(61 days)
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.
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.
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.
This 510(k) submission for the Prismatik™ Clinical Zirconia (Prismatik™ CZ) porcelain powder does not include a specific study that outlines acceptance criteria and device performance in the same way a diagnostic AI device would. This device is a material used in the fabrication of dental restorations, not a diagnostic tool requiring performance metrics like sensitivity or specificity.
Instead, the submission relies on the concept of substantial equivalence to existing legally marketed predicate devices. This means that the manufacturer argues the new device is as safe and effective as similar devices already on the market without needing extensive clinical trials to prove efficacy.
Here's an breakdown based on the provided document, addressing the requested points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Similar Functionality to Predicate Devices | "The device functions in a similar manner to other comparative devices." |
| Same Intended Use as Predicate Devices | "the intended use is the same." |
| No New Safety Concerns Compared to Predicate Devices | "The differences between comparative devices are minor and do not raise new safety concerns." |
| Effectiveness and Suitability to Intended Purpose (Demonstrated by Predicates) | "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." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a material device, not a diagnostic device tested on a "test set" of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth as typically defined for AI/diagnostic devices (e.g., patient diagnoses) is not relevant for this material device. The "ground truth" here is the long-standing safe and effective use of similar dental materials.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not applicable to a dental material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The ground truth is based on the established safety and efficacy of predicate dental materials (Cercon® base, Lava™ Frame, and IPS e.max ZirCAD) through their "wide, general use." The FDA's substantial equivalence determination implies that if the existing devices are safe and effective, and this new device is similar enough, then it is also considered safe and effective.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
{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.
{1}------------------------------------------------
Kcl clot
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.
{3}------------------------------------------------
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
{4}------------------------------------------------
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
n androy, General Hoopil di : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : . Levest Leastes
- Kobolo4
§ 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.