NACERA Z AND NACERA Z MEDIUM

K080195 · Doceram Medical Ceramics GmbH · EIH · Apr 28, 2008 · Dental

Device Facts

• Record ID: K080195
• Device Name: NACERA Z AND NACERA Z MEDIUM
• Applicant: Doceram Medical Ceramics GmbH
• Product Code: EIH · Dental
• Decision Date: Apr 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Nacera Z and Nacera Z Medium are a dental ceramic designed to be used by dental technicians to manufacture all-ceramic restorations. Nacera Z and Nacera Z medium are Yttria (Yttrium Oxide) stabilized tetragonal zirconia (Zirconia oxide) powder delivered in a partially sintered state. Nacera Z and Nacera Z Medium is specially designed for use as framework (substructure) for dental restorations, single tooth or bridge type application at anterior and posterior locations. It is prepared for machining by use of CAM-techniques. The machined frameworks like dental crown and bridge works are sintered to full density.

Device Story

Nacera Z is a partially sintered yttrium oxide-stabilized zirconium oxide ceramic material; supplied as presintered blanks (disks, cylinders, cubes). Dental technicians use CAD/CAM milling centers to machine blanks into dental substructures (crowns/bridges). Machined frameworks undergo final sintering to achieve full density; veneered with dental porcelain using layering techniques. Device provides high-strength, biocompatible, biostable framework for anterior/posterior restorations. Benefits include precise, filigree framework design and aesthetic hues (white to light pearl). Used in dental laboratories.

Clinical Evidence

Bench testing only. Device meets ISO 6872:1999 (Dental ceramic) and ISO 13356:1997 (Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia) requirements for biocompatibility, biostability, and mechanical strength.

Technological Characteristics

Material: Yttria-stabilized tetragonal zirconia. Form: Presintered blanks (disks, cylinders, cubes). Density: 3.09 g/cm³ or 3.20 g/cm³. Processing: CAD/CAM milling followed by final sintering. Standards: ISO 6872:1999, ISO 13356:1997. Biocompatible and biostable.

Indications for Use

Indicated for dental technicians to manufacture all-ceramic dental restorations (single tooth or bridge frameworks) for anterior and posterior locations using CAD/CAM machining.

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

• Zerion beta (K061804)

Submission Summary (Full Text)

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Premarket Notification 510(k)

Nacera Z

Section VI

APR 2 8 2008

510 (K) Summary

| Submitter of 510 (k): | DOCERAM Medical Ceramics GmbH<br>Hesslingsweg 65-67<br>44309 Dortmund<br>Phone: [phone]<br>Telefax [phone]<br>e-mail [e-mail]<br>Web: www.doceram-medical.com |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Holger Wampers<br>General Manager<br>Phone: [phone]<br>Telefax [phone]<br>e-mail [e-mail] |
| Date of Summary | November 06, 2007 |
| Trade Name | Nacera Z<br>Nacera Z Medium |
| Classification name: | Porcelain Powder for clinical use |
| Product code | EIH |
| C.O.R. section | 872.6660 |
| Classification | Class II |
| Legally marketed equvalent device | Zerion beta |
| 510 (k) number | K061804 |
| Device Description | Nacera Z is a ceramic material for dental restorations.<br><br>Nacera Z is composed of partially sintered yttrium oxide stabi-<br>lized zirconium oxide.<br><br>Nacera Z is designed for manufacturing all-ceramic dental res-<br>torations (substructures) for the sole use of particular patients.<br>It is machined on milling centers by use of CAD/CAM tech-<br>niques for design and processing. |

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Nacera Z is designed for dental restorations like single tooth crowns or bridgeworks. It is biocompatible, biostable, and insoluble in water.

Due to the outstanding high strength of densely sintered ceramic restorations Nacera Z enables dental technicians to design finely shaped, precise, and filigree framework.

Nacera Z is delivered as presintered white blanks, which change during final sintering and effected by minimal alterations of oxide composition to characteristic hues from white to light pearl. That offers an outstanding basis for aesthetical restorations.

All above mentioned advantages ensure safe, resistant, and effective dental restorations.

Nacera Z substructures are well suited to be veneered with suitable dental porcelains using the layering technique.

Nacera Z meets all applicable requirements of International standard ISO 6872:1999 "Dental ceramic". It meets even the the international standard 13356:1997 "Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirkonia" for biocompatible and biostable dental implants and restorations.

The partially sintered Nacera Z blanks are fabricated in two different types, distincted by their presintered density and hue, each type available as disks with different dimensions depending upon custormer's request.

Nacera Z is delivered in various shapes and dimensions in order to meet individual customer requirements. Possible shapes are: disk, cylinder, cube.

Nacera Z is available in two different types. Nacera Z and Nacera Z Medium. The differ in hue effected by slightly changed ratios of the oxides in order to meet individual customer's requirements. Both types are available in both presintered densities 3,09 g/cm³ and 3,20 g/cm³

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 2 8 2008

Mr. Holger Wampers Managing Director DOCERAM Medical Ceramics GmbH Hesslingsweg 65-67 D-44309 Dortmund GERMANY

Re: K080195

Trade/Device Name: Nacera Z, Nacera Z Medium Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: January 2, 2008 Received: February 19, 2008

Dear Mr. Wampers:

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. Wampers

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination it as your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Fedurements. 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 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); \$1, CFR 1000, 1050 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sustite Y. Mchan Duid

Olivia Liao, 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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SECTION IV

## Indications for Use

17680195 510(k) Number (if known):

Device Name: Nacera Z, Nacera Z Medium

Indications for Use:

Nacera Z and Nacera Z Medium are a dental ceramic designed to be used by dental technicians to manufacture all-ceramic restorations. Nacera Z and Nacera Z medium are Yttria (Yttrium Oxide) stabilized tetragonal zirconia (Zirconia oxide) powder delivered in a partially sintered state.

Nacera Z and Nacera Z Medium is specially designed for use as framework (substructure) for dental restorations, single tooth or bridge type application at anterior and posterior locations.

It is prepared for machining by use of CAM-techniques.

The machined frameworks like dental crown and bridge works are sintered to full density.

Prescription Use Prescription Ose
(Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

> DRH_ Office of Device_Evaluation (ODE) Concurrence of C

Karin Malsky for MSK

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K080195

section IV