(86 days)
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No
The device description focuses on the material composition and manufacturing process of zirconia blanks for dental restorations, with no mention of AI or ML technology. The CAD/CAM technology mentioned refers to the machining process, not necessarily an AI/ML-driven design or analysis system.
No.
The device is a material (zirconia blanks) used to fabricate dental prosthetics, which are restorative devices, not therapeutic.
No
Explanation: The device is a material (zirconia blanks) used to fabricate dental prosthetics, not to diagnose medical conditions. Its intended use is described as being "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."
No
The device description clearly states that the device is "X-cera Pre-shaded Zirconia Blanks," which are physical blanks made from zirconia powder. The description details the material composition, manufacturing process (molding, sintering), and physical forms (blocks, discs, rods). While the blanks are used with CAD/CAM technology, the device itself is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to produce dental restorations (artificial teeth, crowns, etc.) using CAD/CAM technology. This is a manufacturing process for a medical device that will be implanted or used in the mouth.
- Device Description: The description details the material composition and how the blanks are processed and fabricated into dental prosthetic devices. It focuses on the physical properties and manufacturing process of the material itself.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are specifically designed for these types of tests.
The device is a material used in the creation of a medical device (dental restoration), but it is not an IVD itself.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
EIH
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+ 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
dental laboratories or by dental professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Biocompatibility testing:
Cytotoxicity (ISO 10993-5:2009): No cytotoxicity effect
Irritation Oral Mucosa Irritation (ISO 10993-10: 2010): Not a primary oral mucosa irritant under the conditions of the study
Sensitization (ISO 10993-10: 2010): Not a sensitizer under the conditions of the study
Subacute and Subchronic Toxicity (ISO 10993-11: 2006): No subchronic toxic effects observed
Genotoxicity (ISO 10993-3: 2003): No genotoxic effects observed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 and Human Services logo. To the right of that 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.
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
1
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+
4
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 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 | Upcera Zirconia Blanks are indicated | |
| for dental restorations using different | ||
| CAD/CAM or manual milling | ||
| machines. All blanks are processed | ||
| through dental laboratories or by | ||
| dental 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
6
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 Mucosa | ||
| Irritation | ||
| (ISO 10993-10: 2010) | Not a primary oral mucosa | |
| irritant under the conditions of | ||
| the study | No intracutaneous reactivity | |
| Sensitization (ISO | ||
| 10993-10: 2010) | Not a sensitizer under the | |
| conditions of the study | Not a sensitizer under the | |
| conditions of the study | ||
| Subacute and | ||
| Subchronic Toxicity | ||
| (ISO 10993-11: 2006) | No subchronic toxic effects | |
| observed | No subchronic toxic effects | |
| observed | ||
| Genotoxicity (ISO | ||
| 10993-3: 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.