MODIFICATION TO ALLOY PRIMER

{0}------------------------------------------------ ## INC. I Material Department , 1-Chome, Umeda, Kita-ku, Osaka 530-8611, JAPAN 81-6-348-2603 K012436 # SEP - 4 2001 # 510(k) SUMMARY ### 1. Submitter | 1) Name | KURARAY MEDICAL INC. | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan | | 3) Contact person | Koji Nishida<br>DENTAL MATERIAL DEPARTMENT | | 4) Date | July 23, 2001 | | 5) Contact person in U.S.A. | Masaya Sasaki<br>30th Fl. Metlife Building, 200 Park Avenue, New York<br>NY 10166<br>Telephone : (212)-986-2230<br>1(800)-879-1676<br>Facsimile : (212)-867-3543 | #### 2. Name of Device | 1) Proprietary Name | ALLOY PRIMER | |------------------------|--------------------------------------------| | 2) Classification Name | Resin tooth bonding agent (21CFR 872.3200) | | 3) Common/Usual Name | Metal adhesive primer | ### 3. Predicate device: Kuraray Co., Ltd. will transfer the medical device business and the relevant functions including manufacturing facilities to its subsidiary company named Kuraray Medical Inc. on October 1st 2001. The aim of 510(k) submission is to alter the name and address of manufacturer, and not to intend other changes. The predicate device is as follow. 1. ALLOY PRIMER by Kuraray Co., Ltd. (K974089) ### 4. Description for the premarket notification ALLOY PRIMER is an adhesion primer between dental metal alloy and resin-based material for dental practitioner or dental technician, and comprises methacrylate monomers and solvent. It is used a kind of bonding agent between metal and/or tooth substrate using resin-based materials for the intended uses. Therefore this product is classified into the resin tooth bonding agent, CFR 21 Section 872.3200. {1}------------------------------------------------ #### 5. Statement of the intended use The intended uses of this device are as follows. They are completely the same as ALLOY PRIMER manufactured by Kuraray Co., Ltd. (K974089). - 1) Adhesion of metal posts, metal inlays, onlays, crown and bridges. - 2) Repair of fractures resin-based facing crowns and porcelain-fused metal crowns - 3) Fabrication of removable dentures with metal base, clasp or attachment. Repair of dentures #### 6. Statement of the technological characteristics and safety This device is essentially the same as ALLOY PRIMER manufactured by Kuraray Co., Ltd. Therefore the technological characteristics, chemical ingredients and safety of this (K974089). device are completely the same as ALLOY PRIMER. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP = 4 2001 Kuraray Medical, Incorporated C/O Ms. Masaya Sasaki Kuraray America, Incorporated 30th Floor Metlife Building 200 Park Avenue 10166 New York, New York K012436 Re : Modification To Alloy Primer Trade/Device Name: 872.3200 Requlation Number: Regulatory Class: II Product Code: KLE Dated: July 23, 2001 Received: July 31, 2001 Dear Ms. Sasaki: We have reviewed your Section 510(k) notification of intent to we have levice your boosed above and we have determined the market the device force enouvalent (for the indications for use stated in the enclosure) to legally marketed predicate use stated in the cholobase, commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to the chactment acco on reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). provisions of the reachar robe, subject to the general The general controls controls provisions of the Act. provisions of the Act include requirements for annual provisions of the not includes, 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 (operai ochorsuch additional controls. Existing major be subject to back acabour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ rederal &chartially eroses mination assumes compliance with Bubbeancially oqualizaturing Practice requirements, as set Enc Current Souality 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 Aomilitocracion (CMP regulation may result in regulatory In addition, FDA may publish further announcements action. {3}------------------------------------------------ Page 2- Ms. Sasaki concerning your device in the Federal Register. Please note: concerning your device in ence innotification submission does this response to your premarker needbase under sections 531 not affect any obligation you might have under the Electronic not allect any obligation you mages under the Electronic through 542 of the Act for acvices ander of other Federal laws or regulations. This letter will allow you to begin marketing your device as Inis recei will arrow your of the motification. The FDA described in your 510 kr premaince of your device to a legally finding of substancial equivalence of polassification for your marketed predicate device rebares in opened to the market. If you desire specific advice for your device on our labeling II you desire specific advice is do and additionally 809.10 for in regulation (21 crk Fare Son and Son and the Office of Compliance at (301) 594-4613. Additionally, for questions on Compliance at (501) 331 issing of your device, please contact the promocion and advercibing on Journal (301) Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general premarket notification - (2rch Joies under the Act may be Informacion on your rision of Small Manufacturers, obtained from the Division of Email - Bilained at its tollefreeddress International and Consumer-ABB-ABB-Aits Internet address (800) 636-2041 Szvirgdrh/dsma/dsmamain.html. Sincerely yours, Timothy A. Ulatowski Tim Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ [ALLOY PRIMER, Kuraray Medical Inc.] Image /page/4/Picture/1 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the digits '0', '1', '2', '4', '3', and '6'. The digits are written in a clear, legible style, with consistent spacing between them. The image appears to be a close-up of the handwritten sequence. 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: ALLOY PRIMER ## Indications for Use Statement of the intended use ALLOY PRIMER is indicated for the following applications: 1) Adhesion of metal posts, metal inlays, onlays, crown and bridges 2) Repair of fractures resin-based facing crowns and porcelain-fused metal crowns 3) Fabrication of removable dentures with metal base, clasp or attachment. Repair of dentures (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use_ (Part 21 CFR 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _