ZIROX

K051249 · Wieland Dental + Technik GmbH & Co. KG · EIH · Jul 22, 2005 · Dental

Device Facts

• Record ID: K051249
• Device Name: ZIROX
• Applicant: Wieland Dental + Technik GmbH & Co. KG
• Product Code: EIH · Dental
• Decision Date: Jul 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Zirox is a dental ceramic that can be used by dental technicians to fabricate all-ceramic restorations by veneering zirconium oxide (ZrO2) frameworks. The coefficient of thermal expansion [CTE (25-500°C) of these zirconium oxide (ZrO₂) frameworks has to equal approximately 10x10*9K1

Device Story

Zirox is a dental porcelain system comprising 127 ceramic powders; used by professional dental technicians in laboratory settings to fabricate all-ceramic dental appliances. Device functions as a veneering material for zirconium oxide (ZrO2) frameworks; provides aesthetic dental restorations. Technician applies ceramic powders to framework; material meets ISO 6872:1995 standards for dental ceramics. Output is a finished dental restoration for patient use; aids in restoring dental function and aesthetics.

Clinical Evidence

Bench testing only. Device meets ISO 6872:1995 requirements for dental ceramics.

Technological Characteristics

Dental ceramic powder system; 127 variants including liners, dentines, modifiers, incisals, stains, and glazes. Material properties designed for compatibility with zirconium oxide frameworks having a CTE of approximately 10 x 10^-6 K^-1. Complies with ISO 6872:1995.

Indications for Use

Indicated for use by dental technicians to fabricate all-ceramic dental restorations by veneering zirconium oxide (ZrO2) frameworks with a CTE of approximately 10 x 10^-6 K^-1.

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

• Cerabien ZR Dental Porcelain System (K031968)

Submission Summary (Full Text)

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

JUL 2 2 2005

Premarket Notification 510 (k) Zirox

******************************************************************************************************************************************************************************

Image /page/0/Picture/2 description: The image shows the logo for WIELAND Dental + Technik. The word "WIELAND" is in large, bold, black letters. Below the word "WIELAND" is the phrase "Dental + Technik" in a smaller font.

Wieland Dental + Technik GmbH & Co. KG Schwenninger Straße 13 D-75179 Pforzheim

... . . . . . . . .

.. . . . . . . . . . . . .

Postfach 10 20 40 D-75120 Pforzheim Telefon [phone] Teletax 0 72 31735 79 59

K051249

## 5. 510 (k) Summary

Submitter of 510(k):

Wieland Dental + Technik GmbH & Co. KG Schwenninger Str. 13 D-75179 Pforzheim Germany Phone: [phone]

Contact person: Phone: Fax: e-mail:

Dr. Gerhard Polzer [phone] [phone] [e-mail]

Date of Summary:

2005-04-27

Trade name:

Zirox®

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

Porcelain powder for clinical use EIH 872.6660 Class II

Legally marketed equivalent device:

Cerabien ZR Dental Porcelain System

510(k) number:

K 031968

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

Premarket Notification 510 (k) Zirox

Image /page/1/Picture/1 description: The image shows the word "WIELAND" in large, bold, black letters. Below "WIELAND" is the phrase "Dental + Technik" in a smaller, sans-serif font. The text is horizontally aligned and appears to be a logo or brand name.

Wieland Dental --Technik GmbH & Co. KG Schwenninger Straße 13 D - 15179 Plorzheim

Postlach 10 20 40 1)-75120 Ploczheim Telefon [phone] · 0 Felefax 0 72 317 35 79 59

510 (k) Summary

Device description

Zirox® is a dental porcelain system that consists of 127 different ceramic powders.

lt is intended to be used by professional dental technicians to manufacture all-ceramic dental appliances for the sole use of particular patients.

Zirox® is recommended for veneering zirconium oxide (ZrQ), frameworks, in which it provides an easy to use dental restorative material to fabricate dental restorations with the best possible aesthetic results.

The coefficient of thermal expansion [CTE ۾5-500°C] of these zirconium oxide (ZrO₂) frameworks had to be approximately 10 x 10 6 K1

Zirox® meets all applicable requirements of the standard ISO 6872: 1995 "Dental ceramic".

| Type of Powder | Shades |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Liner | A1; A2; A3; A3,5; A4; B1; B2; B3; B4; C1; C2; C3; C4; D2; D3; D4;<br>White, Yellow, Violet, Orange, Brown, Gum |
| Dentine | A1; A2; A3; A3,5; A4; B1; B2; B3; B4; C1; C2; C3; C4; D2; D3; D4;<br>Crystal 1 light; Crystal 2 pearl; Crystal 3 creme; Gum 1; Gum 2; Gum 3;<br>Gum 4, Gum 5 |
| Chroma-Dentine Chromatix | A1; A2; A3; A3,5; A4; B1; B2; B3; B4; C1; C2; C3; C4; D2; D3; D4 |
| Dentine Modifier | Mocca; Corn; Mango; Caramel; Khaki; Brown; Yellow; Ivory; |
| Flu-Dentines | Flamingo; Straw; Bright; Sunny; Crystal; |
| Incisal / Enamel | Incisal 1, Incisal 2, Incisal 3; Incisal 4;<br>Topas; Anthrazit; Amethist; Aquamarin; Citrin; Rubin; Lemon; Melon;<br>Transpa Neutral; Transpa Clear |
| Opale incisal | Opale Incisal 1, Opale Incisal 2, Opale Incisal 3, Opale Incisal 4,<br>Crystal Blue, Frosty, Milky, Snow, Ice |
| Shoulder porcelains margin | High Flu, High 1, High 2, High 3, High 4, High Red, High Crystal;<br>Low Flu, Low 1, Low 2, Low 3, Low 4, Low 5, Low Bleach |
| Stain | White; Black; Grey; Caramel; Orange; Ocker; Peach; Melon; Blue; Steel;<br>Violet; Gum; Marone; Olive; Ivory; Yellow;<br>Bodystain A; Bodystain B; Bodystain C; Bodystain D |
| Glaze | Glaze |
| Correction | Correction |

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Public Health Service

JUL 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gerhard Polzer Wieland Dental & Technik GMBH & Company KG Schwenninger Strabe 13 D-75179 Pforzheim GERMANY

Re: K051249

Trade/Device Name: ZIROX Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: May 4, 2005 Received: May 16, 2005

Dear Mr. 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.

If your device is classified (see above) into cither 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.

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

Page 2 - Mr. 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); 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. 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,

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

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

## Indications for Use

510(k) Number (if known):

Zirox Device Name:

Indications For Use:

Zirox is a dental ceramic that can be used by dental technicians to fabricate all-ceramic restorations by veneering zirconium oxide (ZrO2) frameworks.

1051249

The coefficient of thermal expansion [CTE (25-500°C) of these zirconium oxide (ZrO₂) frameworks has to equal approximately 10x10*9K1

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Abber DDS for Dr. Susan Runner

(Division Sign-Off) Division of Anesthesiology. General Ho Infection Control, Dental Dev

510(k) Number: K051249

ﻠﺴﻄ Page 1 of