(61 days)
Not Found
No
The summary describes a dental material (zirconium oxide powder) used in a traditional fabrication process. There is no mention of software, algorithms, or any technology that would suggest AI/ML is involved.
No.
The device is a material (zirconium oxide powder blanks) used by dental technicians to construct custom all-ceramic restorations and prostheses, not to treat a condition or disease directly in a patient.
No
The device is described as dental porcelain zirconium oxide powder used in the fabrication of dental restorations (prostheses), not for diagnosing conditions.
No
The device description explicitly states it is comprised primarily of dental porcelain zirconium oxide powder, indicating it 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 for the construction of custom-made dental restorations (prostheses) for anterior and posterior locations. This is a manufacturing process for a medical device that will be placed in the body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The device is a material (zirconium oxide powder blanks) used in a dental laboratory process to fabricate a physical restoration. It's a component of a medical device, not a diagnostic tool.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or provide information about a patient's health status or disease.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely related to the fabrication of a dental prosthesis.
N/A
Intended Use / Indications for Use
The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior locations.
For use in prosthetic dentistry to create porcelain (ceramic) prostheses.
Product codes
EIH
Device Description
The device is comprised primarily of of dental porcelain zirconium oxide powder that is used in the form of blanks as a part of dental laboratory processes that are used to fabricate all ceramic dental restorations, reinforced with a hard ceramic core, that are custom fitted to conform precisely to patients' models.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior locations (referring to dental restorations)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental technicians, dental professional such as a DDS or DMD
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Cercon® base (Dentsply), Lava™ Frame (3M), and IPS e.max ZirCAD (Ivoclar-Vivadent)
Reference Device(s)
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
MAR 15 2006
510(k) Summary
Submitter: Glidewell Laboratories 4141 MacArthur Blvd. Newport Beach, CA 92660
Contact Person Keith D. Allred 949-440-2683 949-440-2787 (fax)
Date of Application: January 11, 2005
Device Name:
- Trade Name Prismatik™ Clinical Zirconia (Prismatik™ CZ)
- · Common Name Porcelain powder for clinical use
- · Classification II
- Product Code EIH
Description: The device is comprised primarily of of dental porcelain zirconium oxide powder that is used in the form of blanks as a part of dental laboratory processes that are used to fabricate all ceramic dental restorations, reinforced with a hard ceramic core, that are custom fitted to conform precisely to patients' models.
Intended Use: The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior locations.
Substantial Equivalence: The device is substantially equivalent to other legally marketed devices in the United States. Substantially equivalent devices include the following: Cercon® base (Dentsply), Lava™ Frame (3M), and IPS e.max ZirCAD (Ivoclar-Vivadent).
Safety and Efficacy: The device functions in a similar manner to other comparative devices and the intended use is the same. The differences between comparative devices are minor and do not raise new safety concerns. The effectiveness and suitability to the intended purpose of the device is assured through wide, general use of similar other predicate devices, and demonstrates the safe use of the device to construct dental restorations.
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Schedule B
Sample Device Label/Indications for Use Statement
- 510(k) Number (if known): ♪
- Device Name: Prismatik™ Clinical Zirconia (Prismatik™ CZ) ア
- Indications for Use: ア
For use in prosthetic dentistry to create porcelain (ceramic) prostheses.
For use only by or on the order of a dental professional such as a DDS or DMD. Not for use by the general public or OTC.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the seal is a stylized caduceus, which is a symbol of medicine. The caduceus is made up of three lines that form a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2006
Mr. Keith D. Allred Glidewell Laboratories 4141 MacArthur Blvd. Newport Beach, California 92660
Re: K060104
Trade/Device Name: Prismatik™ Clinical Zirconia (Prismatik™ CZ) Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: January 11, 2006 Received: January 20, 2006
Dear Mr. Allred:
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 such 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. Keith D. Allred
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oe actived that I Drivination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any 1 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) remarket notification. The FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ours
Chiu Lin, Ph.D. 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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Schedule B
Sample Device Label/Indications for Use Statement
- 510(k) Number (if known): ♪
- Device Name: Prismatik™ Clinical Zirconia (Prismatik™ (Z) ♪
- Indications for Use: ♪
For use in prosthetic dentistry to create porcelain (ceramic) prostheses.
For use only by or on the order of a dental professional such as a DDS or DMD. Not for use by the general public or OTC.
Susan Runor
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