(35 days)
Not Found
No
The summary describes a material (zirconia blanks) used in CAD/CAM or manual milling for dental restorations. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The focus is on the material properties and intended uses in dental prosthetics.
No
The device is a pre-sintered blank for dental restorations and does not directly provide therapy. It is a material used to create therapeutic devices, but not one itself.
No
The product description clearly states it is for manufacturing dental restorations (e.g., crowns, bridges), which are prosthetic devices, not diagnostic ones.
No
The device description clearly states it is a physical product (zirconia blanks) used for milling dental restorations, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for creating dental restorations (crowns, bridges, inlays, onlays, veneers). These are physical devices implanted or placed in the mouth.
- Device Description: The description confirms that these are blanks for milling dental restorations.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used to create a product that will be used in vivo (inside the body).
N/A
Intended Use / Indications for Use
Copran Zr/ Origin YZ Zirconia blanks are presintered blanks for CAD CAM or manual milling, made from biocompatible, tetragonal and polycrystalline zirconiumdioxyde. Milling blanks designed for:
- Crown frameworks in the anterior and posterior areas
- Bridge frameworks in the anterior and posterior areas
- Primary conical crowns and telescopic crowns
- Cantilevered bridges with a max. of one pontic having a premolar width
- Inlays, Onlays, Veneers
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Copran Zr/ Origin YZ Zirconia blanks are presintered blanks for CAD CAM or manual milling, made from biocompatible, tetragonal and polycrystalline zirconiumdioxyde.
The devices are sold in different shapes, figures and dimensions to match the specification of the different CAD/CAM milling machines used to generate the final restaurations. This may be shapes like disks, cubes, bars and cylinders.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Premarket notification /510(k) Submission Copran Zr/ Origin YZ 5-510(k) Summary
SEP 1 8 2009
5
510(k) Summary
owner's name:
12
address: . . . phone:
fax numbers:
name of contact person:
date the summary was prepared:
Establishment Registration number:
name of the device:
trade or proprietary name: the classification name:
White Peaks Dental Systems GmbH& Co KG
Langheide 9
45239 Essen
Germany
+49 281 2064 5812
- 49 281 2064 5813
Mr. Oliver Puckert
2009-07-21
PENDING
Copran Zr/ Origin YZ
Remark:
.ﮈ
It is intended to market the identical device under two brand names: "Copran" and "Origin", whereas the majority of products sold to the USA will be "Origin".
Copran Zr/ Origin YZ
powder, porcelain
(21 CFR 872.6660 Product Code EIH)
Section 19/139 1.16 Date 2009-07-21
1
Premarket notification /510(k) Submission Copran Zr/ Origin YZ 5-510(k) Summary
Legally marketed device to which your firm is claiming equivalence
| Company: | Wieland |
|---|---|
| Device: | Zeno Zr |
| 510(k) No.: | K073108 |
Indications for Use
Copran Zr/ Origin YZ Zirconia blanks are presintered blanks for CAD CAM or manual milling, made from biocompatible, tetragonal and polycrystalline zirconiumdioxyde. Milling blanks designed for:
- Crown frameworks in the anterior and posterior areas ﮯ
- Bridge frameworks in the anterior and posterior areas
- Primary conical crowns and telescopic crowns
- Cantilevered bridges with a max. of one pontic having a premolar width ﺳﮯ
- Inlays, Onlays, Veneers
Shapes
The devices are sold in different shapes, figures and dimensions to match the specification of the different CAD/CAM milling machines used to generate the final restaurations.
This may be shapes like disks, cubes, bars and cylinders. (Examples see chapter 13, product labels)
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three wing-like shapes above a wavy line.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SEP 8 2009
White Peaks Dental Systems GmbH & Company KG C/O Mr. Stefan Preiss Responsible Third Party Official TUV SUD America, Incorporated 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891
Re: K092496
Trade/Device Name: Copran Zr/Origin YZ Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical use Regulatory Class: II Product Code: EIH Dated: September 11, 2009 Received: September 14, 2009
Dear Mr. Preiss:
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 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.
3
Page 2- Mr. Preiss
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 (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.
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/Reporta Problem/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,
hr for
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use 11-099996
Device Name: Copran Zr/ Origin YZ
510(k) Number (if known):
Copran Zr/ Origin YZ Zirconia blanks are presintered blanks for CAD CAM or manual milling, made from biocompatible, tetragonal and polycrystalline zirconiumdioxyde. Milling blanks designed for:
- Crown frameworks in the anterior and posterior areas -
- Bridge frameworks in the anterior and posterior areas →
- Primary conical crowns and telescopic crowns .
- Cantilevered bridges with a max. of one pontic having a premolar width -
- Inlays, Onlays, Veneers
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
Page 1 ot
Roen Marley
(Division Sign-Off) Division of Anesthesiology, General Hospital Integrion Control, Dental Devices
§10(k) Number: K092496
Section Page / of 18/135 Revision 1.16 2009-07-21 Date