← Product Code [EBD](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD) · K974494 # RENAMEL FLOWABLE COMPOSITE (K974494) _Cosmedent, Inc. · EBD · Feb 10, 1998 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K974494 ## Device Facts - **Applicant:** Cosmedent, Inc. - **Product Code:** [EBD](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD.md) - **Decision Date:** Feb 10, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3310 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for Use Renamel Flowable Composite is used for Class V restorations, small occlusal restorations, to seal margins, to repair pitted areas in restorations, as a pit and fissure sealant, to repair marginal defects, for bonding of fibrous splints and for direct resin veneers. ## Device Story Renamel Flowable Composite is a light-cured dental restorative material. Used by dentists in clinical settings to restore tooth structure or repair existing restorations. Applied directly to the tooth surface or restoration site; cured using a dental light-curing unit. Provides a flowable consistency for precise placement in small cavities, fissures, or marginal gaps. Benefits include improved marginal integrity, aesthetic repair of defects, and structural support for splinting. No complex processing or automated analysis involved. ## Clinical Evidence Bench testing only. ## Technological Characteristics Light-cured flowable composite resin. System consists of restorative dental materials. Chemical composition details provided in confidential appendix. No electronic components, software, or connectivity. ## Regulatory Identification A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling. ## 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} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Michael O'Malley President Cosmedent, Incorporated 5419 North Sheridan Road Chicago, Illinois 60640 FEB 10 1998 Re: K974494 Trade Name: Renamel Flowable Composite Regulatory Class: II Product Code: EBD Dated: November 26, 1997 Received: November 28, 1997 Dear Mr. O'Malley: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 {1} Page 2 - Mr. O'Malley through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} Cosmedent, Inc. # INDICATIONS FOR USE STATEMENT 510(K) Number (if known): K974494 Device Name: **Renamel Flowable Composite** Indications for Use: Renamel Flowable Composite is used for Class V restorations, small occlusal restorations, to seal margins, to repair pitted areas in restorations, as a pit and fissure sealant, to repair marginal defects, for bonding of fibrous splints and for direct resin veneers. # DESCRIPTION OF DEVICE Renamel Flowable Composite is a system consisting of light-cured flowable composite restorative dental materials. A confidential chemical analysis of Renamel Flowable Composite may be found in Appendix C. (PLEASE DO NOT WRITE BELOW THIS LINE) ___________________________ (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K974494 Prescription Use ☑ OR Over-the-Counter Use ☐ (Per 21 CFR 801.109) --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K974494](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBD/K974494) **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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