Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical device for root canal preparation with a motor and controller, and there is no mention of AI, ML, image processing, or any related concepts.

Therapeutic

Yes.
The device is used for the mechanical and rotary preparation of root canals, which is a therapeutic procedure to treat a disease (e.g., pulpitis or necrosis) within the tooth.

Diagnostic

No

The "Intended Use" states that the device is for "mechanical and rotary preparation of root canals," which describes a treatment or surgical procedure, not a diagnostic one. The "Device Description" also details its function in performing "punching, cutting and removing functions," further indicating it performs interventional tasks.

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 is for "endodontic procedures using a root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of root canals." This describes a procedure performed on a patient's body (specifically, within the root canals of a tooth), not on a sample taken from the body.
Device Description: The description details a motor, hand-piece, and controller used to power and control a root canal file. This is a mechanical device used for physical manipulation within the body.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on biological samples.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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

EKX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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.

K092833, K970339, K090931

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

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
1. K970339 J. Morita USA, Inc Tri Auto Zx

1

1. 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
ENDO Motor
Common Name	Cordless
Endodontic
Handpiece	Cordless
Endodontic
Handpiece	cordless
endodontic
treatment
motorized
handpiece
with
root
canal
measurement	Cordless ENDO-
Handpiece
"ENTRAN"
Manufacturer	Saeyang
Microtech	Dentamerica
Inc.	J.Morita USA
Inc.,	W&H
Intended Use	This application
area extends to
endodontic	This
application
area extends to
endodontic	The
TRI
AUTO
ZX
device is a	Modular electrical
system for
mechanical
	procedures
using a root
canal
instrument
which is
intended by the
manufacturer
for use in the
mechanical and
rotary
preparation of
root canals.	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.	cordless
endodontic
treatment
motorized
handpiece
with root
canal
measurement
capability. It
can be used
to enlarge
canals while
monitoring
the position
of the file tip
inside the
canal. It can
be used to
measure the
length of the
canal, and it
can be used
as a low
speed
motorized
handpiece.	preparation of the
root canal, using
a special root
canal
instrument(END
O file), which is
intended by the
manufacturer for
use in the
mechanical and
rotary
preparation of the
root canal.
Allows adjustment of
the motor speed	140~500rpm	125~625rpm	280rpm	300rpm
Allows setting the
torque applied to the
motor in Ncm	0.1-4.0 Ncm	1.0-5.0 Ncm	Low mode or
High mode	0.5~4.0 Ncm
Allows selection of
gear ratios for different
geared E-type
handpieces	4:1, 10:1,
16:1, 20:1	17:1	32:1	16:1
Allows selection of
forward or Auto
reverse drive rotation	YES	YES	YES	YES

2

,

. .

.

3

| Allows reciprocation
drive(forward/reverse
cycling) | Allows the user to
define their own
presets for speed and
torque | Auto Power Off | Product material | Principle of Operation | | by handling of
the controller | by handling of
The controller | by handling of
the controller | by handling of
the controller |
|-----------------------------------------------------------|---------------------------------------------------------------------------|------------------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|----------------------------------|----------------------------------|----------------------------------|----------------------------------|
| YES | YES | YES | -Injection
Molding(ABS)
-Screw cap & o-
ring(silicon)
-machine
work(Kind of
SUS) | 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 | Input voltage(charger) | AC100V~~240V | AC100V~~240
V, 50-60Hz | AC110V or
220V, 50-
60Hz | AC100V~240V,
50-60Hz |
| YES | YES | YES | -Injection
Molding(ABS)
-Screw cap &
o-ring(silicon)
-machine
work(Kind of
SUS) | The motor
turned by the
power
converted into
DC3.6V 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 | Rechageble Battery | Ni_Mh 1.2V2 | Li_ion 3.7V | Ni_Mh 1.2V3 | Li_ion 3.7V |
| YES | YES | YES | -Injection
Molding(ABS)
-Screw cap &
o-ring(silicon)
-machine
work(Kind of
SUS) | The motor
turned by the
power
converted
into DC3.6V
by
controller
delivers
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
speed, torque
and
turning | Motor Voltage | DC2.4V | DC3.6V | DC3.6V | DC2V |
| YES | YES | YES | -Injection
Molding(ABS)
-Screw cap & o-
ring(silicon)
-machine
work(Kind of
SUS) | The motor turned
by the power
converted
into
DC2V
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 | 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)
X 28(H) | 192(L) X
26(W) X
29(H) | 193(L) X
30(W) X
37(H) | 187(L) X 28(W) X
26(H) | | | | | |
| Weight(Handpiece) | 138g | 150g | 130g | 120g | | | | | |
| Demensions(charging
station) | 115(L) X 98(W)
X 60(H) | 105(L) X
85(W) X
59(H) | 123(L) X
88(W) X
55(H) | 160(L) X 95(W) X
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