(28 days)
Not Found
No
The device description focuses on the materials and fabrication process of dental restorations using CAD/CAM technology, with no mention of AI or ML.
No.
The device is described as materials for fabricating dental restorations, not as a device used directly for therapy.
No
The device is described as materials (ceramic blanks and coloring liquids) used for fabricating all-ceramic dental restorations like crowns and bridges, not for diagnosing medical conditions.
No
The device description clearly states it consists of ceramic blanks and coloring liquids, which are physical materials, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) to examine specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The "ZENO Zr Disc" and associated products are used to fabricate dental restorations (crowns and bridges). They are materials and coloring agents used in a manufacturing process.
- Intended Use: The intended use is for "fabrication of all-ceramic single tooth and bridgework restorations." This is a manufacturing process for a medical device (the dental restoration), not a diagnostic test performed on a human specimen.
- No Specimen Analysis: The device description and intended use do not mention the analysis of any human specimens for diagnostic purposes.
Therefore, the "ZENO Zr Disc" and its components fall under the category of materials used to create a medical device (dental restorations), rather than being an In Vitro Diagnostic device itself.
N/A
Intended Use / Indications for Use
"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.
Product codes (comma separated list FDA assigned to the subject device)
EIH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior as well as in the posterior tooth region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional dental technicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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:
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.
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 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.
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: