(71 days)
Upcera Zirconia Blanks are intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Upcera Zirconia Blanks are derived from zirconia powder that has been processed 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 provided text is a 510(k) summary for the Upcera Zirconia Blanks. This document is for a dental material, not an AI/ML powered device, therefore, the requested information points regarding AI/ML device performance and study details (such as sample size for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this submission.
The acceptance criteria and device performance for this type of device are primarily related to material properties and substantial equivalence to a predicate device, rather than diagnostic accuracy metrics.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (a dental material), "acceptance criteria" and "device performance" are typically demonstrated through:
- Substantial Equivalence: Showing the new device has the same intended use and technological characteristics as a legally marketed predicate device, or has different technological characteristics but is as safe and effective and does not raise new questions of safety or effectiveness.
- Material Properties: Mechanical, chemical, and biological properties of the material are assessed to ensure it meets established standards for dental materials. While specific values are not provided in this summary, the FDA's clearance implies these were provided in the full submission.
| Acceptance Criteria (Implied for Dental Materials) | Reported Device Performance (Implied from 510(k) Clearance) |
|---|---|
| Intended Use: Same as predicate device (Porcelain Powder for Clinical Use). | Met: "Upcera Zirconia Blanks are intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers." This matches the general intended use of the predicated device and other devices in the same classification. |
| Technological Characteristics: Similar to predicate (Zirconia Blanks, Type BYZ), or differences do not raise new safety/effectiveness questions. | Met: The summary states, "It has been shown in this 510(k) submission that the differences between the Upcera Zirconia Blanks and the predicate device do not raise any questions regarding its safety and effectiveness. Upcera Zirconia Blanks, as designed and manufactured, are as safe and effective as the predicate device and therefore is determined to be substantially equivalent to the referenced predicate device." This implies that the material composition, processing, and resulting properties are comparable to the predicate or have been demonstrated not to introduce new risks. Specific performance values for properties like flexural strength, biocompatibility, etc., would have been submitted to the FDA but are not detailed in this public summary. |
| Safety and Effectiveness: Demonstrate device is as safe and effective as the predicate device. | Met: The FDA has cleared the device, stating it is "substantially equivalent" to the predicate, which inherently confirms its safety and effectiveness for its intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to a 510(k) submission for a dental material like Zirconia Blanks, as it does not involve a "test set" in the context of an AI/ML algorithm or diagnostic study. The approval is based on material characterization and comparison to a predicate device.
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 to this 510(k) submission. "Ground truth" in this context would relate to material standards and potentially biocompatibility testing, not expert interpretation of diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to this 510(k) submission.
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 is not applicable to this 510(k) submission. This is a material, not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable to this 510(k) submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a dental material, the "ground truth" for its properties is established through adherence to recognized international and national standards for material testing (e.g., ISO standards for dental ceramics, biocompatibility standards). The raw data would come from laboratory tests of mechanical properties, chemical composition, microstructure, and biocompatibility assays.
8. The sample size for the training set
This is not applicable to this 510(k) submission.
9. How the ground truth for the training set was established
This is not applicable to this 510(k) submission.
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SECTION 5 - 510(k) SUMMARY
Submission Correspondent
Emergo Group, Inc.
Address
1705 S. Capital of Texas Hwy Suite 500 Austin, TX 78746
Phone
(512) 327-9997
Fax
(512) 327-9998
Contact
Stuart R. Goldman
Submission Sponsor
Shenyang Upcera Co., Ltd. 18-9B Yaoyang Road Huishan Economic Development Zone Shenbei New District Shenyang, Liaoning, P.R.C. Postal Code:110164 Tel : +86 24 88086882 Fax : +86 24 880868
www.upcera-dental.com
Date Prepared
August 14, 2009
JAN 2 8 2010
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Trade Name
Upcera Zirconia Blanks
Regulation Name
Porcelain Powder for Clinical Use
Regulation Number
872.6660
Classification Name
Powder, Porcelain
Product Code(s)
EIH
Classification Panel
Dental Devices
Regulatory Class
Class II
Device Description
Upcera Zirconia Blanks are derived from zirconia powder that has been processed 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.
Intended Use
Upcera Zirconia Blanks are intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
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Predicate Device
K081850 - Bisque Zirconia Blanks, Type BYZ
Safety and Effectiveness
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is as safe and effective as the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
It has been shown in this 510(k) submission that the differences between the Upcera Zirconia Blanks and the predicate device do not raise any questions regarding its safety and effectiveness. Upcera Zirconia Blanks, as designed and manufactured, are as safe and effective as the predicate device and therefore is determined to be substantially equivalent to the referenced predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Shenyang Upcera Company, Limited C/O Mr. Stuart R. Goldman Senior Consultant Emergo Group, Incorporated 1705 South Capital of Texas Highway, Suite 500 Austin, Texas 78746
JAN 2 8 2010
Re: K093560
Trade/Device Name: Upcera Zirconia Blanks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: November 10, 2009 Received: November 21, 2009
Dear Mr Goldman:
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.
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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Page 2 - Mr. Goldman
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Th
f.c.
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, 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): K093560
Device Name:
Upcera Zirconia Blanks
Indications for Use:
Upcera Zirconia Blanks are intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and vinneers.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
TELEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Muhy for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
1
§ 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.