(40 days)
PressX Zr is a pressable dental ceramic that can be used by dental technicians to fabricate all-ceramic restorations by pressing-over zirconium dioxide frameworks. The indications of these all-ceramic restorations are defined by the manufacturers of the zirconium dioxide (ZrO2) framework material, and normally encompass dental crowns and bridges. The coefficient of thermal expansion [CTE (25 - 500°C]] of these zirconium dioxide (ZrO2) frameworks has to equal approximately 10 x 10°K1. In addition, PressX Zr can be used to manufacture all-ceramic inlays, onlays, and veneers without zirconium dioxide frameworks.
PressX Zr is a dental press ceramic system that is intended to be used by professional dental technicians to manufacture all-ceramic dental prostheses for the sole use of particular patients. The PressX Zr system consists of solid glass ceramic (porcelain) pellets, which are intended to be pressed onto zirconium dioxide frameworks at high temperature, and of porcelain powders, which are intended to stain these all-ceramic restorations, individually. After overpressing, the restoration can be finished either by using the staining- or by using the layering-technique. For staining, the PressX Zr powders (Bodystains + Glaze) which are components of the PressX Zr system have to be applied. For lavering, the ZIROX -- powders (a product of Wieland Dental + Technik, K051249) have to be used. PressX Zr can be pressed onto any zirconium dioxide material, which has a coefficient of thermal expansion [CTE (25-500°C]] of about 10 x 10° K'.
The provided text is a 510(k) summary for a dental device called "PressX Zr". It outlines the device description, indications for use, and a comparison with a predicate device. However, it does not contain any information about acceptance criteria, clinical studies, sample sizes, expert involvement, ground truth establishment, or specific performance metrics.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or information about a study proving the device meets those criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device based on material properties (flexural strength, fracture resistance) and intended use, rather than presenting a clinical study with detailed performance metrics against specific acceptance criteria.
Based on the provided text, the following information is available (or explicitly not available):
- A table of acceptance criteria and the reported device performance:
- Not available. The document states: "Compared to the predicate device, PressX Zr has a higher flexural strength according to ISO 6872, and "standard crowns" made of PressX Zr have a significantly higher fracture resistance." However, it does not provide specific acceptance criterion values or the exact reported device performance values for these metrics. It only states they are "higher" or "significantly higher" than the predicate.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available. The document does not describe a clinical study or test set in this manner. The comparison is based on material properties and general performance claims rather than a detailed test set.
- 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):
- Not applicable / Not available. No such expert review or ground truth establishment for a test set is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not available. No test set or associated adjudication method is mentioned.
- 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:
- Not applicable. This device is a dental ceramic system, not an AI-assisted diagnostic tool or system that involves human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a dental ceramic system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not available. No ground truth for a clinical study is described. The comparison relies on material property standards (ISO 6872) and comparison to a predicate device.
- The sample size for the training set:
- Not applicable / Not available. The document describes a material and its manufacturing process, not a machine learning model that requires a training set.
- How the ground truth for the training set was established:
- Not applicable / Not available. As above, no training set or ground truth for it is relevant to this device description.
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Premarket Notification 510 (k) PressX Zr
Image /page/0/Picture/1 description: The image shows the word "WIELAND" in large, bold, black letters. Below "WIELAND" is the phrase "Dental + Technik" in a smaller font. The text is horizontally aligned and appears to be a logo or heading.
Wieland Dental + Technik GmbH & Co. KG Schwenninger Straße 13 D-75179 Pforzheim
Postfach 20 40 D-75120 Pforzheim Telefon 0 72 31/37 05-0 Telefax 0 72 31/35 79 59
510 (k) Summary
APR 3 0 2007
Device description
PressX Zr is a dental press ceramic system that is intended to be used by professional dental technicians to manufacture all-ceramic dental prostheses for the sole use of particular patients.
The PressX Zr system consists of solid glass ceramic (porcelain) pellets, which are intended to be pressed onto zirconium dioxide frameworks at high temperature, and of porcelain powders, which are intended to stain these all-ceramic restorations, individually.
After overpressing, the restoration can be finished either by using the staining- or by using the layering-technique. For staining, the PressX Zr powders (Bodystains + Glaze) which are components of the PressX Zr system have to be applied. For lavering, the ZIROX -- powders (a product of Wieland Dental + Technik, K051249) have to be used.
PressX Zr can be pressed onto any zirconium dioxide material, which has a coefficient of thermal expansion [CTE (25-500°C]] of about 10 x 10° K'.
Indications for use
The indications of the all -ceramic restorations, which are fabricated with zirconium dioxide frameworks and PressX Zr are mainly determined by the specifications of the zirconium dioxide framework materials and are fixed by their manufacturers. Usually, zirconium dioxide frameworks are intended for manufacturing dental crowns and bridges for the anterior and posterior region.
Additionally, PressX Zr can be used to manufacture all-ceramic inlays, onlays, and veneers without zirconium dioxide frameworks.
There is no limitation of the device regarding the patient population, in which commonly known contraindications for all-ceramic restorations, like bruxism, have to be considered by the dentists.
Comparison with the predicate device
PressX Zr equals the predicate device with regard to the intended use, material constituents, application process (overpressing technique), recommended framework material, biocompatibility and chemical solubility.
Compared to the predicate device, PressX Zr has a higher flexural strength according to ISO 6872, and "standard crowns" made of PressX Zr have a significantly higher fracture resistance.
For this reason, PressX Zr is at least as safe, as effective and performs as well or better than the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Dental + Technik GmbH & Co. KG Schwenninger Strasse 13 D-75179 Pforzheim GERMANY
APR 3 0 2007
Re: K070772
Trade/Device Name: PressX Zr Regulation Number: 21 CFR 872,6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: March 16, 2007 Received: March 21, 2007
Dear Dr. Polzer:
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 Novinatio Act (Act) that do not require approval of a premarket approval application (PMA). Tour 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 -- Dr. Gerhard Polzer
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); good manufacturing practice requirements as set forth in the quality systems (OS) 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu S. Lin, PhD
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): K070772
Device Name: PressX Zr
Indications for Use:
PressX Zr is a pressable dental ceramic that can be used by dental technicians to fabricate all-ceramic restorations by pressing-over zirconium dioxide frameworks. The indications of these all-ceramic restorations are defined by the manufacturers of the zirconium dioxide (ZrO2) framework material, and normally encompass dental crowns and bridges.
The coefficient of thermal expansion [CTE (25 - 500°C]] of these zirconium dioxide (ZrO2) frameworks has to equal approximately 10 x 10°K1
In addition, PressX Zr can be used to manufacture all-ceramic inlays, onlays, and veneers without zirconium dioxide frameworks.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Quapo
thesiology, General Hospit
Page 1 of 1
(Posted November 13, 2003)
§ 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.