(86 days)
X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/CAM technology to produce all ceramic dental restorations as prescribed by a dentist. All blanks are processed through dental laboratories or by dental professionals
"X-cera Pre-shaded Zirconia Blanks" is derived from zirconia powder that has been processed through various molding and sintering techniques - into their final net shapes. These blanks are then further fabricated into various prosthetic dental devices intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. The zirconia powder is composed of ZrO2+ Y2O3 + HfO2+ Fe2O3+ Er2O3+ Al2O3. The performance of formed zirconia dental blanks conforms to ISO 6872, Dentistry, Ceramic Materials.
"X-cera Pre-shaded Zirconia Blanks" is ceramic dental blanks designed for the manufacture of ceramic 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. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO2 so that its final properties can be achieved.
"X-cera Pre-shaded Zirconia Blanks" is supplied in different shapes, such as blocks, discs, rods, or customer ordered shapes. It is also supplied in the combinations of forty nine different colors. The different colors are originated from the different constituent of color additives (such as Fe2O3, Er2O3).
The provided text describes a 510(k) premarket notification for "X-cera Pre-shaded Zirconia Blanks," a dental device. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing (physical and chemical properties) and biocompatibility testing. It does not describe an AI/ML-driven medical device, nor does it involve a study with human readers, ground truth derived from expert consensus/pathology, or the typical metrics (sensitivity, specificity, AUC) associated with such devices.
Therefore, many of the requested details for an AI/ML device (e.g., sample size for training/test sets, expert qualifications, HRMC studies, standalone performance with AI, effect size of human improvement with AI) are not applicable to this submission.
Here's a breakdown of the information that is applicable, based on the provided text, and an explanation of why other points are not.
Acceptance Criteria and Device Performance (based on provided text):
The acceptance criteria are generally "met specifications" and "met all relevant requirements in the test standard" (ISO 6872 for performance, ISO 10993 for biocompatibility). The performance is presented as a comparison to the predicate device, not in terms of specific numerical thresholds for each test, but rather that the results were "very similar" or "comparable."
| Criterion Type | Acceptance Criteria (General) | Reported Device Performance |
|---|---|---|
| Physical/Chemical Performance | Meets specifications per ISO 6872:2015 for dental ceramic materials | "All tests were verified to meet acceptance criteria." / "Test results on radioactivity, pre-sintered density, sintered density, and flexural strength of the subject device are very similar to the predicate device." |
| Biocompatibility | Meets requirements per ISO 10993 (various parts) | Cytotoxicity: No cytotoxicity effect (met acceptance criteria). Irritation Oral Mucosa: Not a primary oral mucosa irritant (met acceptance criteria). Sensitization: Not a sensitizer (met acceptance criteria). Subacute/Subchronic Toxicity: No subchronic toxic effects observed (met acceptance criteria). Genotoxicity: No genotoxic effects observed (met acceptance criteria). |
Information NOT Applicable/Available for this Device Type (AI/ML Context):
Most of the questions relate to studies for AI/ML devices, which are not relevant here. The "device" in this context is a physical material (zirconia blanks) used for dental restorations, not a software algorithm.
Here's why and what's explicitly not available or applicable:
- Sample sizes used for the test set and the data provenance: This refers to the number of cases or patients in a clinical image dataset for AI evaluation. For a physical material, "test set" would refer to the number of material samples tested. The document states "Bench testing was performed per ISO 6872:2015 and internal procedures." It does not specify the number of individual blanks or samples tested for each property (e.g., flexural strength). There is no "data provenance" in the sense of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is entirely irrelevant. "Ground truth" for this device's performance is established by physical and chemical laboratory tests (e.g., measuring flexural strength, chemical composition, performing biocompatibility assays), not human expert interpretation of medical images.
- Adjudication method for the test set: Not applicable. There is no human interpretation or "adjudication" of findings.
- 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. This device does not involve human readers interacting with AI.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on standardized laboratory measurements and chemical analysis as defined by ISO standards (ISO 6872 for performance, ISO 10993 for biocompatibility).
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary regarding the provided document's context:
The FDA 510(k) clearance process for a physical dental material like zirconia blanks focuses on demonstrating safety and effectiveness by showing that the material performs as intended (e.g., strength, durability) and is biocompatible, and that it is substantially equivalent to a legally marketed predicate device. This is done through well-established bench testing (physical property measurements) and biocompatibility studies, not through clinical studies involving patient data, expert readers, or AI performance metrics.
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December 10, 2020
Dongguan Xiangtong Co., Ltd. % Charles Shen Director Manton Business and Technology Services 37 Winding Ridge Oakland, New Jersey 07436
Re: K202673
Trade/Device Name: X-cera Pre-shaded Zirconia Blanks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: September 15, 2020 Received: September 15, 2020
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. 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 located 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.
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
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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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 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,
For Srinivas Nandkumar, Ph. D. Director DHT1B: Division of Dental 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
510(k) Number (if known) K202673
Device Name X-cera Pre-shaded Zirconia Blanks
Indications for Use (Describe)
X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/CAM technology to produce all ceramic dental restorations as prescribed by a dentist. All blanks are processed through dental laboratories or by dental professionals
| 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: K202673
This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92
Submitter & Foreign Manufacture Identification 5.1
DONGGUAN XIANGTONG CO., LTD NO.4, Tech 9th Rd, Hi-Tech Industrial Development Zone, Songshan Lake, Dongguan,Guangdong, China., Zipcode 523808 Tel: (086)-0755-22895688 Submitter's FDA Registration Number: N/A
Contact Person 5.2
Charles Shen Manton Business and Technology Services 37 Winding Ridge, Oakland, NJ 07436 Tel: 608-217-9358 Email: cyshen@aol.com
Date of Summary: August 29, 2020 5.3
| 5.4 Device Name: | |
|---|---|
| Proprietary Name: | X-cera Pre-shaded Zirconia Blanks |
| Common Name: | Dental Zirconia Ceramics |
| Classification Name: | Powder, Porcelain |
| Device Classification: | II |
| Regulation Number: | 21 CFR 872.6660 |
| Panel: General | Dental |
| Product Code: | EIH |
ર્સ્ટ Primary Predicate Information:
- K093560, "Upcera Zirconia Blanks", manufactured by "Shenyang Upcera Co., (1) Ltd."
ર્સ્વ Device Description:
"X-cera Pre-shaded Zirconia Blanks" is derived from zirconia powder that has been processed through various molding and sintering techniques - into their final net shapes. These blanks are then further fabricated into various prosthetic dental devices intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. The zirconia powder is composed of ZrO2+ Y2O3 + HfO2+
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Fe2O3+ Er2O3+ Al2O3. The performance of formed zirconia dental blanks conforms to ISO 6872, Dentistry, Ceramic Materials.
"X-cera Pre-shaded Zirconia Blanks" is ceramic dental blanks designed for the manufacture of ceramic 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. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO2 so that its final properties can be achieved.
"X-cera Pre-shaded Zirconia Blanks" is supplied in different shapes, such as blocks, discs, rods, or customer ordered shapes. It is also supplied in the combinations of forty nine different colors. The different colors are originated from the different constituent of color additives (such as Fe2O3, Er2O3).
5.7 Indications for Use:
X-cera Pre-shaded Zirconia Blanks are intended for use with CAD/CAM technology to produce all ceramic dental restorations as prescribed by a dentist. All blanks are processed through dental laboratories or by dental professionals
5.8 Summary of Device Testing:
Bench testing was performed per ISO 6872:2015 and internal procedures to ensure that the "X-cera Pre-shaded Zirconia Blanks" 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.
રું છે Technological Comparison with Predicate Device
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
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| Description | Subject Device | Predicate Device (K093560) |
|---|---|---|
| Indication forUse | X-cera Pre-shaded Zirconia Blanks areIntended for use with CAD/CAMtechnology to produce all ceramic dentalrestorations as prescribed by a dentist.All blanks are processed through dentallaboratories or by dental professionals | Upcera Zirconia Blanks are indicatedfor dental restorations using differentCAD/CAM or manual millingmachines. All blanks are processedthrough dental laboratories or bydental professionals. |
| Basic Design | Blocks, disc, and rod | Blocks, disc, and rod |
| Materials | Zirconia $(ZrO2 + Y2O3 + HfO2 + Al2O3) \ge 98%$Inorganic pigments | Zirconia $(ZrO2 + Y2O3 + HfO2 + Al2O3 \ge 99.0%)$ |
| Processing | Sintering at temperature > 1400 °C | Sintering at temperature > 1500 °C |
| Dimension | Various | Various |
| Single Use | Yes | Yes |
| Color | Forty nine colors | None |
| 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 only minor difference is that the predicate device has no color, while our devices in submission have pre-shaded series of forty nine different colors.
The different colors are originated from the different constituent of color additive (such as Fe2O3, Er2O3).
These differences do not raise any concerns, demonstrated by biocompatibility study.
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 6872, and results met all relevant requirements in the test standard. Test results on radioactivity, pre-sintered density, sintered density, and flexural strength of the subject device are very similar to the predicate device.
The following table shows similarities and differences of the biocompatibility between our device and the predicate devices. Tests were conducted following the recommended procedures outlined in the FDA recognized consensus standard of ISO 10993, and results
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met all relevant requirements in the test standards, and are comparable to the predicate device.
| Description | Subject Device | Predicate Device (K093560) |
|---|---|---|
| Cytotoxicity(ISO 10993-5:2009) | No cytotoxicity effect | No cytotoxicity effect |
| Irritation Oral MucosaIrritation(ISO 10993-10: 2010) | Not a primary oral mucosairritant under the conditions ofthe study | No intracutaneous reactivity |
| Sensitization (ISO10993-10: 2010) | Not a sensitizer under theconditions of the study | Not a sensitizer under theconditions of the study |
| Subacute andSubchronic Toxicity(ISO 10993-11: 2006) | No subchronic toxic effectsobserved | No subchronic toxic effectsobserved |
| Genotoxicity (ISO10993-3: 2003) | No genotoxic effects observed | N/A |
Table 5.2: Comparison of Biocompatibility Testing
Therefore, "X-cera Pre-shaded Zirconia Blanks" manufactured by "DONGGUAN XIANGTONG CO., LTD." meet requirements per ISO 6872 and ISO 10993-1. It is safe and effective, and its performance meets the requirements of its pre-defined acceptance criteria and intended uses. The test results are also comparable to the predicate device.
5.11 Substantial Equivalence Conclusion
It has been shown in this 510(k) submission that "X-cera Pre-shaded Zirconia Blanks" and its predicate devices have the identical indications for use, similar composition and biocompatibility, similar manufacturing process, and similar performance.
The difference between the "X-cera Pre-shaded Zirconia Blanks" and their predicate device do not raise any question regarding its equivalence.
"X-cera Pre-shaded Zirconia Blanks", as designed and manufactured, is equivalent to its predicate device, and therefore is substantially equivalent as its predicate device.
§ 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.