XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM

{0}------------------------------------------------ K123870 #### Xpeed® AnyRidge® Internal Implant System 510(k) Submission # MAR 2 7 2013 ### 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 Phone: 82-53-857-5770 82-53-857-5432 Fax: Contact /US agent: April Lee KoDent, Inc. 325 N. Puente St. Unit B Brea, CA 92821 Phone: 714-525-0114 Fax: 714-525-0116 #### Device Information: Device Name: Xpeed® AnyRidge® Internal Implant System Classification Name: Implant, Endosseous, Root-Form Common Nmae: Endosseous Dental Implant Classification: Class II Product Code: DZE Subsequent Product Code: NHA Regulation number: 21 CFR 872.3640 Date Prepared: 12/12//2012 #### Indication for use The Xpeed® AnyRidge® Internal Implant System is intended to be surgically placed in the maxillaryor mandibular molar areas for the purpose providing prosthetic support for dental restorations(Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading. ### Device Description & Technological Characteristics The Xpeed® AnyRidge® Internal Implant System is especially designed for use in dental implant surgery. It consists of machined titanium, screw-form, root-form endosseous dental implant. The Xpeed® AnyRidge® Internal Implant System contains two types of fixtures, Normal ridge type and low ridge type. This system is made from CP Titanium, Gr.4 and Ti-6AI-4V, ELI and the surface treatment is done with S.L.A (Sand-blasted, Large grit, Acid-etched). The implantsare used to replace missing teeth in various situations ranging from a single missing tooth to the completely edentulous individual. The wide ranges of size are provided to be in conformance with each patient, or to cover up in case of due to deficiency in implant operation. This system has 4.0, 4.4, 4.9, 5.4, 5.9mm diameters for normal ridge and 6.4, 6.9, 7.4, 7.9, 8.4mm diameters for low ridge fixtures. In addition, this system has 6.2, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2mm lengths for normal ridge and 6.4, 7.9, 9.4, 10.9, 12.4, 14.4mm lengths for low ridge fixtures. Fixtures are produced and packaged separately. All included devices in the system are covered by this submission. The purpose of this submission is - the addition of 6.2mm and 6.4mm length implant fixtures, Normal Ridge Type, . FANIHX4507, 5007, and 5507, and Low Ridge Type, FALIHX 6007, 6507, 7007, 7507, and 8007 - the addition of two surgical instrument kits, KARIN 3000 and 30001 and All-in-one case . {1}------------------------------------------------ ### Predicate devices - EZ PLUS Internal Implant System (K070562) � - XpeedAnyRidge Internal Implant System (K122231) . #### Substantial Equivalence Comparison The Xpeed® AnyRidge® Internal Implant System has a substantially equivalent intended use as the identified predicate. The Xpeed® AnyRidge® Internal Implant System is similar in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutments, and they are all constructed of titanium. The subject and predicate device are similar in size and materials. Predicate Device Predicate Device Subject Device K122231 K070562 Not available yet 510(k) Number XpeedAnyRige EZ PLUS XpeedAnyRige Device Name Internal Implant System Internal Implant System Internal Implant System MegaGen Implant Co,. MegaGen Implant Co,. MegaGen Implant Co,. Manufacturer Ltd Ltd Ltd Mandible and Maxilla Mandible and Maxilla Mandible and Maxilla Endosseous Dental Endosseous Dental Endosseous Dental Indications for Use -Implant & Accessories Implant & Accessories Implant & Accessories Xpeed® AnyRidge® Xpeed® AnyRidge® EZ PLUS Internal Implant Internal Implant System, Internal Implant System, abutments and abutments and System, abutments and accessories have been accessories have been accessories have been designed, manufactured designed, manufactured designed, manufactured and tested in compliance and tested in compliance and tested in compliance with FDA's Class II with FDA's Class II with FDA's Class II special controls guidance special controls special controls Design document root-form guidance document guidance document endosseous dental root-form endosseous root-form endosseous implants and endosseous dental implants and dental implants and dental implant abutments endosseous dental endosseous dental implant abutments implant abutments Internal Hex Internal Hex Internal Hex CP Titanium, Gr.4 and Ti-CP Titanium, Gr.4 and CP Titanium, Gr.4 and Material 6Al-4V, ELI Ti-6Al-4V, ELI Ti-6Al-4V, ELI Gamma sterilization Gamma sterilization Gamma sterilization Sterilization Internal type Internal type Internal type: 4.0, 4.4, 4.9, 5.4, 5.9mm 4.0. 4.4. 4.9. 5.4. 5.9mm 3.3.4.0. 5.0mm (For normal ridge) (For normal ridge) Fixture Diameter External type: 6.4, 6.9, 7.4, 7.9, 8.4mm 6.4, 6.9, 7.4, 7.9, 8.4mm 3.3, 4.0, 5.0mm (For low ridge) (For low ridge) Internal type: Internal type Internal type Fixture Height 8.0, 10.0, 11.0, 13.0,15.0, 6.2, 7.7, 9.2, 10.7, 12.2, 6.2, 7.7. 9.2, 10.7, 12.2, There is no difference between the subject and predicate with respect to the indications or technology. {2}------------------------------------------------ #### Xpeed® AnyRidge® Internal Implant System 510(k) Submission | | | 14.20, 17.2mm<br>(For normal ridge)<br>6.4, 7.9, 9.4, 10.9, 12.4,<br>14.4mm<br>(For low ridge) | 14.20, 17.2mm<br>(For normal ridge)<br>6.4, 7.9, 9.4, 10.9, 12.4,<br>14.4mm<br>(For low ridge) | 18.0mm<br>External type:<br>8.0, 10.0, 11.0, 13.0, 15.0,<br>18.0mm | |------------------------------------|-----------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------| | Abutment | Diameters | Ø 4.0 - 10.0mm | Ø 4.0 - 10.0mm | Ø 4.0 - 6.0mm | | | Lengths | 8.4 - 16.4mm | 8.4 - 16.4mm | 9.0 - 17.2mm | | Angulations of Angled<br>abutments | | 15, 25° | 15, 25° | 15, 25° | | Product Code | | DZE, NHA | DZE, NHA | DZE, NHA | | Surface treatment | | SLA | SLA | RBM | ### Non-Clinical Test Data No additional testing was added for this submission. #### 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 concludes that the Xpeed® AnyRidge® Internal Implant system is safe and effective and substantially equivalent to predicate devices as described herein. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. ### 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 March 27, 2013 MegaGenImplant Company, Limited C/O Ms. April Lee KoDent, Incorporated 325 North Puente Street, Unit B BREA CA 92821 Re: K123870 Trade/Device Name: Xpeed® AnyRidge® Internal Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: February 14, 2013 Received: February 25, 2013 Dear Ms. Lee: 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. {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 devicerelated 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm. Sincerely yours, Image /page/4/Picture/7 description: The image shows the name "Kwame O. Ulmer" in bold, black font at the top. Below the name is the acronym "FDA" in a stylized, outlined font. To the left of the acronym is the letter "-S" in a similar font style as the name. Anthony D. Watson, B.S., M.S., M.B.A. for Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indication for Use **510(K) Number (if known):** K123870 Device Name: Xpeed® AnyRidge® Internal Implant System #### Indications for Use: The Xpeed® AnyRidge® Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations(Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading. Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) Over The-Counter Use (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) S. Runner -S -04'00' Division Sign-Off) (Division Sign-Only Division of Ancounters. Dental Devices 510(k) Number