3M LVR SYSTEM

{0}------------------------------------------------ AUG. 2. 1999 1:37PM AUG -- 9 1999 ## 510(k) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1980 and 21 CFR \$807.92. | Name: | Lael J. Pickett | | |----------------------|-----------------------------------------------------|--| | | Regulatory Affairs Specialist | | | Address: | 3M Dental Products Laboratory | | | | 3M Center, Building 260-2B-12 | | | | St. Paul, MN 55144-1000 | | | Telephone: | 612-733-3594 | | | Fax: | 612-736-0990 | | | Trade Name: | 3M™ LVR System | | | Common Names: | Tooth shade resin material, light cure restorative | | | | Resin cement, luting composite, luting cement | | | | Dental sealant, pit and fissure sealant. | | | Classification Name: | 21 CFR § 872.3690 Tooth Shade Resin Material | | | | 21 CFR § 872.3275 Dental cement, Class II. | | | | 21 CFR § 872.3765 Pit and fissure sealant, Class II | | | Predicate Devices: | DYRACT® FLOW, DENTSPLY Caulk | | | | AELITEFLO™, Bisco Dental Products | | | | Revolution Flowable Paste Product, Kerr Corp. | | | | TETRIC® FLOW Flowable Ceromer, Ivoclar Vivadent | | 3M™ LVR System is a single part, light curing restorative composite. This device, as well as the predicate devices, are based on methacrylate resin chemistry incorporating an inorganic filler. The 3M™ LVR System can be used as a: baselliner under direct restorations, pit and fissure sealant, veneer cement, undercut blockout, restorative for minimal - shallow Class V preparations, restorative for minimally invasive cavity proparations (including air abrasion and tunnel preparations), repair of small defects in composite and ceramic indirect restorations (including veneers, inlays, crowns and bridges), repair of small marginal defects in direct restorations and for repair of acrylic temporary marginal defects. This product can be used for both anterior and posterior restorations and functions as a permanent veneer cement. 3M™ LVR System and predicate devices have similar technological characteriatios as indicated by their methacrylate resin chemistry. This is further validated by the comparative results of the bench tests conducted. These tests include Watts shrinkage, wear resistance, compressive strength, diametral tensile strength, film thickness, Thermal Expansion Coefficient, flow and water sorption. The 3M™ LVR System also meets ISO 4049-1988 "Dentistry - Resin-based filling materials". Based on the conclusions drawn from the safety analysis conducted for this device and the results of the bench testing, 3M™ LVR System II Plus is safe, effective and performs as well or better than the predicate devices mentioned above. 3M™ LVR System K991961 August 2, 1999 {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-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG - 9 1999 Mr. Lael J. Pickett Regulatory Affairs Specialist 3M Dental Products Laboratory 3M Center, Building 260-2B-09 St. Paul, Minnesota 55144-1000 K991961 Re: 3MTM LVR SYSTEM Trade Name: Requlatory Class: II Product Code: EBF Dated: June 2, 1999 Received: June 10, 1999 Dear Mr. Pickett: We have reviewed your Section 510(k) notification of intent to we have reviewed your below and we have determined the market the device relies suivalent (for the indications for use device is substancially equilies (marketed in interstate commerce scated in the Cholorals, is enactment date of the Medical Device prior to hay 20, 1970) one base been reclassified in accordance Amendicites) or oo of the Federal Food, Drug, and Cosmetic Act You may, therefore, market the device, subject to the (Act). (Acc). Tod may) choresons of the Act. The general controls general concrors provisions e requirements for annual registration, proving 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 (Spectur controls) Stronal 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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. Pickett This letter will allow you to begin marketing your device as Inis lected will arrow you ou begdescribed in your stow, promise of your device to a legally marketed of Subscuncial equivalisin a classification for your device and thus, permits your device to proceed to the market. enab, Delmire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in xitro reguration (ar orn), please contact the Office of Compliance at (1801) 594-4692. Additionally, for questions on the promotion and (301) 394-4022. Addressmarly) ase contact the Office of Compliance Also, please note the regulation entitled, at (301) 594-4639. "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under 807.97) . . our. The ocher general from the Rivision of Small Manufacturers ene may be obsolisfree number (800) 638-2041 or (301) 443-6597 Assistance ac Its Coll Irec namby (voo) (voo) (voo) 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 Radioloqical Health Enclosure {3}------------------------------------------------ 510(k) Number (if known): K991961 Device Name: 3M™ LVR System_ Indications For Use: This device is indicated for: - Base/liner under direct restorations . - Pit and fissure sealant . - Veneer Cementation . - Undercut blockout ● - Restoration of minimal, shallow, Class V preparations ● - Restoration of minimally invasive cavity preparations, including air abrasion and tunnel . preparations - . Repair of small defects in composite and ceramic indirect restorations including veneers, inlays, onlays, crowns and bridges - . Repair of small marginal defects in direct restorations - Repair of acrylic temporary marginal defects . (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | | Concurrence of CDRH, Office of Device Evaluation (ODE) | | | | |------------------------------------------|--------------------------------------------------------|----|----------------------|--| | Prescription Use<br>(Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter Use | | | August 2, 1999 | (Division Sign-Off)<br>Division of Dental, Infection Control,<br>and General Hospital Devices | Page x | |----------------|-----------------------------------------------------------------------------------------------|--------| | 510(k) Number | K99961 | |