(67 days)
Zirox is a dental ceramic that can be used by dental technicians to fabricate all-ceramic restorations by veneering zirconium oxide (ZrO2) frameworks. The coefficient of thermal expansion [CTE (25-500°C) of these zirconium oxide (ZrO₂) frameworks has to equal approximately 10x10*9K1
Zirox® is a dental porcelain system that consists of 127 different ceramic powders. lt is intended to be used by professional dental technicians to manufacture all-ceramic dental appliances for the sole use of particular patients. Zirox® is recommended for veneering zirconium oxide (ZrQ), frameworks, in which it provides an easy to use dental restorative material to fabricate dental restorations with the best possible aesthetic results. The coefficient of thermal expansion [CTE ۾5-500°C] of these zirconium oxide (ZrO₂) frameworks had to be approximately 10 x 10 6 K1. Zirox® meets all applicable requirements of the standard ISO 6872: 1995 "Dental ceramic".
This document describes a premarket notification (510(k)) for a dental porcelain system called Zirox. The 510(k) process is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device, rather than proving efficacy through clinical trials with acceptance criteria based on performance metrics. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are common for AI/ML device evaluations, is not present in this type of regulatory submission for a dental material.
Here's a breakdown of what can be extracted from the provided text and why other requested information is not available:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the 510(k) summary. For a material like Zirox, "acceptance criteria" are usually based on meeting established national or international standards for dental materials (e.g., ISO standards), rather than performance metrics from a comparative clinical study. The device claims to meet ISO 6872:1995.
What is reported:
- Device meets relevant standard: "Zirox® meets all applicable requirements of the standard ISO 6872: 1995 "Dental ceramic"."
- Coefficient of Thermal Expansion (CTE) requirement: The zirconium oxide (ZrO₂) frameworks it veneers must have a CTE [25-500°C] of approximately 10 x 10⁻⁶ K⁻¹. (This is a requirement for the frameworks it interacts with, not an acceptance criterion for the device's own performance in a study).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is a 510(k) premarket notification for a dental material, not a study involving a test set of data. The submission relies on demonstrating substantial equivalence to a predicate device and adherence to material standards, not the analysis of a specific data set in the context of AI/ML evaluation.
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):
Not applicable. There is no test set or ground truth established by experts in the context of this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no test set or adjudication method described.
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:
Not applicable. This is a physical dental material, not an AI/ML device intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. There is no "ground truth" in the context of an AI/ML algorithm evaluation. The closest concept is the adherence to material standards (ISO 6872:1995).
8. The sample size for the training set:
Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable. There is no training set or ground truth in the context of an AI/ML algorithm evaluation.
Summary of Relevant Information from the 510(k) Notification for Zirox:
- Device Name: Zirox®
- Device Description: A dental porcelain system consisting of 127 different ceramic powders.
- Intended Use: To be used by professional dental technicians to manufacture all-ceramic dental appliances for individual patients, specifically for veneering zirconium oxide (ZrO₂) frameworks.
- Key Requirement/Performance Claim (for associated frameworks): The coefficient of thermal expansion [CTE 25-500°C] of the zirconium oxide (ZrO₂) frameworks to be veneered must be approximately 10 x 10⁻⁶ K⁻¹.
- Demonstration of Safety and Effectiveness: The device relies on demonstrating substantial equivalence to a legally marketed predicate device (Cerabien ZR Dental Porcelain System, K031968) and conformity to recognized standards.
- Conformance Standard: "Zirox® meets all applicable requirements of the standard ISO 6872: 1995 "Dental ceramic"."
Conclusion:
This 510(k) submission for Zirox is for a traditional dental material and therefore does not contain the types of acceptance criteria, study details, or ground truth methodologies that would be associated with an AI/ML device evaluation. The "study" in this context refers to the conformity assessment against an international standard (ISO 6872:1995) and the demonstration of substantial equivalence through material properties and intended use.
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JUL 2 2 2005
Premarket Notification 510 (k) Zirox
Image /page/0/Picture/2 description: The image shows the logo for WIELAND Dental + Technik. The word "WIELAND" is in large, bold, black letters. Below the word "WIELAND" is the phrase "Dental + Technik" in a smaller font.
Wieland Dental + Technik GmbH & Co. KG Schwenninger Straße 13 D-75179 Pforzheim
... . . . . . . . .
.. . . . . . . . . . . . .
Postfach 10 20 40 D-75120 Pforzheim Telefon 0 72 3173105 -0 Teletax 0 72 31735 79 59
5. 510 (k) Summary
Submitter of 510(k):
Wieland Dental + Technik GmbH & Co. KG Schwenninger Str. 13 D-75179 Pforzheim Germany Phone: +49-7231-3705-0
Contact person: Phone: Fax: e-mail:
Dr. Gerhard Polzer +49-7231-3705-219 +49-7231-357959 gerhard.polzer@wieland-dental.de
Date of Summary:
2005-04-27
Trade name:
Zirox®
Classification name: Product code: C.D.R section: Classification:
Porcelain powder for clinical use EIH 872.6660 Class II
Legally marketed equivalent device:
Cerabien ZR Dental Porcelain System
510(k) number:
K 031968
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Premarket Notification 510 (k) Zirox
Image /page/1/Picture/1 description: The image shows the word "WIELAND" in large, bold, black letters. Below "WIELAND" is the phrase "Dental + Technik" in a smaller, sans-serif font. The text is horizontally aligned and appears to be a logo or brand name.
Wieland Dental --Technik GmbH & Co. KG Schwenninger Straße 13 D - 15179 Plorzheim
Postlach 10 20 40 1)-75120 Ploczheim Telefon 0 72 31/ 37 05 · 0 Felefax 0 72 317 35 79 59
510 (k) Summary
Device description
Zirox® is a dental porcelain system that consists of 127 different ceramic powders.
lt is intended to be used by professional dental technicians to manufacture all-ceramic dental appliances for the sole use of particular patients.
Zirox® is recommended for veneering zirconium oxide (ZrQ), frameworks, in which it provides an easy to use dental restorative material to fabricate dental restorations with the best possible aesthetic results.
The coefficient of thermal expansion [CTE ۾5-500°C] of these zirconium oxide (ZrO₂) frameworks had to be approximately 10 x 10 6 K1
Zirox® meets all applicable requirements of the standard ISO 6872: 1995 "Dental ceramic".
| Type of Powder | Shades |
|---|---|
| Liner | A1; A2; A3; A3,5; A4; B1; B2; B3; B4; C1; C2; C3; C4; D2; D3; D4;White, Yellow, Violet, Orange, Brown, Gum |
| Dentine | A1; A2; A3; A3,5; A4; B1; B2; B3; B4; C1; C2; C3; C4; D2; D3; D4;Crystal 1 light; Crystal 2 pearl; Crystal 3 creme; Gum 1; Gum 2; Gum 3;Gum 4, Gum 5 |
| Chroma-Dentine Chromatix | A1; A2; A3; A3,5; A4; B1; B2; B3; B4; C1; C2; C3; C4; D2; D3; D4 |
| Dentine Modifier | Mocca; Corn; Mango; Caramel; Khaki; Brown; Yellow; Ivory; |
| Flu-Dentines | Flamingo; Straw; Bright; Sunny; Crystal; |
| Incisal / Enamel | Incisal 1, Incisal 2, Incisal 3; Incisal 4;Topas; Anthrazit; Amethist; Aquamarin; Citrin; Rubin; Lemon; Melon;Transpa Neutral; Transpa Clear |
| Opale incisal | Opale Incisal 1, Opale Incisal 2, Opale Incisal 3, Opale Incisal 4,Crystal Blue, Frosty, Milky, Snow, Ice |
| Shoulder porcelains margin | High Flu, High 1, High 2, High 3, High 4, High Red, High Crystal;Low Flu, Low 1, Low 2, Low 3, Low 4, Low 5, Low Bleach |
| Stain | White; Black; Grey; Caramel; Orange; Ocker; Peach; Melon; Blue; Steel;Violet; Gum; Marone; Olive; Ivory; Yellow;Bodystain A; Bodystain B; Bodystain C; Bodystain D |
| Glaze | Glaze |
| Correction | Correction |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Public Health Service
JUL 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gerhard Polzer Wieland Dental & Technik GMBH & Company KG Schwenninger Strabe 13 D-75179 Pforzheim GERMANY
Re: K051249
Trade/Device Name: ZIROX Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: May 4, 2005 Received: May 16, 2005
Dear Mr. 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 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 cither 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. 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 (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) 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" (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,
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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Indications for Use
510(k) Number (if known):
Zirox Device Name:
Indications For Use:
Zirox is a dental ceramic that can be used by dental technicians to fabricate all-ceramic restorations by veneering zirconium oxide (ZrO2) frameworks.
1051249
The coefficient of thermal expansion [CTE (25-500°C) of these zirconium oxide (ZrO₂) frameworks has to equal approximately 10x10*9K1
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Abber DDS for Dr. Susan Runner
(Division Sign-Off) Division of Anesthesiology. General Ho Infection Control, Dental Dev
510(k) Number: K051249
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§ 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.