(71 days)
Not Found
No
The summary describes a material (zirconia blanks) used in dental prosthetics and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a blank used to produce artificial teeth; it does not directly prevent, diagnose, or treat a disease or condition.
No
Explanation: The device is described as Upcera Zirconia Blanks, which are used in the production of artificial teeth. Its intended use is for fabricating prosthetic dental devices such as fixed or removable dentures, jacket crowns, facings, and veneers. These are restorative or prosthetic devices, not diagnostic ones.
No
The device description clearly states that the device is derived from zirconia powder and processed into physical blanks, indicating it is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the production of artificial teeth and dental prosthetics. This is a manufacturing process for a medical device, not a diagnostic test performed on biological samples.
- Device Description: The description details the material and its use in fabricating dental devices. It does not mention any interaction with biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The document lacks any mention of typical IVD elements such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the Upcera Zirconia Blanks are a material used in the manufacturing of dental prosthetics, which are medical devices, but not IVDs.
N/A
Intended Use / 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 veneers.
Product codes (comma separated list FDA assigned to the subject device)
EIH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K081850 - Bisque Zirconia Blanks, Type BYZ
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
1
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.
2
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.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
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
5
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