DYTRACT FLOW RESTORATIVE

{0}------------------------------------------------ AUG 18 1998 K982395 # 510(k) SUMMARY DENTSPLY #### NAME & ADDRESS: #### DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 Fax 17171 854-2343 P. J. Lehn Telefax (717) 849-4343 P. Jeffery Lehn CONTACT: JUL 0 8 1998 DATE PREPARED: TRADE OR PROPRIETARY NAME:DYRACT® FLOW RESTORATIVE COMMON OR USUAL NAME: Dental restorative material | CLASSIFICATION NAME: | Tooth shade resin material | 872.3690 | |----------------------|------------------------------------------------|--------------------| | PREDICATE DEVICE: | Dyract® AP™ Restorative<br>Aeliteflo Composite | K973235<br>K955292 | DEVICE DESCRIPTION: DYRACT® FLOW RESTORATIVE is a one-component, moderately filled, visible light cured dental composite restorative material. DYRACT® FLOW RESTORATIVE is a low viscosity, esthetic material for use as a composite restorative. It is a moderately filled, radiopaque, fluoride-releasing composite, primarily designed for restoration of shallow defects such as incipient Class V lesions. The physical properties of DYRACT® FLOW RESTORATIVE meet ISO Standard 4049. 117 2017 INTENDED USE: DYRACT® FLOW RESTORATIVE is used for: Filling of defects and undercuts in crowns, inlays; Liner under direct restorative materials and under inlay restorations-Class II box liner; Tunnel preparations; Pit and fissure sealants; Amalgam margin repair; Improving margins of acrylic temporaries; Small class IV repairs; Intraoral porcelain repair; Cementing porcelain veneers, crowns, inlays/onlays; Refacing acrylic temporaries; Blockouts; Covering incisal edge stains; Repair of small enamel defects; Provisional occlusal changes; Class III, V restorative Class I restorations; and Margin correction/adjustment of composite crowns for indirect laboratory use. TECHNOLOGICAL CHARACTERISTICS: All of the components found in DYRACT® FLOW RESTORATIVE have either been used in predicate dental devices or have been found safe for dental use. We believe that the prior use of the components of DYRACT® FLOW RESTORATIVE in legally marketed predicate devices, the performance data, and the biocompatibility data provided support the safety and effectiveness of DYRACT® FLOW RESTORATIVE for the indicated uses. 000015 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 8 1998 Mr. P. Jeffrey Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872 Re: K982395 Trade Name: Dyract® Flow Restorative Requlatory Class: II Product Code: EBF Dated: July 8, 1998 Received: July 9, 1998 Dear Mr. Lehn: 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, 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 Requlations, Title 21, Parts 800 to 895. ਚੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {2}------------------------------------------------ Page 2 - Mr. Lehn 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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, S. Putman for Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## PREMARKET NOTIFICATION ## INDICATIONS FOR USE STATEMENT (As Required by 21 CFR 801.109) 510(K) Number: Image /page/3/Picture/4 description: The image shows a sequence of handwritten characters. The characters are 'K982395'. The characters are written in a simple, clear style, and they are all connected by a line underneath. Device Name: ### DYRACT® FLOW RESTORATIVE - Filling of defects and undercuts in crowns, inlays and onlays; ● - Liner under direct restorative materials and under inlay restorations--Class II box liner; - . Tunnel preparations; - Pit and fissure sealants; ● - Amalgam margin repair; Improving margins of acrylic temporaries; - . Small class IV repairs; - . Intraoral porcelain repair; - . Cementing porcelain veneers, crowns, inlays/onlays; - Refacing acrylic temporaries; - . Blockouts: - . Covering incisal edge stains; - Repair of small enamel defects; . - . Provisional occlusal changes; - Class III, V restorations; ● - . Conservative Class I restorations; - . Margin correction/adjustment of composite crowns for indirect laboratory use Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Surya Raoor (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device KK 510(k) Number 000007