GC XLC-100 CAPSULE

K061535 · GC America, Inc. · EMA · Jul 14, 2006 · Dental

Device Facts

• Record ID: K061535
• Device Name: GC XLC-100 CAPSULE
• Applicant: GC America, Inc.
• Product Code: EMA · Dental
• Decision Date: Jul 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

GC XLC-100 is a radiopaque, dual-curing, self-adhesive resin cement in capsulated form for cementing metal, porcelain fused to metal, resin and ceramic restorations.

Device Story

GC XLC-100 Capsule is a dental cement used by dental professionals for the permanent cementation of various dental restorations, including metal, porcelain-fused-to-metal, resin, and ceramic crowns, bridges, inlays, and onlays. The device is supplied in a capsulated form, which is activated and mixed using a mechanical amalgamator before application. The material is dual-curing, meaning it can be set via chemical reaction or light activation. Once applied to the restoration and the prepared tooth surface, the cement bonds the restoration to the tooth structure. The radiopaque nature of the material allows for visualization on dental radiographs to verify cement margins and detect excess material. By providing a secure, self-adhesive bond, the device aids in the retention and marginal seal of dental restorations, potentially improving the longevity and clinical success of the prosthetic treatment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Radiopaque, dual-curing, self-adhesive resin cement. Supplied in pre-dosed capsules for mechanical mixing. Material properties include chemical and light-curing capabilities for polymerization. No specific ASTM standards or software components described.

Indications for Use

Indicated for the cementation of metal, porcelain fused to metal, resin, and ceramic dental restorations in patients requiring restorative dental procedures.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 2006

Ms. Terry L. Joritz-Lyons Director - Customer Care Group GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803

Re: K061535

Trade/Device Name: GC XLC-100 Capsule Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: May 18, 2006 Received: June 02, 2006

Dear Ms. Joritz-Lyons:

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 - Ms. Terry L. Joritz-Lyons

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 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,

Aryite Y. Hickinoms

Chiu S. Lin, PhD 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

14061535 510(k) Number (if known):

Device Name: GC XLC-100 Capsule

## Indications for Use:

GC XLC-100 is a radiopaque, dual-curing, self-adhesive resin cement in capsulated form for cementing metal, porcelain fused to metal, resin and ceramic restorations.

Prescription Use
(21 CFR Part 801 Subpart D)
✓

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kai Muly for MSR

ign-Off)
on of Anesthesiology, General Hospital,
ion Control, Dental Devices