ENDO A CLASS

{0}------------------------------------------------ ## MARA SAEYANG MICROTECH Image /page/0/Picture/1 description: The image contains two logos. The first logo on the left is a circular logo with a checkmark in the center. The second logo on the right contains the letters "CE" stacked on top of the number "0120". These logos are often found on products to indicate compliance with certain standards or regulations. 100-39. GALSAN-DONG, DALSEO-GU, DAEGU, KOREA, Tel. +82-53-582-9000~2, Fax. +82-53-581-9003 http:// www.saeyang.com, e-mail:marathon@saeyang.com # Section 3: 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. # 510k: K123582 - 1. Submitter's Identification: Saeyang Microtech Co., Ltd. 100-39 Galsan-Dong, Dalseo-Gu, Daegu, Korea Phone: 82-53-582-9000-2 Fax: 82-53-581-9003 Contact - Kim San-ghoon AUG 1 6 2013 Date Summary Prepared: July 12, 2013 #### 2. Name of Device: Trade/Proprietary Name: ENDO a class Classification Name: Handpiece, direct drive, ac-powered ## Class in which Device has been placed: The Dental panel has classified this device as Class I, 21 CFR Part 872.4200, Product Code EKX. #### 3. Predicate Device Information: - 1. K092833 Dentamerica Inc Cordless Endodontic Handpiece - 2. K970339 J. Morita USA, Inc Tri Auto Zx {1}------------------------------------------------ - 3. 090931 W & H Dentalwerk GMBH Cordless ENDO handpiece ENTRAN #### 4. Device Description: The motor turned by the power converted into DC2.4V by controller delivers its turning power to the file through spin to perform punching, cutting and removing functions. The hand-piece can be operated, stopped and set/adjusted on/in its speed, torque and turning direction by handling of the controller. #### 5. Indication for Use: This application area extends to endodontic procedures using a root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of root canals. #### e. Substantial Equivalence: The ENDO a class has similar characteristics and intended use as previously cleared devices. The subject device is substantially equivalent to the predicate devices. | | Device | Predicate 1 | Predicate 2 | Predicate 3 | |---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | | K092833 | K970339 | K090931 | | Device Name | ENDO a Class | Endo-max | Tri Auto ZX | ENTRAN & S5<br>ENDO Motor | | Common Name | Cordless<br>Endodontic<br>Handpiece | Cordless<br>Endodontic<br>Handpiece | cordless<br>endodontic<br>treatment<br>motorized<br>handpiece<br>with<br>root<br>canal<br>measurement | Cordless ENDO-<br>Handpiece<br>"ENTRAN" | | Manufacturer | Saeyang<br>Microtech | Dentamerica<br>Inc. | J.Morita USA<br>Inc., | W&H | | Intended Use | This application<br>area extends to<br>endodontic | This<br>application<br>area extends to<br>endodontic | The<br>TRI<br>AUTO<br>ZX<br>device is a | Modular electrical<br>system for<br>mechanical | | | procedures<br>using a root<br>canal<br>instrument<br>which is<br>intended by the<br>manufacturer<br>for use in the<br>mechanical and<br>rotary<br>preparation of<br>root canals. | to endodontic<br>procedures<br>using a root<br>canal<br>instrument<br>which is<br>intended by<br>the<br>manufacturer<br>for use in the<br>mechanical<br>and rotary<br>preparation of<br>root canals. | cordless<br>endodontic<br>treatment<br>motorized<br>handpiece<br>with root<br>canal<br>measurement<br>capability. It<br>can be used<br>to enlarge<br>canals while<br>monitoring<br>the position<br>of the file tip<br>inside the<br>canal. It can<br>be used to<br>measure the<br>length of the<br>canal, and it<br>can be used<br>as a low<br>speed<br>motorized<br>handpiece. | preparation of the<br>root canal, using<br>a special root<br>canal<br>instrument(END<br>O file), which is<br>intended by the<br>manufacturer for<br>use in the<br>mechanical and<br>rotary<br>preparation of the<br>root canal. | | Allows adjustment of<br>the motor speed | 140~500rpm | 125~625rpm | 280rpm | 300rpm | | Allows setting the<br>torque applied to the<br>motor in Ncm | 0.1-4.0 Ncm | 1.0-5.0 Ncm | Low mode or<br>High mode | 0.5~4.0 Ncm | | Allows selection of<br>gear ratios for different<br>geared E-type<br>handpieces | 4:1, 10:1,<br>16:1, 20:1 | 17:1 | 32:1 | 16:1 | | Allows selection of<br>forward or Auto<br>reverse drive rotation | YES | YES | YES | YES | {2}------------------------------------------------ , . . . {3}------------------------------------------------ | Allows reciprocation<br>drive(forward/reverse<br>cycling) | Allows the user to<br>define their own<br>presets for speed and<br>torque | Auto Power Off | Product material | Principle of Operation | | by handling of<br>the controller | by handling of<br>The controller | by handling of<br>the controller | by handling of<br>the controller | |-----------------------------------------------------------|---------------------------------------------------------------------------|------------------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|----------------------------------|----------------------------------|----------------------------------|----------------------------------| | YES | YES | YES | -Injection<br>Molding(ABS)<br>-Screw cap & o-<br>ring(silicon)<br>-machine<br>work(Kind of<br>SUS) | The motor<br>turned by the<br>power<br>converted into<br>DC2.4V by<br>controller<br>delivers its<br>turning power<br>to the file<br>through spin to<br>perform<br>punching,<br>cutting and<br>removing<br>functions.<br>The hand-piece<br>can be<br>operated,<br>stopped and<br>set/adjusted<br>on/in its speed,<br>torque and<br>turning direction | Input voltage(charger) | AC100V~240V | AC100V~240<br>V, 50-60Hz | AC110V or<br>220V, 50-<br>60Hz | AC100V~240V,<br>50-60Hz | | YES | YES | YES | -Injection<br>Molding(ABS)<br>-Screw cap &<br>o-ring(silicon)<br>-machine<br>work(Kind of<br>SUS) | The motor<br>turned by the<br>power<br>converted into<br>DC3.6V by<br>controller<br>delivers its<br>turning power<br>to the file<br>through spin to<br>perform<br>punching,<br>cutting and<br>removing<br>functions.<br>The hand-<br>piece can be<br>operated,<br>stopped and<br>set/adjusted<br>on/in its<br>speed, torque<br>and turning | Rechageble Battery | Ni_Mh 1.2V*2 | Li_ion 3.7V | Ni_Mh 1.2V*3 | Li_ion 3.7V | | YES | YES | YES | -Injection<br>Molding(ABS)<br>-Screw cap &<br>o-ring(silicon)<br>-machine<br>work(Kind of<br>SUS) | The motor<br>turned by the<br>power<br>converted<br>into DC3.6V<br>by<br>controller<br>delivers<br>turning power<br>to the<br>file<br>through spin<br>to<br>perform<br>punching,<br>cutting and<br>removing<br>functions.<br>The<br>hand-<br>piece can be<br>operated,<br>stopped<br>and<br>set/adjusted<br>on/in<br>speed, torque<br>and<br>turning | Motor Voltage | DC2.4V | DC3.6V | DC3.6V | DC2V | | YES | YES | YES | -Injection<br>Molding(ABS)<br>-Screw cap & o-<br>ring(silicon)<br>-machine<br>work(Kind of<br>SUS) | The motor turned<br>by the power<br>converted<br>into<br>DC2V<br>by<br>controller delivers<br>its turning power<br>to the file through<br>spin to perform<br>punching, cutting<br>and removing<br>functions.<br>The hand-piece<br>can be operated,<br>stopped<br>and<br>set/adjusted on/in<br>its speed, torque<br>and<br>turning<br>direction<br>by<br>handling of the<br>controller | Motor Size | $13 \phi * 31.5(L)$ | $13 \phi * 31.5(L)$ | $13 \phi * 31.5(L)$ | $13 \phi * 31.5(L)$ | | Demensions(Handpiece) | 192(L) X 27(W)<br>X 28(H) | 192(L) X<br>26(W) X<br>29(H) | 193(L) X<br>30(W) X<br>37(H) | 187(L) X 28(W) X<br>26(H) | | | | | | | Weight(Handpiece) | 138g | 150g | 130g | 120g | | | | | | | Demensions(charging<br>station) | 115(L) X 98(W)<br>X 60(H) | 105(L) X<br>85(W) X<br>59(H) | 123(L) X<br>88(W) X<br>55(H) | 160(L) X 95(W) X<br>62(H) | | | | | | . . {4}------------------------------------------------ ### Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows: Testing that was conducted in accordance with IEC 60601-1: 1988 +A1 1991,+A2 1995; ANSI/AAMI/IEC 60601-1-2: 2007; Non-clinical Bench Test performed as following: | Test Standards | Result | |----------------|----------| | ISO3964:1982 | | | ISO7494-1:2004 | Complied | | ISO7785-2:1995 | | | ISO11498:1997 | | Along with the above tests, sterilization validation, software validation, speed accuracy testing, and temperature rise testing were also conducted. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards. {5}------------------------------------------------ #### Discussion of Clinical Tests Performed: 7. No clinical testing was conducted. #### 8. Conclusions: The ENDO a class is substantially equivalent to the predicate in intended use, operation, safety and function. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure embracing a sphere, which is meant to represent the department's mission of protecting the health of all Americans. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 16, 2013 Saevang Microtech Company, Limited C/O Mr. Jigar Shah Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard GREAT NECK NY 11021 Re: K123582 Trade/Device Name: ENDO a Class Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: July 12, 2013 Received: July 18, 2013 Dear Mr. Shah: 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. {7}------------------------------------------------ Page 2 - Mr. Shah 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/ReportalProblem/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, Mary S.Runner -S 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 {8}------------------------------------------------ ### HON SAEYANG MICROTECH Image /page/8/Picture/1 description: The image shows two logos. The logo on the left is a circle with a checkmark inside and the letters "SGS" below. The logo on the right is the letters "CE" stacked on top of the number "0120". 100-39, GALSAN-DONG, DALSEO-GU, DAEGU, KOREA. Tel.+82-53-582-9000~2, Fax.+82-53-581-9003 http:// www.saeyang.com, e-mail:marathon@saeyang.com # Section 2: Indications for Use Page 1 of of 1 510(k) Number (if known): K123582 Device Name: ENDO a class Indications For Use: This application area extends to endodontic procedures using a root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of root canals. Prescription Use × (Per 21 CFR 801 Subpart D) OR 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) Sheena A. Greens 2013.08.16 09:23:32 -04'00' tor M. Susan Runner, DDS, MA (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K123582 2-1