COPRAN ZR/ORIGIN YZ

K092496 · White Peaks Dental Systems GmbH & Co. KG · EIH · Sep 18, 2009 · Dental

Device Facts

• Record ID: K092496
• Device Name: COPRAN ZR/ORIGIN YZ
• Applicant: White Peaks Dental Systems GmbH & Co. KG
• Product Code: EIH · Dental
• Decision Date: Sep 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended 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

Device Story

Copran Zr/ Origin YZ are presintered zirconia milling blanks; composed of biocompatible, tetragonal, polycrystalline zirconium dioxide. Used by dental technicians in dental laboratories; processed via CAD/CAM milling machines or manual milling to create dental restorations including crowns, bridges, inlays, onlays, and veneers. Blanks provided in various shapes (disks, cubes, bars, cylinders) to accommodate specific milling equipment. Final restorations are placed by dentists to restore tooth structure or function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Biocompatible, tetragonal, polycrystalline zirconium dioxide. Form factor: Presintered blanks (disks, cubes, bars, cylinders). Processing: CAD/CAM or manual milling. Energy source: N/A (mechanical milling).

Indications for Use

Indicated for dental patients requiring crown frameworks, bridge frameworks, primary conical/telescopic crowns, cantilevered bridges (max one pontic), inlays, onlays, or veneers in anterior and posterior areas.

Regulatory Classification

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.

Predicate Devices

• Zeno Zr (K073108)

Submission Summary (Full Text)

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K092496

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

[phone]

+ 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

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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)

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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.

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## 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 [phone] or [phone] 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

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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