"ZENO Zr Disc" is a group of medical devices, which is intended to fabricate allceramic dental restorations like crowns and bridges. It consists of ceramic blanks and colorina liquids.

"ZENOTEC Zr Bridge" and "ZENOSTAR Zr translucent" are yttria stabilized zirconium dioxide (Y-TZP) ceramic (zirconia) blanks for the CAD/CAM-production of dental restorations.

"ZENOTEC Color Zr" and "ZENOSTAR Color Zr" are coloring liquids for the shading of white zirconia ceramic materials.

The products are intended to be used by professional dental technicians for fabrication of all-ceramic single tooth and bridgework restorations, with one or two pontics, in the anterior as well as in the posterior tooth region.

Device Description

ZENO Zr Disc is a group of medical devices, which is intended to fabricate allceramic dental restorations like crowns and bridges. It consists of two various materials:

1.) "ZENOTEC Zr Bridge" and "ZENOSTAR Zr Translucent" are discoidal shaped and partially sintered dental ceramic materials that are composed of yttria (yttrium oxide) stabilized zirconium dioxide (Y-TZP). Both models are available in various colors, translucencies and thicknesses.

They are provided as pre-sintered blanks, which are ready to be processed in a milling machine with the CAD/CAM technology to get the desired shape, and has then to be sintered at high temperature to its full density, in order to achieve the wellknown, excellent effectiveness and safety of the zirconia.

Sintered ZENO Zr Disc materials are biocompatible, insoluble in water and have extremely high strengths. which makes it possible to manufacture delicate and filigree all-ceramic frameworks and restorations. This, together with the various available colors and translucencies of the zirconia materials, offers the basis for aesthetically pleasing, safe and effective dental restorations.

ZENO Zr Disc meets all applicable requirements of the standard ISO 6872: 2008 "Dentistry - Ceramic materials".

2.) "ZENOTEC Color Zr" and "ZENOSTAR Color Zr" are coloring liquids, which consist of watery, acidic metal salt solutions. They are intended to be used for the individual staining of dental zirconia frameworks and restorations.

They are provided in various shades. respectively. which are corresponding to every tooth color. For staining, the zirconia materials have to be immerged into the liguids (ZENOTEC Color Zr) or to be brushed with the liguids (ZENOSTAR Color Zr), before sintering at high temperatures.

Staining with ZENOTEC Color Zr or ZENOSTAR Color Zr does not have any impact on safety and efficiency of the zirconia, but only match the color of the material.

AI/ML Overview

The ZENO Zr Disc device is intended for fabricating all-ceramic dental restorations such as crowns and bridges, with the aid of CAD/CAM technology. The device consists of yttria-stabilized zirconium dioxide (Y-TZP) ceramic blanks (ZENO Zr Bridge and ZENOSTAR Zr Translucent) and coloring liquids (ZENOTEC Color Zr and ZENOSTAR Color Zr).

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from ISO 6872:2008 "Dentistry - Ceramic materials")	Reported Device Performance
Biocompatibility	Sintered ZENO Zr Disc materials are biocompatible.
Insoluble in water	Sintered ZENO Zr Disc materials are insoluble in water.
Extremely high strengths (for manufacturing delicate and filigree all-ceramic frameworks and restorations)	Sintered ZENO Zr Disc materials have extremely high strengths.
Ability to achieve full density after sintering at high temperature	The pre-sintered blanks are to be sintered at high temperature to its full density.
Effectiveness and Safety (comparable to predicate device)	"ZENO Zr Disc is as safe, as effective and performs as well than the predicate device."
Material constituents (comparable to predicate device)	"ZENO Zr Disc equals the predicate device with respect to ... the material constituents."
Application process (CAD/CAM-Technology) (comparable to predicate device)	"ZENO Zr Disc equals the predicate device with respect to ... the application process (CAD/CAM -Technology)."
Chemical solubility (comparable to predicate device)	"ZENO Zr Disc equals the predicate device with respect to ... the chemical solubility."
Other technical performances (comparable to predicate device)	"ZENO Zr Disc equals the predicate device with respect to ... the other technical performances."
No impact on safety and efficiency of zirconia from coloring liquids	"Staining with ZENOTEC Color Zr or ZENOSTAR Color Zr does not have any impact on safety and efficiency of the zirconia."

2. Sample size used for the test set and the data provenance:

The provided document does not specify a separate "test set" with a defined sample size in the context of a clinical study or performance verification using patient data. The claims of meeting acceptance criteria are based on bench testing against ISO standards and comparison to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the document does not describe a study involving expert-established ground truth for a test set. The validation relies on technical specifications and established standards for dental ceramic materials.

4. Adjudication method for the test set:

This information is not applicable as there is no described test set requiring adjudication in the context of human interpretation or classification.

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:

This is not applicable. The device is a dental material, not an AI-assisted diagnostic tool, so an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is a dental material, not an algorithm. Its performance is inherent in its material properties and manufacturing process, not through an algorithm.

7. The type of ground truth used:

The ground truth used for establishing the acceptance criteria of ZENO Zr Disc is based on:

International Standard ISO 6872: 2008 "Dentistry - Ceramic materials": This standard defines the performance requirements for dental ceramic materials, including properties like strength, biocompatibility, and solubility.
Predicate devices: The device's performance is also compared to legally marketed predicate devices (Cercon base (K013230) and LAVA Frame; LAVA Frame Shade; LAVA Ceram (K011394)) to establish substantial equivalence in terms of material constituents, application process, biocompatibility, chemical solubility, and other technical performances.

8. The sample size for the training set:

This information is not applicable. The document does not describe a "training set" as this device is not an AI/ML algorithm that requires training data.

9. How the ground truth for the training set was established:

This information is not applicable for the same reasons as #8.

Summary

{0}------------------------------------------------

KII 2710

OCT 1 7 2011

510(k) Summary 9

Wieland Dental + Technik GmbH & Co. KG Submitter of 510(k): 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: 09/16/2011

Proprietary name:

ZENO Zr Disc,

Model name:

ZENOTEC Zr Bridge ZENOSTAR Zr Translucent ZENOTEC Color Zr ZENOSTAR Color Zr

Product code: ElH C.D.R section: Classification:

Classification name: Porcelain powder for clinical use 872.6660 Class II

Legally marketed equivalent device:

Cercon base (K013230) LAVA Frame ; LAVA Frame Shade; LAVA Ceram (K011394)

{1}------------------------------------------------

510 (k) Summary

Device description

ZENO Zr Disc is a group of medical devices, which is intended to fabricate allceramic dental restorations like crowns and bridges. It consists of two various materials:

ZENO Zr Disc meets all applicable requirements of the standard ISO 6872: 2008 "Dentistry - Ceramic materials".

Staining with ZENOTEC Color Zr or ZENOSTAR Color Zr does not have any impact on safety and efficiency of the zirconia, but only match the color of the material.

Indications for use

ZENO Zr Disc is intended to be used by professional dental technicians for fabrication of all-ceramic restorations for the sole use of particular patients. It is recommended for manufacturing single-tooth and bridgework restorations, like crowns and bridges with one or two pontics, which can be used in the anterior as well as in the posterior tooth region.

Substantial equivalence

ZENO Zr Disc equals the predicate device with respect to the indications for use and the fundamental technology, i.e. the material constituents, the application process (CAD/CAM -Technology, the biocompatibility, the chemical solubility and the other technical performances.

For this reason, it can be concluded that ZENO Zr Disc is as safe, as effective and performs as well than the predicate device.

{2}------------------------------------------------

Composition of the ZENO Zr Disc assortment

1. ZENOTEC Zr Bridge

ZENOTEC Zr Bridge (white) ZENOTEC Zr Bridge (Colored) ZENOTEC Zr Bridge (Translucent)

The discs are provided in thicknesses of 10; 12; 14; 16; 18; 20 and 25 mm

2. ZENOSTAR Zr Translucent

ZENOSTAR Zr Translucent (pure) ZENOSTAR Zr Translucent (light) ZENOSTAR Zr Translucent (medium) ZENOSTAR Zr Translucent (intense)

The discs are provided in thicknesses of 10; 12; 14; 16; 18; 20 and 25 mm

3. ZENOTEC Color Zr

ZENOTEC Color Zr (A1 - A4; B1 - B4; C1 - C4; D2 - D4)

The coloring liquids are provided in 100 and 250 ml bottles.

4. ZENOSTAR Color Zr

ZENOSTAR Color Zr (A1 - A4; B1 - B4; C1 - C4; D2 - D4; brown, orange, greyviolett, white, ivory)

The coloring liquids are provided in 30ml bottles.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 1 7 2011

Dr. Gerhard Polzer Director Regulatory Affairs Wieland Dental + Technik GmbH & Co. KG Schwenninger Str. 13 D-75179 Pforzheim Germany

Re: K112710

Trade/Device Name: ZENO Zr Disc Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: September 16, 2011 Received: September 19, 2011

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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{4}------------------------------------------------

Page 2 - Dr. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

ph for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

K 11 27/0

Intended Use 4

"ZENO Zr Disc" is a group of medical devices, which is intended to fabricate allceramic dental restorations like crowns and bridges. It consists of ceramic blanks and colorina liquids.

"ZENOTEC Zr Bridge" and "ZENOSTAR Zr translucent" are yttria stabilized zirconium dioxide (Y-TZP) ceramic (zirconia) blanks for the CAD/CAM-production of dental restorations.

"ZENOTEC Color Zr" and "ZENOSTAR Color Zr" are coloring liquids for the shading of white zirconia ceramic materials.

The Indications for Use statement can be found in chapter 12.

C
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K112710 510(k) Number:

Regulation Number and Section

§ 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.