) are achieved by blending different zirconia powder material, all from the same supplier; have almost identical composition, differing only in the trace amount of inorganic pigments to achieve the shading effects in dental blanks. The performance of the preshaded dental zirconia blanks also conforms to ISO 6872, Dentistry: Ceramic Materials
Indications for Use:
New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) are intended for use with CAD/CAM technology to produce all ceramic dental restorations (full contour crowns, bridges, inlays, and Veneers) as prescribed by a dentist.
Summary of Non-Clinical Performance Testing:
Bench testing was performed per ISO 6872:2008 and using internal testing procedures (for presintered and sintered density) to ensure that the New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) met the specifications. All tests were verified to meet acceptance criteria. A biocompatibility assessment was conducted in accordance with ISO 10993-1.
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 (K140070) |
|---|---|---|
| Indication forUse | New Century All-Ceramic DentalZirconia Blocks (Un-Shaded & Pre-Shaded) are intended for use withCAD/CAM technology to produce allceramic dental restorations (full contourcrowns, bridges, inlays and Veneers) asprescribed by a dentist. | Luxer Shaded Zirconia blanks areIntended for use with CAD/CAMtechnology to produce all ceramic dentalrestorations (full contour crowns andbridges) as prescribed by a dentist. |
| Basic Design | Blocks, disc, and rod | Blocks |
| Materials | Yttria stabilized Zirconia from TOSOH TZSeries of zirconia (white, yellow, pink, andgray) | Yttria stabilized Zirconia from TOSOHTZ Series of zirconia (white, yellow,pink, and gray) |
| Processing | Sintering at temperature around 1500 °C | Public information not available |
| Dimension | Various | Various |
| Single Use | Yes | Yes |
Table 5.1: Comparison of Intended Use, Design, Material, and Processing
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| Color | None, and Pre-shaded ( for pre-shadedseries) | Pre-shaded |
|---|---|---|
| Sterile | Non-sterile | Non-sterile |
Our device is highly similar to the predicate device in terms of indications for use, design, material, and work flow to fabricate dental restorations. Our device is different from the predicate device in the following:
- The subject device has blocks, disc, and rod, while the predicate device only has (1) blocks. This difference does not raise any safety or efficacy concerns for two reasons: First, the initial product shape does not matter because they are going to be milled into the final shape before patient use. Secondly, the dental zirconia blanks are known to have multiple different shapes, including blocks, discs, and rods, such as described in K141724 by Liaoning Upcera Company Limited.
- (2) The sintering temperature is about 1500 ℃ for the subject device, while this information is not publicly available for the predicate device. This difference does not raise any safety or efficacy concerns as the sintering temperature mainly affects the physical and mechanical property of the dental blanks. Both the subject and predicate device have similar physical/mechanical properties that met the requirements of ISO 6872.
- (3) The subject has both non-shaded and pre-shaded blanks, while the predicate device has only the pre-shaded series. This difference does not raise any safety or efficacy concerns because there are many non-shaded zirconia blanks on the market, such as described in K141724 by Liaoning Upcera Company Limited.
Conclusion
In conclusion, based on the indications for use, technology and non-clinical performance testing, New Century All-Ceramic Dentistry Zirconia Blocks (Un-Shaded and Pre-Shaded) are substantially equivalent to K140070 Luxer Shaded Zirconia.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.