← Product Code [EMA](/productcode/EMA) · K070840 # GVC-100 (K070840) _GC America, Inc. · EMA · May 15, 2007 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K070840 ## Device Facts - **Applicant:** GC America, Inc. - **Product Code:** [EMA](/productcode/EMA.md) - **Decision Date:** May 15, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3275 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for Use GVC-100 is a radiopaque light-cured resin-based luting cement for porcelain (or composite) laminate veneer or inlay restoration. ## Device Story GVC-100 is a radiopaque, light-cured, resin-based luting cement. It is used by dental professionals in a clinical setting to bond porcelain or composite laminate veneers and inlay restorations to tooth structure. The device functions as a restorative material to secure dental prosthetics. It is applied by the clinician during the restorative procedure. ## Clinical Evidence No clinical data provided; substantial equivalence determination based on regulatory classification and device description. ## Technological Characteristics Resin-based luting cement; light-cured; radiopaque. Class II device per 21 CFR 872.3275(b). ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black and white design. The text is in all capital letters and is also in black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Terry L. Joritz-Lyons Director -- Regulatory Affairs and Quality Assurance GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803 MAY 15 2007 Re: K070840 Trade/Device Name: GVC-100 Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: March 20, 2007 Received: March 27, 2007 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 (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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on vour responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Sylvie G. Michael, M.D. Chris S. Liou, Ph.D. 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 K070840 GVC-100 510(k) Number (if known): Device Name: Indications for Use: > cement for porcelain (or composite) laminate veneer or inlay restoration. 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) Susan Runner Page 1 of 1 sion of Anesthesiology, General Hospital, John Control, Dental Devices i C(k) Number KO 1 GVC-100 is a radiopaque light-cured resin-based luting --- **Source:** [https://fda.innolitics.com/device/K070840](https://fda.innolitics.com/device/K070840) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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