3M M.G. MATERIAL

{0}------------------------------------------------ 3M Dental Products Laboratory 3M Center, Building 260-2B-09 St. Paul, MN 55144-1000 612 733 3149 Jun | | 1998 K98 1325 ## 510(K) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. | Name: | Amy E. Fowler | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | 3M Dental Products Laboratory<br>3M Center, Building 260-2B-12<br>St. Paul, MN 55144-1000 | | Phone: | (612) 736-1590 | | Fax: | (612) 736-0990 | | E-mail: | aefowler@mmm.com | | Date: | April 10, 1998 | | Trade Name: | 3MTM M.G. Material | | Common Names: | Bite registration material, occlusal registration material | | Classification Name: | Impression material<br>(21 CFR 872.3660) Class II | | Predicate devices: | 3MTM ImprintTM II Vinyl Impression Material System<br>3MTM Fast Set Bite Registration Material<br>Heraeus Kulzer MemoregTM C.D. Bite Registration Material<br>Parkell Blu-Mousse® AutoMix Cartridges | 3MTM M.G. Material is designed to make fast, accurate, and rigid interocclusal records. The material has a consistency which resists slumping and offers minimal resistance to closure to ensure proper occlusion. 3M™ M.G. Material may also be used as a matrix material when fabricating custom temporary crowns and bridges. It is a two-part vinyl polysiloxane paste with an addition-cure reaction. The base and catalyst pastes are extruded from dual-barrel cartridges through a mixing tip onto the occlusal surfaces of the teeth. The material quickly cures into a rigid impression. 3MTM M.G. Material is designed for making impressions that record the occlusal relationship of the upper and lower dental arches. It is also intended to be used as a matrix when fabricating temporary crowns and bridges. The predicate devices do not specifically say they are intended for use as matrices. However, the labeling for temporary crown and bridge materials has indirectly indicated the predicate devices for this use for many years. This use does not present any new issues of safety or efficacy. 3MTM M.G. Material and the predicate devices have similar technological characteristics as indicated by their vinyl polysiloxane addition-cure chemistry. This is further validated by the comparative results of the bench tests conducted, including strain in compression, detail reproduction, mixed consistency, and linear dimensional change. Based on the safety analysis and the bench tests, 3MTM M.G. Material is safe, effective, and performs as well or better than the predicate devices. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, arranged in a stacked formation. The profiles are connected and appear to be part of a single, flowing shape. Encircling the design is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN | | 1998 Ms. Amy E. Fowler · Regulatory Affairs 3M Dental Products Laboratory 3M Center, Building 260-2B-09 St. Paul, Minnesota 55144-1000 Re : K981325 3M M.G. Material Trade Name: Regulatory Class: II Product Code: ELW Dated: April 10, 1998 Received: April 13, 1998 Dear Ms. Fowler: 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 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 In addition, FDA may publish further announcements action. 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 {2}------------------------------------------------ Page 2 - Ms. Fowler through 542 of the Act for devices under the Electronic Chrough 542 of the not al provisions, or other Federal laws or requlations. This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your sia wi puivalence of your device to a legally marketed predicate device results in a classification for your marketed produces ormits 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) 594-4692. 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"(21CFR 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/dsma/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Director Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure ... ...... {3}------------------------------------------------ 510(k) Number: Device Name: 3M™ M.G. Material ## Indications For Use: Indications I or Ose. material when fabricating custom temporary crowns and bridges. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) and the state of the state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the s Concurrence of CDRH, Office of Device Evaluation (ODE) | | Susan Runver | |------------------------------|---------------------| | | (Division Sign-Off) | | Division of | | | and General Hospital Devices | | | 510(k) Number | K98 825 | | Prescription Use | <div> (Per 21CFR 801.109) </div> | |------------------|-----------------------------------------| |------------------|-----------------------------------------| OR Over-the Counter Use