Who is the manufacturer of ENDO E CLASS?

Saeyang Microtech Co., Ltd. filed the 510(k) submission for ENDO E CLASS (K123608).

What is the FDA product code for ENDO E CLASS?

EBW. It is classified under 21 CFR 872.4200 as a Class 1 device in the Dental panel.

What is the regulatory pathway for ENDO E CLASS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ENDO E CLASS?

Aseptico, Inc's AEU-26L Electronic Endodontic System (K111078); Nouvag Ag's TCM Endo V, Model 1534 (K042822); A.T.R.'S TECNIKA (K000547).

Who can help prepare an FDA 510(k) submission like ENDO E CLASS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ENDO E CLASS

K123608 · Saeyang Microtech Co., Ltd. · EBW · Aug 16, 2013 · Dental

Device Facts

Record ID	K123608
Device Name	ENDO E CLASS
Applicant	Saeyang Microtech Co., Ltd.
Product Code	EBW · Dental
Decision Date	Aug 16, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4200
Device Class	Class 1
Attributes	Therapeutic

Intended Use

For use in a wide range of dental procedures including; endodontic surgeries, such as drilling in to the tooth canal, and general dentistry, such as removing carious material from the dentin.

Device Story

ENDO e class is an electric dental handpiece system. Controller converts power to DC24V to drive an E-type micromotor; motor delivers rotational power to a bur or file for punching, cutting, and removing dental material. Operated by a clinician in a dental setting; speed, torque, and rotation direction are set/adjusted via the controller and foot switch. System allows for forward/reverse cycling and auto-stop functionality. Provides clinicians with precise control over drilling and removal tasks during endodontic and general dental procedures, facilitating efficient treatment of tooth canals and dentin.

Clinical Evidence

No clinical testing was conducted. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (IEC 60601-1, ANSI/AAMI/IEC 60601-1-2), performance standards (ISO 3964, ISO 7494-1, ISO 7785-2, ISO 11498), sterilization validation, software validation, speed accuracy, and temperature rise testing.

Technological Characteristics

System includes control unit, E-type micromotor, handpiece, and foot switch. Materials: ABS (injection molding), silicon (screw cap/o-ring), and stainless steel (machine work). Energy source: Electric (DC24V). Connectivity: Wired foot pedal control. Standards: IEC 60601-1, ISO 3964, ISO 7494-1, ISO 7785-2, ISO 11498. Software: Embedded control for motor speed, torque, and rotation direction.

Indications for Use

Indicated for dental patients requiring endodontic surgeries (e.g., tooth canal drilling) and general dentistry procedures (e.g., carious material removal from dentin).

Regulatory Classification

Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

Predicate Devices

Aseptico, Inc's AEU-26L Electronic Endodontic System (K111078)
Nouvag Ag's TCM Endo V, Model 1534 (K042822)
A.T.R.'S TECNIKA (K000547)

Related Devices

K123582 — ENDO A CLASS · Saeyang Microtech Co., Ltd. · Aug 16, 2013
K111616 — E-CUBE · Saeshin Precision Co., Ltd. · Aug 19, 2011
K032572 — A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT · A-Dec, Inc. · Dec 3, 2003
K090937 — E-STATIS 40 SYSTEM · Scican , Ltd. · Jul 24, 2009
K964863 — MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN · Bell Intl., Inc. · Feb 28, 1997

Submission Summary (Full Text)

{0}------------------------------------------------ ### MARAT SAEYANG MICROTECH Image /page/0/Picture/1 description: The image contains two different symbols. The symbol on the left is a circle with a checkmark inside, surrounded by some text. The symbol on the right is the CE marking followed by the number 0120 below it. 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. 510(k): 123608 #### 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 e class ## Classification Name: Controller, Foot, Handpiece And Cord ## Class in which Device has been placed: The Dental panel has classified this device as Class I, 21 CFR Part 872.4200, Product Code EBW. #### Predicate Device Information: 3. - 1. K111078 Aseptico, Inc's AEU-26L Electronic Endodontic System - 2. K042822 Nouvag Ag's TCM Endo V, Model 1534 - 3. K000547 A.T.R.'S TECNIKA {1}------------------------------------------------ #### 4. Device Description: The motor turned by the power converted into DC24V by controller delivers its turning power to the bur 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: For use in a wide range of dental procedures including; endodontic surgeries, such as drilling in to the tooth canal, and general dentistry, such as removing carious material from the dentin. #### 6. Substantial Equivalence: The ENDO e class has similar characteristics and intended use as previously cleared devices. The subject device is substantially equivalent to the predicate devices. | | Subject Device | Predicate 1 | Predicate 2 | Predicate 3 | | through spin to perform | through spin to perform | spin to perform punching. cutting and removing functions. | set/adjusted on/in its speed, torque and turning direction by handling of the controller | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | 510(k) Number | K123608 | K111078 | K000547 | K042822 | | 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 | 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 | The hand-piece can be operated, stopped and set/adjusted on/in its torque and turning direction by handling of the controller | | | Device Name | ENDO E Class | AEU-26L | ATR TECNIKA | TCM ENDO V | Allows adjustment of the motor speed | 20~17500rpm | 300~30000rpm | 1600~12800rpm | 1200~16000rpm | | Common Name | Dental Handpiece and accessories | Dental Handpiece and accessories | Dental Handpiece and Accessories | Endodontic Device with Apex locator | Torque setting range applied to the motor in Nmm | 1~99Nmm | 7~98Nmm | 1~99Nmm | 2~50Nmm | | Manufacturer | Saeyang Microtech | ASEPTICO | Advanced Technology Research | NOUVAG AG | Allows reciproating drive (forward/reverse cycling) | Yes | Yes | Yes | Yes | | Intended Use | For use in a wide range of dental procedures including: endodontic surgeries, such as drilling in to the | For use in a wide range of dental procedures including: endodontic surgeries, such as drilling in to the tooth | The ATR Tecnika is intended for dental drilling and tightening of various type of screw in dental implantation | The TCM Endo V is a dental root canal measurement and treatment device that can measure the length of the root canal and enlarge the root canal while monitoring the position of the file tip inside the | Allows setting the torque applied to the motor in gram/cm | Units not in gram/cm. Torque is configurable from 1 to 99 | Yes Torque accuracy | Units not in gram/cm. Torque is configurable from 1 to 99 | Yes | | | tooth canal, and general dentistry, such as removing carious material from the dentin. | canal, and general dentistry, such as removing carious material from the dentin. | and in microsurgery | canal. | Allows selection of gear ratios for different geared E-type | 1:1, 4:1, 6:1, 8:1, 10:1, 16:1, 20:1, 64:1 | 1:5, 1:1, 8:1, 16:1 | 15:1. 16:1, 18:1, 20:1 | 8:1 | | Micromotor drive | electric Micromotor drive | electric Micromotor drive | electric Micromotor drive | electric Micromotor drive | | | | | | | Package contents | Control Unit. E-type Motor & Motor Cord, E-type Handpiece, foot switch, Handpiece stand, Power Cord, * Autoclaving Plugs, Manual | Electronic Control Console, E- type Micromotor & Motor Cord, E- type Handpiece, foot switch, Handpiece stand, Power Cord, Manual | control unit, foot-pedal, E- type micromotor, handpiece stand, autoclave plug, power cord, Manual. | Control Unit. Endo micro- motor, foot switch, Handpiece stand. Lip connector cable. Manual | | | | | | | Product material | -Injection Molding(ABS) -Screw cap & o-ring(silicon) -machine work(Kind of SUS) | -Injection Molding(ABS) -Screw cap & o-ring(silicon) -machine work(Kind of SUS) | -Injection Molding(ABS) -Screw cap & o-ring(silicon) -machine work(Kind of SUS) | -Injection Molding(ABS) -Screw cap & o- ring(silicon) -machine work(Kind of SUS) | | | | | | | Principle of Operation | The motor turned by the power converted into DC Voltage by controller delivers its turning power to the file | The motor turned by the power converted into DC Voltage by controller delivers its turning power to the file | The motor turned by the power converted into DC Voltage by controller delivers its turning power to the file through | The motor turned by the power converted into DC Voltage 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 | | | | | | {2}------------------------------------------------ . {3}------------------------------------------------ : {4}------------------------------------------------ | handpieces | | | | | |----------------------------------------------------------------------------------------------|----------------------------------------------------|-----------------------------------|-----------------------------------|--------------------------------| | Allows selection of forward or Auto reverse drive rotation | YES | YES | YES | YES | | Allows selection of Auto stop | YES | NO | NO | YES | | Allows use of a foot pedal control to operate the attached handpiece motor | YES electronic foot control | YES electronic foot control | YES electronic foot control | YES electronic foot control | | Allows the user to define their own presets for speed and torque | YES | YES | YES | YES | | Allows programmable doctor's choice | YES | YES | YES | NO | | Input voltage(charger) | AC100V~120V, 50/60Hz AC220V~240v, 50/60Hz | AC100V~240V, 50-60Hz | AC110V or AC220V. 50/60Hz | 100V~/115V~/230V~,50-60Hz | | handpiece Coupling type | E-type | E-type | E-type | NOUVAG AG only | ### 7. Discussion of Non-Clinical Tests Performed for Determination of 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: {5}------------------------------------------------ | 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. #### 8. Discussion of Clinical Tests Performed: No clinical testing was conducted. #### 9. Conclusions: The ENDO e class is substantially equivalent to the predicate devices 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 a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 16, 2013 Saeyang Microtech Company, Limited C/O Mr. Jigar Shah Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard GREAT NECK NY 11021 Re: K123608 Trade/Device Name: ENDO e class Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW 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. Ilsting 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/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 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, 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}------------------------------------------------ # SAEYANG MICROTECH Image /page/8/Picture/1 description: The image shows two certification logos. The logo on the left is a circle with a checkmark inside and the letters "STS" below it. The logo on the right is the CE marking followed by the number "0120". These logos are often found on products to indicate that they meet certain safety and quality standards. 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 1 510(k) Number (if known): 123608 Device Name: ENDO e class Indications For Use: For use in a wide range of dental procedures including; endodontic surgeries, such as drilling in to the tooth canal, and general dentistry, such as removing carious material from the dentin. 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. Green - S 2013.08.16 13:06:48-04.00 for M. Susan Runner, DDS, MA ivision Sign-Off) vision of Anesthesiology, General Hospital tection Control, Dental Devices 10(k) Number: K 123(008 2-1