(101 days)
ZERION is a dental ceramic designed for the fabrication of dental restorations by dental technicians. ZERION delivery state is a yttria (yttrium oxide) – stabilized tetragonal zirconia (zirconium oxide) powder, already partially sintered and made for machining by use of CAD/CAM-techniques. The machined frameworks (dental crown and bridge works) are then sintered to full density. ZERION is especially designed for use as framework (substructure) for dental restorations including single tooth or bridge type applications: on both anterior and posterior locations.
ZERION is a dental ceramic being composed of partially sintered yttrum oxide stabilized zirconium oxide. ZERION is designed for manufacturing of all-ceramic dental restorations like crown, bridgework, and related dental appliances to be machined on milling centers using CAD/CAM techniques for design and processing. ZERION is designed for use as dental restorations like single tooth crowns or bridgeworks with up to two pontics for the anterior and posterior teeth regions equally. The restorations made-up of ZERION are destinated for the sole use of particular patients. ZERION is biocompatible and insoluble in water. Due to the outstanding high strength of densely sintered ceramic Zerion restorations enable dental technicians to design finely shaped, precise, and filigree framework. The characteristic white color offers an outstanding basis for aesthetical restorations. All these advantares together ensure safe, resistant, and effective dental restorations. ZERION substructures are well suited to be veneered with suitable dental porcelains using the layering technique. ZERION meets all applicable requirements for biocompatible dental restorations of the international standard ISO 6872:1999 "Dental ceramic". It meets even the the international standard 1335:1997 "Implants for surgery – Ceramic materials based on Yttria-stabilized tetragonal zirkonia". The partially sintered ZERION blanks are fabricated in two different types distincted by their presintered density and each type available as disks with different dimensions as follows: ZERION alpha, ZERION beta.
The provided text describes the ZERION dental ceramic device and its premarket notification, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML or diagnostic performance.
Instead, the document focuses on regulatory approval based on demonstrating substantial equivalence to a legally marketed predicate device (XAWEX G 00, 510(k) number K050903) and meeting applicable international standards for dental ceramics.
Here's what can be extracted from the provided text, and what is explicitly missing based on your request:
Information Present in the Text:
- Device Description: ZERION is a dental ceramic composed of partially sintered yttrium oxide stabilized zirconium oxide, designed for manufacturing all-ceramic dental restorations (crowns, bridgework) using CAD/CAM techniques. It's intended for single-tooth crowns or bridgeworks with up to two pontics for anterior and posterior teeth.
- Biocompatibility and Standards Met: ZERION is biocompatible, insoluble in water, and meets applicable requirements for biocompatible dental restorations of ISO 6872:1999 "Dental ceramic" and ISO 1335:1997 "Implants for surgery – Ceramic materials based on Yttria-stabilized tetragonal zirconia". These standards likely contain performance specifications relevant to material properties, but specific acceptance criteria for diagnostic performance (as implied by your request related to AI/ML and human readers) are not detailed.
- Regulatory Classification: Class II, Product Code EIH, Regulation Number 872.6660 (Porcelain Powder for clinical use).
- Indications for Use: Fabrication of dental restorations (framework/substructure) for single tooth or bridge type applications on both anterior and posterior locations by dental technicians, using CAD/CAM techniques.
Information NOT Present in the Text (and therefore cannot be provided for your specific questions):
- A table of acceptance criteria and the reported device performance (in the context of diagnostic/AI performance). The document mentions meeting ISO standards but doesn't list specific performance metrics like sensitivity, specificity, or image quality assessments related to AI.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance.
- If a standalone (algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
Conclusion:
The provided document describes a dental material (ceramic for restorations), not a diagnostic device involving AI/ML or human interpretation of medical images. Therefore, the questions related to diagnostic performance, ground truth, expert adjudication, and AI assistance do not apply to the content of this 510(k) summary. The "acceptance criteria" mentioned are likely related to material properties (strength, biocompatibility, dimensions) as per the ISO standards cited, rather than diagnostic accuracy.
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Premarket Notification 510(k) ZERION
Ko6/804
Section VI
、
OCT -6 2006
510 (K) Summary
| Submitter of 510 (k): | etkon international gmbhLochhamer Schlag 681266 Graefelfing |
|---|---|
| Phone: | +49-89-89827255 |
| Telefax | +49-89-89827247 |
| info@etkon.de | |
| Web: | http://www.etkon.de |
| Contact person | Kirsti HavensleinRegulatory affairs representative |
| Phone: | +49-89-89827254 |
| Telefax | +49-89-89827250 |
| kirsti.havenstein@etkon.de | |
| Date of Summary | June 14, 2006 |
| Trade Name | ZERION |
| Classification name: | Porcelain Powder for clinical use |
| Product code | EIH |
| C.O.R. section | 872.6660 |
| Classification | Class II |
| Legally marketed equivalent device | XAWEX G 00 |
| 510 (k) number | K050903 |
| Device Description | ZERION is a dental ceramic being composed of partiallysintered yttrum oxide stabilized zirconium oxide.ZERION is designed for manufacturing of all-ceramic dentalrestorations like crown, bridgework, and related dental appli-ances to be machined on milling centers using CAD/CAM tech-niques for design and processing.ZERION is designed for use as dental restorations like sin-gle tooth crowns or bridgeworks with up to two pontics for theanterior and posterior teeth regions equally. The restorationsmade-up of ZERION are destinated for the sole use of par-ticular patients. |
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Premarket Notification 510(k) ZERION
Z E R I O N is biocompatible and insoluble in water. Due to the outstanding high strength of densely sintered ceramic Zerionrestorations enable dental technicians to design finely shaped, precise, and fili;ree framework. The characteristic white color offers an outstanding basis for aesthetical restorations. All these advantares together ensure safe, resistant, and effective dental restorations.
Z E R I O N substructures are well suited to be veneered with suitable dental porcelains using the layering technique.
ZERION meets all applicable requirements for biocompatible dental restorations of the uinternational standard ISO 6872:1999 "Dental ceramic". It meets even the the international standard 1335:1997 "Implants for surgery – Ceramic materials based on Yttria-stabilized tetragonal zirkonia".
The partially sintered ZERION blanks are fabricated in two different types distincted by their presintered density and each type available as disks with different dimensions as follows:
| type of product | diskdiameter[mm] | heigth of disks [mm] | |||||
|---|---|---|---|---|---|---|---|
| ZERION alpha | 98 | 10 | 12 | 14 | 18 | 20 | 25 |
| ZERION beta | 98 | 10 | 12 | 14 | 18 | 20 | 25 |
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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 circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract symbol of a stylized human figure with three heads.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 6 - 2006
Mr. Matthias Zitzmann Managing Director ETKON International. GmbH Lochhamer Schlag 6 Grafelfing, Bavaria, GERMANY 82166
Re: K061804
Trade/Device Name: Zerion Alpha, Zerion Beta Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: September 19, 2006 Received: September 21, 2006
Dear Mr. Zitzmann:
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. Zitzmann
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 squares. 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 progetice 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.
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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Premarket Notification 510(k) ZERION
SECTION IV
INDICATIONS FOR USE
ZERION is a dental ceramic designed for the fabrication of dental restorations by dental technicians.
ZERION delivery state is a yttria (yttrium oxide) – stabilized tetragonal zirconia (zirconium oxide) powder, already partially sintered and made for machining by use of CAD/CAM-techniques. The machined frameworks (dental crown and bridge works) are then sintered to full density.
ZERION is especially designed for use as framework (substructure) for dental restorations including single tooth or bridge type applications: on both anterior and posterior locations.
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on Sign-Off)
ision of Anesthesiology, General Hospital,
Icon Control, Dental Devices
c) Number: K064)804
§ 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.