ARTEGRAL IMCROWN

K061809 · Merz Dental GmbH · EBG · Sep 13, 2006 · Dental

Device Facts

• Record ID: K061809
• Device Name: ARTEGRAL IMCROWN
• Applicant: Merz Dental GmbH
• Product Code: EBG · Dental
• Decision Date: Sep 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

artegral® ImCrown is indicated for use as a provisional anterior crown when fitted with the CEREC 3D and inLab Systems

Device Story

artegral® ImCrown consists of preformed anterior crowns made of IPN-PMMA (Interpenetrating Polymer Network Polymethyl Methacrylate). The device features an integrated attachment mechanism designed for compatibility with CEREC 3D and inLab dental CAD/CAM systems. Used by dental professionals in clinical settings to provide temporary anterior restorations. The crowns are selected based on shape and size to fit the patient's dentition, facilitating the provisional phase of restorative dental treatment.

Clinical Evidence

Bench testing only. Compliance with ISO 3336 (dentistry-based performance standards for crown and bridge materials) and ISO 10993 (biocompatibility) was demonstrated.

Technological Characteristics

Material: IPN-PMMA (Interpenetrating Polymer Network Polymethyl Methacrylate). Form factor: Preformed anterior crowns with attachment device for CAD/CAM systems. Standards: ISO 3336, ISO 10993. Energy source: None (mechanical).

Indications for Use

Indicated for use as a provisional anterior crown in patients requiring temporary anterior 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

• Temporary Crown and Bridge Resin (no specific 510(k) number provided)

Submission Summary (Full Text)

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K061809

Premarket Notification Preformed Crown

artegral® ImCrown Merz Dental GmbH

## 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) |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Dr. Med Claudia Bobrowski |
| Date prepared: | June 23, 2006 |
| Device proprietary name: | artegral® ImCrown |
| Common name: | Temporary Crown and Bridge Resin |
| Classification name: | Temporary Crown and Bridge Resin<br>(21 CFR 872.3770) |
| Predicate devices: | Temporary Crown and Bridge Resin |
| Description of the device: | Various shapes and sizes of preformed anterior<br>crowns composed of IPN-PMMA with an<br>attachment device for use in the CEREC 3D and<br>inLab Systems. |
| Intended use: | artegra® ImCrown is indicated for use as a<br>provisional anterior crown when fitted with the<br>CEREC 3D and inLab Systems |
| Characteristics: | A preformed anterior crown suitable for anterior<br>provisional restorations. |
| Testing: | Tested for compliance to ISO 3336 and ISO 10993. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming the staff and a snake winding around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 1 3 2006

Merz Dental GmbH C/O Mr. Richard G. Hunter Principal Washington Regulatory Consultants 4235 Providence Lane Tucker, Georgia 30084

Re: K061809

Trade/Device Name: Artegral ImCrown Regulation Number: 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: June 23, 2006 Received: June 27, 2006

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 vour 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,

Chris 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 Preformed Crown

artegral ImCrown Merz Dental GmbH

V. Indications for Use Statement K0611809

510(k) Number:

To be assigned

Device Name:

artegral ImCrown

Indications for Use:

artegral ImCrown is indicated for use as a provisional anterior crown when fitted with the CEREC 3D and inLab.

Prescription Use X (Part 21 CFR 801 Sūbpart D)

AND/C)R

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

(PLEASE DO NOT WRITE BELOW THIS LINE-

Concurrence of CDRH, Office of Device Evaluation (ODE)

Surer Rumer

v. General Hospital.

K061809

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