PRESSX ZR

K070772 · Wieland Dental + Technik GmbH & Co. KG · EIH · Apr 30, 2007 · Dental

Device Facts

• Record ID: K070772
• Device Name: PRESSX ZR
• Applicant: Wieland Dental + Technik GmbH & Co. KG
• Product Code: EIH · Dental
• Decision Date: Apr 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

PressX Zr is a pressable dental ceramic that can be used by dental technicians to fabricate all-ceramic restorations by pressing-over zirconium dioxide frameworks. The indications of these all-ceramic restorations are defined by the manufacturers of the zirconium dioxide (ZrO2) framework material, and normally encompass dental crowns and bridges. The coefficient of thermal expansion [CTE (25 - 500°C]] of these zirconium dioxide (ZrO2) frameworks has to equal approximately 10 x 10°K1 In addition, PressX Zr can be used to manufacture all-ceramic inlays, onlays, and veneers without zirconium dioxide frameworks.

Device Story

PressX Zr is a dental press ceramic system consisting of glass ceramic pellets and porcelain powders. Used by professional dental technicians in a laboratory setting to manufacture all-ceramic dental prostheses. Pellets are pressed onto zirconium dioxide frameworks at high temperatures; restorations are finished via staining (using PressX Zr powders) or layering (using ZIROX powders). Output is a custom dental restoration (crown, bridge, inlay, onlay, or veneer). The device benefits patients by providing durable, aesthetic all-ceramic restorations. Clinical decision-making is supported by the technician's fabrication process based on the framework manufacturer's specifications.

Clinical Evidence

Bench testing only. Evidence includes flexural strength testing per ISO 6872 and fracture resistance testing of standard crowns compared to the predicate device.

Technological Characteristics

Solid glass ceramic (porcelain) pellets and powders. Overpressing technique. Compatible with zirconium dioxide frameworks with CTE ~10 x 10^-6 K^-1. Flexural strength compliant with ISO 6872.

Indications for Use

Indicated for dental technicians to fabricate all-ceramic restorations, including crowns, bridges, inlays, onlays, and veneers. Compatible with zirconium dioxide frameworks (CTE ~10 x 10^-6 K^-1) or as standalone restorations. Contraindications include bruxism.

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.

Reference Devices

• ZIROX (K051249)

Submission Summary (Full Text)

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Premarket Notification 510 (k) PressX Zr

Image /page/0/Picture/1 description: The image shows the word "WIELAND" in large, bold, black letters. Below "WIELAND" is the phrase "Dental + Technik" in a smaller font. The text is horizontally aligned and appears to be a logo or heading.

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

Postfach 20 40 D-75120 Pforzheim Telefon [phone] Telefax 0 72 31/35 79 59

510 (k) Summary

APR 3 0 2007

## Device description

PressX Zr is a dental press ceramic system that is intended to be used by professional dental technicians to manufacture all-ceramic dental prostheses for the sole use of particular patients.

The PressX Zr system consists of solid glass ceramic (porcelain) pellets, which are intended to be pressed onto zirconium dioxide frameworks at high temperature, and of porcelain powders, which are intended to stain these all-ceramic restorations, individually.

After overpressing, the restoration can be finished either by using the staining- or by using the layering-technique. For staining, the PressX Zr powders (Bodystains + Glaze) which are components of the PressX Zr system have to be applied. For lavering, the ZIROX -- powders (a product of Wieland Dental + Technik, K051249) have to be used.

PressX Zr can be pressed onto any zirconium dioxide material, which has a coefficient of thermal expansion [CTE (25-500°C]] of about 10 x 10° K'.

### Indications for use

The indications of the all -ceramic restorations, which are fabricated with zirconium dioxide frameworks and PressX Zr are mainly determined by the specifications of the zirconium dioxide framework materials and are fixed by their manufacturers. Usually, zirconium dioxide frameworks are intended for manufacturing dental crowns and bridges for the anterior and posterior region.

Additionally, PressX Zr can be used to manufacture all-ceramic inlays, onlays, and veneers without zirconium dioxide frameworks.

There is no limitation of the device regarding the patient population, in which commonly known contraindications for all-ceramic restorations, like bruxism, have to be considered by the dentists.

#### Comparison with the predicate device

PressX Zr equals the predicate device with regard to the intended use, material constituents, application process (overpressing technique), recommended framework material, biocompatibility and chemical solubility.

Compared to the predicate device, PressX Zr has a higher flexural strength according to ISO 6872, and "standard crowns" made of PressX Zr have a significantly higher fracture resistance.

For this reason, PressX Zr is at least as safe, as effective and performs as well or better than the predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Dental + Technik GmbH & Co. KG Schwenninger Strasse 13 D-75179 Pforzheim GERMANY

APR 3 0 2007

Re: K070772

Trade/Device Name: PressX Zr Regulation Number: 21 CFR 872,6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: March 16, 2007 Received: March 21, 2007

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 Novinatio Act (Act) that do not require approval of a premarket approval application (PMA). Tour 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 -- Dr. Gerhard 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 (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.

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" (21 CFR 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 S. Lin, PhD

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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# Indications for Use

510(k) Number (if known): k070772

Device Name: PressX Zr

Indications for Use:

PressX Zr is a pressable dental ceramic that can be used by dental technicians to fabricate all-ceramic restorations by pressing-over zirconium dioxide frameworks. The indications of these all-ceramic restorations are defined by the manufacturers of the zirconium dioxide (ZrO2) framework material, and normally encompass dental crowns and bridges.

The coefficient of thermal expansion [CTE (25 - 500°C]] of these zirconium dioxide (ZrO2) frameworks has to equal approximately 10 x 10°K1

In addition, PressX Zr can be used to manufacture all-ceramic inlays, onlays, and veneers without zirconium dioxide frameworks.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Quapo

thesiology, General Hospit

K002722

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(Posted November 13, 2003)