SYSTEMP.C&B PLUS

K042820 · Ivoclar Vivadent, Inc. · EBG · Dec 14, 2004 · Dental

Device Facts

• Record ID: K042820
• Device Name: SYSTEMP.C&B PLUS
• Applicant: Ivoclar Vivadent, Inc.
• Product Code: EBG · Dental
• Decision Date: Dec 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For the fabrication of temporary crowns and bridges until the permanent restoration can be delivered.

Device Story

Systemp.c&b Plus is a dental resin material used for the fabrication of temporary crowns and bridges. It is intended for use by dental professionals in a clinical setting to provide interim restorations while permanent crowns or bridges are being manufactured. The device functions as a restorative material, allowing clinicians to create temporary structures that protect prepared teeth, maintain space, and provide aesthetics and function until the final restoration is ready for placement. It is a manual-application dental material.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Temporary crown and bridge resin material. Class II device under 21 CFR 872.3770. Product code EBG.

Indications for Use

Indicated for the fabrication of temporary crowns and bridges in patients requiring interim restorations prior to the delivery of permanent dental prosthetics.

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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2004

Ms. Donna Marie Hartnett Director of Quality Assurance/Regulatory Affairs Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

Re: K042820

Trade/Device Name: Systemp.c&b Plus Regulation Number: 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: October 7, 2004 Received: October 13, 2004

Dear Mr. Hartnett:

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. Hartnett

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,

Chiu Lin, 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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## Indications for Use

510(k) Number (if known): K042826

Device Name: Systemp.c&b Plus Indications For Use:

## Intended Use:

Intended Use:
For the fabrication of temporary crowns and bridges until the permanent restoration can be delivered.

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: _______________________________________________________________________________________________________________________________________________________________