I-GEN

{0}------------------------------------------------ #### 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. #### Submitter: Dong Guk Ha MegaGenImplant Co., Ltd. 472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si Gyeongbuk, South Korea Email: kodentinc@gmail.com Phone: 82-53-857-5770 Fax: 82-53-857-5432 ### Device Information: Device Name: i-Gen Common Name: Plate, Bone Regulation number: 21 CFR 872.4760 Classification Name: Bone Plate Product Code: JEY Classification: Class II Date Prepared: 8/23/2013 Contact /US agent: April Lee KoDent, Inc. 325 N. Puente St. Unit B Brea, CA 92821 Email: kodentinc@gmail.com Phone: 714-525-0114 Fax: 714-525-0116 SEP 25 2013 #### General Description i-Gen is 3D Pre-Formed titanium membrane is intended for stabilizing and supporting bone graft in dento-alveolar bony defect sites. The devices are made of CP Ti Grade 2 (ASTM F67) and supplied in various sizes and shapes, non-coated, sterile, for single-use and disposable. i-Gen can be chosen according to the size and shape of bone defect. It has seven kind of buccal widths (9, 10, 11, 13, 15, 17, 22 mm) and four kind of buccal lengths (11, 15, 16, 17.5 mm). It has also four types (A B, C, D type), and three sizes (Small, Regular, Wide) for each type according to the location of the part used. #### Indication for use i-Gen is a titanium bone plate device intended to stabilization and support bone grafts in dento-alveolar bony defect sites. #### Predicate devices neobiotech Neo Titanium mesh (K111761) {1}------------------------------------------------ 510(k) Number Device Name Manufacturer Indications for Use grafts in dento- | Subject Device | Predicate Device | |------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | Not available yet | K111761 | | i-Gen | Neo Titanium mesh (CTi-mem) | | Megagen Implant Co., Ltd. | neobiotech Co., Ltd. | | To stabilization and support bone<br>grafts in dento-alveolar bony defect<br>sites | To stabilize and support of bone<br>graft in dento-alveolar bony defect<br>sites | | Design | Image: Design 1 | Image: Design 2 | |---------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------| | Material | CP Titanium Grade 2 (ASTM F67) | CP Titanium Grade 2 (ASTM F67) | | Sterilization | Sterile | Sterile | | Width | 9, 10, 11, 13, 15, 17, 22 mm | 8, 9, 10, 12 mm | | Length | 11, 15, 16, 17.5 mm | 6, 8, 10, 15, 20 mm | | Product Code | JEY | JEY | | Shelf life | 5 years | - | | SE | i-Gen has same device characteristics, material, and intended use as the<br>predicate device, such as the Neo Titanium mesh. | | ## Substantial Equivalence Comparison i-Gen has a substantially equivalent in intended use and device characteristics as the predicate device, such as the Neo Titanium mesh. The subject and predicate device are similar in size and materials. When compared with predicate device, no new questions of safety or effectiveness have been raised for i-Gen. {2}------------------------------------------------ # Non-Clinical Test Data The biocompatibility testing such as cytotoxicity in accordance with ISO 10993-5, sterilization validation, and shelf life validation were performed on this subject device. ### Conclusions In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Megagen Co., Ltd. concludes that i-Gen is substantially equivalent to predicate devices as described herein. し {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 25, 2013 Megagen Implant Company, Limited C/O Ms. April Lee Consultant Kodent 325 North Puente Street Unit B BREA CA 92821 Re: K131289 Trade/Device Name: i-Gen Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: August 23, 2013 Received: August 27, 2013 ### Dear Ms. Lec: 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 cnacunent 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 I he general connoto 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. {4}------------------------------------------------ Page 2 - Ms. Lee 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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 yours, Richard C. Chapman for Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation · Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ 510(k) Submission # Indication for Use 510(K) Number (if known): _ < 131289 Device Name: i-Gen Indications for Use: i-Gen is a titanium bone plate device intended to stabilization and support bone grafts in dentoalveolar bony defect sites. Prescription Use AND/OR OverThe-Counter Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) # (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Andrew I. Steen -S 2013.09.24 14:43:14-04-00 (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: 3/2 89 l