ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES

K080556 · Merz Dental GmbH · EBG · May 2, 2008 · Dental

Device Facts

• Record ID: K080556
• Device Name: ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES
• Applicant: Merz Dental GmbH
• Product Code: EBG · Dental
• Decision Date: May 2, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2

Intended Use

artBloc® Temp is indicated for use with inLab, CEREC or other CAD-controlled milling equipment for the fabrication of multi-unit long-term temporary crowns or bridges.

Device Story

artBloc® Temp is a rectangular solid block of PMMA (polymethyl methacrylate) designed for use in CAD-controlled milling machines (e.g., inLab, CEREC). The device serves as raw material for the fabrication of long-term temporary dental restorations, specifically crowns and bridge abutments. It is intended for use by dental professionals in a clinical or laboratory setting. The milling machine processes the PMMA block based on digital CAD designs to produce the final restoration. The resulting temporary crown or bridge is then placed in the patient's mouth to provide a durable and aesthetic temporary solution during the treatment process.

Clinical Evidence

Bench testing only. Compliance with ISO 10477 (polymer-based crown and bridge materials), ISO 3336 (dentistry-polymeric resin filling materials), and ISO 10993 (biological evaluation of medical devices) was demonstrated.

Technological Characteristics

Material: PMMA (polymethyl methacrylate). Form factor: Rectangular solid block with post attachment. Processing: CAD-controlled milling. Standards: ISO 10477, ISO 3336, ISO 10993.

Indications for Use

Indicated for patients requiring multi-unit long-term temporary crowns or bridges, fabricated via CAD-controlled milling equipment.

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
• VITA CAD-Temp

Submission Summary (Full Text)

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K080556

.

Premarket Notification PMMA Block for CAD-Controlled Milling Machines artBloc® Temp
Merz Dental GmbH

## VIII. Premarket Notification 510(k) Summary

:

| Submitted by: | MAY - 2 2008<br>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) |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Dr. Med Claudia Bobrowski |
| Date prepared: | February 15, 2008 |
| Device proprietary name: | artBloc® Temp |
| Common name: | PMMA Block |
| Classification name: | (21 CFR 872.3330) |
| Predicate devices: | artegral ImCrown<br>and<br>VITA CAD-Temp |
| Description of the device: | A rectangular solid block of PMMA with post<br>attachment for use in a CAD-controlled milling<br>device for production of long-term temporary<br>crowns and bridge abutments. |
| Intended use: | artBloc® Temp is indicated for use with inLab and<br>CEREC milling equipment for the fabrication of<br>multi-unit long-term temporary crowns or bridges. |
| Characteristics: | A solid rectangular block of durable and asthetic<br>polymer (PMMA) that can be easily milled with a<br>CAD-controlled device into a suitable long-term<br>temporary restoration (crown or bridge abutment) |
| Testing: | Tested for compliance to ISO 10477, ISO 3336 and<br>ISO 10993. |

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like bird with its wings spread, rendered in black. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" in all capital letters. The text is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 2 2008

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

Re: K080556 Trade/Device Name: artBloc® Temp Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: February 25, 2008 Received: February 29, 2008

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 (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 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,

Clive Liu, 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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Premarket Notification PMMA Block for CAD-Controlled Milling Machines

ar1Bloc® Temp Merz Dental GmbH

## V. Indications for Use Statement

510(k) Number:

To be assigned

Device Name:

artBloc® Temp

Indications for Use:

artBloc® Temp is indicated for use with inLab, CEREC or other CAD-controlled milling equipment for the fabrication of multi-unit long-term temporary crowns or bridges.

k 6 40 25 €

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)

Summery

Division Sign-Off) livision of Anesthesiology, General Hospital nfection Control, Dental Devices

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10(k) Number: