ESTECEM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 17, 2015 Tokuyama Dental Corporation c/o Mr. Keith A. Barritt Fish & Richardson P.C. 1425 K Street NW Suite 1100 Washington, DC 20005 Re: K150727 Trade/Device Name: ESTECEM Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: March 13, 2015 Received: March 20, 2015 #### Dear Mr. Barritt: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours. Image /page/1/Picture/8 description: The image shows a signature that reads "Tina Kiang-S". The signature is written in a cursive style, with the first name "Tina" appearing above the last name "Kiang-S". There is a large looping design to the left of the name. The signature is in black ink on a white background. for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K150727 Device Name ESTECEM #### Indications for Use (Describe) The ESTECEM device is an adhesive resin cementation of crowns, bridges, inlays, and onlays made of glass/oxide ceramics (porcelain, zirconia and alumina), metals/alloys (precious) and resin materials including inorganic filler (composite materials). The ESTECEM device is indicated for: - Repair of fractured porcelain fused to metal crowns and all ceramic restorations - Cementation of veneers - Cementation of adhesion bridges - Cementation of metal or resin cores, metal or glass-fiber posts Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) SUMMARY Tokuyama Dental Corporation # ESTECEM Adhesive Resin Cement The following information is provided pursuant to 21 CFR 807.92. # 807.92(a)(1): Submitter's Name and Address # (i) 510(k) Submitter Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo 110-0016 Japan Phone: 011-81-3-3835-2261 # (ii) 510(k) Submitter Contact Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331 barritt@fr.com Email: # (iii) Preparation Date March 9, 2015 # 807.92(a)(2): Name of Device Trade or Proprietary Name: Common Name: Classification Name: Product Code: Regulation: ESTECEM dental adhesive resin cement cement, dental EMA 21 CFR 872.3275 {4}------------------------------------------------ #### 807.92(a)(3): Predicate Devices The ESTECEM adhesive resin cement device is substantially equivalent for purposes of FDA medical device regulations to multiple predicate devices with respect to performance and biocompatibility. namely to the Primary Predicate BISTITE II DC (K#011685, Health Canada license no. 60061) and Reference Devices CLEARFIL ESTHETIC CEMENT & DC BOND (K#062410, Health Canada license no. 73128); MULTILINK AUTOMIX (K#123397, Health Canada license no. 79221); and DUOLINK II (K#101787, Health Canada license no. 30968). Additional information regarding the predicate devices appears at the end of this 510(k) Summary. #### 807.92(a)(4): Device Description The ESTECEM device is a dual-cure (light and/or self-cure), radiopaque, adhesive resin cement system with excellent handling, esthetic and adhesive properties to teeth and all prosthetic materials. The main components of the ESTECEM device are (1) the paste (A/B) and (2) primer kit. The paste and primer are packaged in plastic syringes and plastic bottles, respectively. The device also comes with a mixing dish (dispensing well), disposable applicator, and cement mixing tip. The paste is dispensed in an automix syringe and is available in various shades (universal, clear, brown and white-opaque). The primer kit components consist of ESTELINK (bond A/bond B) and Tokuyama Universal Primer (A/B). The ESTELINK bond promotes the adhesion of the paste to the tooth structure. The Tokuyama Universal Primer enhances the adhesion of the paste to prosthetic materials. The ESTECEM device does not come sterilized and is not intended to be sterilized prior to use. #### 807.92(a)(5): Intended Use The ESTECEM device is an adhesive resin cement for the cementation of crowns, bridges, inlays, and onlays made of glass/oxide ceramics (porcelain, zirconia and alumina), metals/alloys (precious and non-precious) and resin materials including inorganic filler (composite materials). The ESTECEM device is indicated for: - Repair of fractured porcelain fused to metal crowns and all ceramic restorations - Cementation of veneers - Cementation of adhesion bridges - Cementation of metal or resin cores, metal or glass-fiber posts {5}------------------------------------------------ # 807.92(a)(6): Technological Characteristics The ESTECEM device has the same basic technological characteristics in terms of design, material, and chemical composition as the predicate devices identified above. The ESTECEM device does not have an energy source. Although the chemical compositions are not identical, the material properties, principles of operation, and performance characteristics of the ESTECEM device are comparable to the selected predicates, as demonstrated in part by the non-clinical performance bench testing described below. # 807.92(b)(1): Non-clinical Testing Non-clinical testing of the physical properties of the ESTECEM device were conducted, including film thickness, working time, setting time, flexural strength, water sorption. color stability, radio-opacity, tensile strength, and biocompatibility testing in accordance with ISO 4049:2009, ISO 7405:2008, and ISO 10993-1:2009, ISO 10993-3 (genotoxicity), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and irritation), and ISO 10993-11 (systemic toxicity). # 807.92(b)(2): Clinical Testing There were no clinical tests performed for the ESTECEM device. # 807.92(b)(3): Conclusions from Testing Based on the non-clinical testing conducted of the physical properties of the ESTECEM device and the biocompatibility testing as described above, it is concluded that the ESTECEM device is as safe, as effective, and performs as well as or better than the predicate devices. {6}------------------------------------------------ # Predicate devices | Device name | ESTECEM | BISTITE II DC | CLEARFIL<br>ESTHETIC CEMENT<br>& DC BOND 1) | MULTILINK<br>AUTOMIX | DUOLINK II 2) | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Tokuyama Dental<br>Corporation | Tokuyama Dental<br>Corporation | Kuraray Noritake<br>Dental Inc. | Ivoclar Vivadent AG | Bisco, Inc. | | 510(K) no. | pending | K011685 | K062410 | K123397 | K101787 | | Licence no.<br>(Health<br>Canada) | pending | 60061 | 73128 | 79221 | 30968 | | Device<br>classification<br>name | Cement, Dental | Cement, Dental | Cement, Dental | Material, Tooth Shade,<br>Resin | Cement, Dental | | Product code | EMA | EMA | EMA | EBF | EMA | | Indication for<br>use | 1. Cementation of crowns,<br>bridges, inlays, and onlays<br>made of glass/oxide ceramics<br>(porcelain, zirconia and<br>alumina), metals/alloys<br>(precious and non-precious)<br>and resin materials including<br>inorganic filler (composite<br>materials)<br>2. Repair of fractured<br>porcelain fused to metal<br>crowns and all ceramic<br>restorations<br>3. Cementation of veneers<br>4. Cementation of adhesion<br>bridges<br>5. Cementation of metal or<br>resin cores, metal or glass-<br>fiber posts | For use as dental cement in<br>various applications,<br>including luting, repair of<br>fractured porcelains or crown<br>and bridge resins, cementation<br>of adhesive bridge prostheses<br>and CR core posts | 1. Cementation of crowns,<br>bridges, inlays and onlays<br>made of porcelain, ceramic,<br>hybrid ceramics, composite<br>resin or metal<br>2. Cementation of veneers<br>3. Cementation of adhesion<br>bridges<br>4. Cementation of metal cores,<br>resin cores, metal posts or<br>glass-fiber posts | Multilink Automix is used for<br>the permanent cementation of<br>indirect restorations where a<br>strong bond is desired:<br>Inlays, onlays, crowns,<br>bridges and root posts made<br>of:<br>- Metal and metal ceramics<br>- All-ceramics, in particular<br>opaque zirconium oxide<br>ceramics<br>- Composites and fibre-<br>reinforced composites | 1. All indirect restorations (i.e.<br>crowns.<br>bridges, inlay, and onlays<br>fabricated from<br>metal composite, porcelain,<br>ceramic, zirconia, alumina,<br>etc.)<br>2. All endodontic posts (i.e.<br>fiber, composite and metal)<br>3. All abutments (i.e. screws) | | Components | - Paste (A and B)<br>Primer Kit<br>- Bond A/Bond B) and<br>Tokuyama Universal Primer<br>(A/B) | - Bistite II Paste (A and B)<br>- Primer 1 A<br>- Primer 1 B<br>- Primer 2<br>- Metaltite<br>- Tokuso Ceramic Primer A<br>- Tokuso Ceramic Primer B<br>- Air Barrier | - Paste (A and B)<br>- Try In Paste | - Multilink Automix (Base and<br>Catalyst)<br>- Multilink Primer A<br>- Multilink Primer B | - Duo-Link Universal (Base<br>and Catalyst) | | Principle of<br>operation | Dental cement that is cured by<br>chemical and/or photo<br>polymerization reaction.<br>(Dual-cure) | Dental cement that is cured by<br>chemical and/or photo<br>polymerization reaction.<br>(Dual-cure) | Dental cement that is cured by<br>chemical and/or photo<br>polymerization reaction.<br>(Dual-cure) | Dental cement that is cured by<br>chemical and/or photo<br>polymerization reaction.<br>(Dual-cure) | Dental cement that is cured by<br>chemical and/or photo<br>polymerization reaction.<br>(Dual-cure) | 1) This device is presumably marketed with the proprietary name as "CLEARFIL ESTHETIC CEMENT EX." 2) This device is presumably marketed with the proprietary name as "DUO-LINK UNIVERSAL."