STRUCTUR 2 SC

K040769 · Voco GmbH · EBG · Apr 7, 2004 · Dental

Device Facts

• Record ID: K040769
• Device Name: STRUCTUR 2 SC
• Applicant: Voco GmbH
• Product Code: EBG · Dental
• Decision Date: Apr 7, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3770
• Device Class: Class 2

Intended Use

cold-polymerizing paste-paste system for the preparation of temporary crowns, bridges, inlays and onlays

Device Story

Structur 2 SC is a cold-polymerizing, paste-paste dental material used by dentists for fabricating temporary crowns, bridges, inlays, and onlays. The system involves mixing two pastes which undergo chemical polymerization to form a temporary restoration. Used in clinical dental settings to provide patients with interim protection and aesthetics while permanent restorations are being fabricated. The output is a hardened resin structure shaped to the patient's dental anatomy.

Clinical Evidence

Bench testing only.

Technological Characteristics

Cold-polymerizing paste-paste resin system. Formulated for manual or automated mixing to initiate polymerization. Class II dental device.

Indications for Use

Indicated for the preparation of temporary crowns, bridges, inlays, and onlays in dental patients requiring temporary 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.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 7 2004

VOCO GmbH C/O Mr. Gerald W. Shipps Cascades Device Consulting Associates 19379 Blue Lake Loop Bend. Oregon 97702

Re: K040769

Trade/Device Name: Structur 2 SC Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: March 23, 2004 Received: March 26, 2004

Dear Mr. Shipps:

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.

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

Page 2 - Mr. Shipps

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/dsma/dsmamain.html

Sincerely vours.

fth h

feo,

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

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

## Indications for Use Statement

510(k) Number: _Ko ப 676 ப பு

Device Name: Structur 2 SC ________

Indications for Use:

cold-polymerizing paste-paste system for the preparation of temporary crowns, bridges, inlays and onlays

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

e Prescription Use

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Robert Betz DDS for Dr. S. Kummer

510(k) Number: KC040769