Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical function and control of speed, torque, and direction, with no mention of AI/ML terms or capabilities.

Therapeutic

Yes.
The device is used to perform medical procedures such as drilling and removing carious material for therapeutic purposes in dental procedures.

Diagnostic

No

Explanation: The device description and intended use clearly indicate that this is a surgical/operative tool used for drilling, cutting, and removing material during dental procedures, not for identifying or characterizing a disease or condition. Its functions are mechanical and not focused on diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions a motor, controller, and hand-piece, which are hardware components. The performance studies also include hardware-related testing like temperature rise and sterilization validation.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a device used for dental procedures performed directly on the patient (drilling into the tooth canal, removing carious material from dentin). This is an in vivo application, not an in vitro application.
Device Description: The description details a motor-driven handpiece with a bur for physical manipulation of tooth structure. This aligns with a surgical or procedural device, not a diagnostic test performed on samples outside the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory testing.

IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is purely mechanical and procedural within the patient's mouth.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

EBW

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

tooth canal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Bench Test performed as following:
Test Standards: ISO3964:1982, ISO7494-1:2004, ISO7785-2:1995, ISO11498:1997. Result: Complied.
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.
No clinical testing was conducted.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K111078, K042822, K000547

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
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.(b)
Classification. Class I.

Summary

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
1. K042822 Nouvag Ag's TCM Endo V, Model 1534
1. 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 | 2017500rpm | 30030000rpm | 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 | 199Nmm | 798Nmm | 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