WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED

K071548 · Merz Dental GmbH · EBG · Aug 21, 2007 · Dental

Device Facts

• Record ID: K071548
• Device Name: WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED
• Applicant: Merz Dental GmbH
• Product Code: EBG · Dental
• Decision Date: Aug 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2

Intended Use

For use as a milling blank in the fabrication of provisional crowns and bridges.

Device Story

Wieland Zeno CAO temporary PMMA disc is a tooth-colored polymethyl methacrylate (PMMA) material supplied in disc form. It serves as a raw material for dental laboratories to mill into provisional crowns and bridges using CAD/CAM systems. The device provides strength, dimensional stability, and esthetic properties suitable for temporary dental applications. It is intended for professional use by dental technicians or clinicians to create custom-fit temporary restorations.

Clinical Evidence

Bench testing only. Compliance with ISO 3336 and ISO 10993 standards for dental materials and biocompatibility was demonstrated.

Technological Characteristics

Material: Polymethyl methacrylate (PMMA) disc. Form factor: Circular discs in two sizes and three shades. Standards: ISO 3336 (dental base polymers) and ISO 10993 (biocompatibility).

Indications for Use

Indicated for use as a milling blank in the fabrication of provisional crowns and bridges for patients requiring temporary dental restorations.

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Predicate Devices

• artegral® ImCrown, Merz Dental (K061809)
• Temporary Crown and Bridge Material, Dentsply International (K060293)

Submission Summary (Full Text)

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K071548

Premarket Notification Temporary Crown and Bridge Material

:

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Merz Dental GmbH Lütjenburg, Germany

## VIII. Premarket Notification 510(k) Summary

| Submitted by: | Merz Dental GmbH<br>Eetzweg 20<br>D-24321 Lutjenburg<br>Germany<br>0 43 81/4 03-4 11 (phone)<br>0 43 81/4 09-1 07 (fax)<br>AUG 2 1 2007 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Dr. Med Claudia Bobrowski |
| Date prepared: | June 1, 2007 |
| Device proprietary name: | Wieland Zeno CAO temporary PMMA disc,<br>tooth-colored |
| Common name: | PMMA Crown and Bridge Material |
| Classification name: | Temporary Crown and Bridge Resin<br>(21 CFR 872.3770) |
| Predicate devices: | artegral® ImCrown,<br>Merz Dental (K061809)<br>Temporary Crown and Bridge Material,<br>Dentsply International (K060293) |
| Description of the device: | Discs of PMMA in two sizes and three shades<br>for milling into provisional crowns and bridges |
| Intended use: | For use as a milling blank in the fabrication of<br>provisional crowns and bridges. |
| Characteristics: | An ideal material for the fabrication of<br>provisional crowns and bridges because of its<br>strength, ease of milling, dimensional stability,<br>and natural esthetic. |
| Testing:<br>10993 | Tested for compliance to ISO 3336 and ISO |

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Image /page/1/Picture/11 description: The image shows a circular seal or logo. The text around the top of the circle reads "HUMAN SERVICES - USA". The text around the bottom of the circle reads "DEPARTMENT OF HEALTH & ". Inside the circle is a stylized graphic, possibly representing a flag or a symbol of the department.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 1 2007

Merz Dental GmbH C/O Mr. Richard G. Hunter Principal Washington Regulatory Consultants 5616 Mariola Place, NE Albuquerque, New Mexico 87111

Re: K071548

Trade/Device Name: Wieland Zeno CAO Temporary PMMA Disc, Tooth-Colored Regulation Number: 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: August 3, 2007 Received: August 13, 2007

Dear Mr. Hunter:

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. Hunter

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

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Merz Dental GmbH Lütjenburg, Germany

## V. Indications for Use Statement

510(k) Number: To be assigned K071548

Device Name:

Wieland Zeno CAO temporary PMMA disc, tooth-colored

Indications for Use:

For use as a milling blank in the fabrication of provisional crowns and bridges.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart ) ________________________________________________________________________________________________________________________________________________________

## (PLEASE DO NOT WRITE BELOW THIS LINE-

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Susar Runne |
|-----------------------------------------------|-------------|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K071548 |

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