Predicate Devices

K031204, K090931, K031204, K103653, K042822, K113674

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML terms or functionalities.

Therapeutic

Yes
The contra-angle handpieces are used to hold and drive burr instruments for rotary processing in endodontics and for root canal measurement, which are therapeutic dental applications.

Diagnostic

No

Explanation: The contra-angle handpieces are described as being used to "hold and drive burr instruments for the purposes of rotary processing" in dental applications like endodontics and root canal measurement, explicitly stating they are for mechanical processing rather than diagnosis. The devices are tools for treatment or procedures, not for identifying a condition or disease. Even the 'SIRONiTi APEX' which has a 'torque limitation function' to prevent jamming of the file, is a safety feature during a procedure, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical contra-angle handpieces and a lubricant spray, which are hardware components, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The described devices (contra-angle handpieces and lubricant) are used mechanically within the body (specifically, the root canal) for processing and measurement. They are tools used by dental professionals to perform procedures, not to analyze samples taken from the body.
Intended Use: The intended use clearly states "for the purposes of rotary processing" and "for dental applications in endodontics and for root canal measurement." This is a procedural use, not a diagnostic one based on analyzing biological samples.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.

The devices are dental instruments used for treatment and measurement within the root canal, which falls under the category of medical devices, but not specifically in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The contra-angle handpieces are used to hold and drive burr instruments for the purposes of rotary processing. The handpieces are intended for dental applications in endodontics and for root canal measurement and are used by trained dental personnel in dental practices and laboratories. The T1 Spray is intended to be used to clean and lubricate dental handpieces.

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

EGS

Device Description

ENDO 6:1

Endo 6:1 is a contra-angle handpiece which is adapted to dental electric motors or dental air motors with the ISO 3964 interface. It is reusable and it does not have a fiber optic light system.

Extra small head for better access to preparation site ●
Depth measurement in conjunction with an apex locator

T1 LINE ENDO 6 L

The T1 LINE ENDO 6 L contra-angle handpiece is equipped with a fiber optic light system. It is also adapted to dental electric motors or dental air motors with the ISO 3964 interface. It is reusable.

Features of T1 LINE ENDO 6 L:

Extra small head for better access to preparation site
Depth measurement in conjunction with an apex locator

SIRONiTi APEX

The SIRONiTi APEX contra-angle handpiece is adapted to dental electric motors with the ISO 3964 interface. It is reusable.

SIRONiTi APEX is equipped with a torque limitation function. Once a set torque has been reached, a gold plated magnetic coupling prevents jamming of the file in the root canal by retro-rotation.

Features:

. For NiTi files systems
. No jamming of the file in the root canals
Torque level can be easily set ●
For electric motors ●
Extra small head for better access to preparation site ●
Depth measurement in conjunction with an apex locator

T1 Spray

This is the lubricant used for maintenance and cleaning of the drive channels of the handpieces.

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

used by trained dental personnel in dental practices and laboratories.

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)

An evaluation using relevant literature and a critical appraisal of the handpieces by a medical professional have been performed.

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.

K031204, K090931, K031204, K103653, K042822, K113674

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.

K090931, K103653, K042822, and K113674

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 2, 2015

Sirona Dental Systems GmbH c/o Mr. Kofi Aninakwa Sirona Dental Systems, Inc. 30-30 47th Avenue, Suite 500 Long Island City, New York 11101

Re: K150750

Trade/Device Name: Contra-Angle Handpieces: Endo 6:1. Ti Line Endo 6L. SironiTi Apex Regulation Number: 21 CFR 872.4200 Regulation Name: Dental handpiece and accessories Regulatory Class: I Product Code: EGS Dated: May 22, 2015 Received: May 26, 2015

Dear Mr. Aninakwa:

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.

1

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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.

Image /page/1/Picture/8 description: The image contains a signature that reads "Tina Kiang-S". The signature is written in a cursive style, with the first name "Tina" appearing above the last name "Kiang-S". There is a decorative flourish to the left of the name, and a faint watermark in the background.

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

510(k) Number (if known): K150750

Device Name: CONTRA-ANGLE HANDPIECES : Endo 6:1, TI LINE Endo 6 L, SIRONiTi APEX

Indications for Use:

The contra-angle handpieces are used to hold and drive burr instruments for the purposes of rotary processing. The handpieces are intended for dental applications in endodontics and for root canal measurement and are used by trained dental personnel in dental practices and laboratories. The T1 Spray is intended to be used to clean and lubricate dental handpieces.

Prescription Use _X (Part 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 NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

3

510(k) Summary

for

Sirona Dental Systems CONTRA-ANGLE HANDPIECES

1 SPONSOR

Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim Germany

Contact Person: Kofi Aninakwa Telephone: 718-482-2248 Date Prepared: July 1st 2015

DEVICE NAME 2

| Proprietary Names | : Contra-Angle Handpieces: ENDO 6:1 / T1 LINE ENDO 6
L / SIRONiTi Apex.
Cleaner and Lubricant: T1 Spray |
|---------------------|---------------------------------------------------------------------------------------------------------------|
| Common/Usual Name | : Handpiece, Contra- And Right-Angle Attachment, Dental |
| Classification Name | : Dental handpiece and accessories |
| Regulation Number | : 21 CFR 872.4200 |
| Product Code | : EGS |
| Classification | : II |

3 PREDICATE DEVICES

Predicate Devices: Root Canal Treatment:

K090931 – "W&H ENTRAN
K031204 "Morita DENTAPORT ZX ●
K103653 "Dentsply E3 Torque Control Motor ●

Root Canal Measurement Support:

. K031204 – "Morita DENTAPORT ZX
K042822 – "Nouvag TCM Endo V

T1 Spray

K113674 "Spray & Clean Handpiece Cleaner & Lubricant Maxima ● Handpiece Cleaner & Lubricant EZOARE Handpiece Cleaner & Lubricant" (3 trade names carry the same chemical formula)
The primary predicate device is the DENTAPORT ZX (K031204). The reference

4

predicates are K090931, K103653, K042822, and K113674.

4 INTENDED USE

The contra-angle handpieces are used to hold and drive burr instruments for the purposes of rotary processing. The handpieces are intended for dental applications in endodontics and for root canal measurement and are used by trained dental personnel in dental practices and laboratories. The T1 Spray is intended to be used to clean and lubricate dental handpieces.

5 DEVICE DESCRIPTION AND FUNCTION

ENDO 6:1

Endo 6:1 is a contra-angle handpiece which is adapted to dental electric motors or dental air motors with the ISO 3964 interface. It is reusable and it does not have a fiber optic light system.

Extra small head for better access to preparation site ●
Depth measurement in conjunction with an apex locator

T1 LINE ENDO 6 L

The T1 LINE ENDO 6 L contra-angle handpiece is equipped with a fiber optic light system. It is also adapted to dental electric motors or dental air motors with the ISO 3964 interface. It is reusable.

Features of T1 LINE ENDO 6 L:

Extra small head for better access to preparation site
Depth measurement in conjunction with an apex locator

SIRONiTi APEX

The SIRONiTi APEX contra-angle handpiece is adapted to dental electric motors with the ISO 3964 interface. It is reusable.

SIRONiTi APEX is equipped with a torque limitation function. Once a set torque has been reached, a gold plated magnetic coupling prevents jamming of the file in the root canal by retro-rotation.

Features:

. For NiTi files systems
. No jamming of the file in the root canals
Torque level can be easily set ●
For electric motors ●
Extra small head for better access to preparation site ●
Depth measurement in conjunction with an apex locator

T1 Spray

This is the lubricant used for maintenance and cleaning of the drive channels of the handpieces.

5

TECHNOLOGICAL CHARACTERISTICS SUMMARY 6

The overall design of the Sirona contra-angle handpieces is similar to the design of the predicate handpieces in that the predicate devices have similar indications for use and material composition as Sirona's contra-angle handpieces and include similar features, operating parameters, dimensions and functional requirements. The primary predicate device is the DENTAPORT ZX (K031204). The reference predicates are K090931, K103653, K042822, and K113674. Whereas Sirona's T1 LINE ENDO 6L has a light to illuminate the treatment area and is composed of mostly titanium, the predicate devices, Sirona's ENDO 6:1 and SIRONiTi Apex do not have any illumination light and are composed of Stainless Steel*. Morita's Dentaport ZX has a light function for polymerization. SIRONiTi Apex and ENDO 6:1 have the same head heights as the E3 Torque Control Motor and the head height of T1 LINE ENDO 6 L (12.2mm) is similar to the head height of DENTAPORT ZX (12.5mm). Sirona's device Indications for Use align with the indications for use of the primary

predicate.

Sirona's devices are used by trained dental personnel and practices/laboratories for

-Root canal treatment and
-Root canal measurement

while Morita's DENTAPORT ZX and TCM Endo V are used for

-Root canal treatment and
-Root canal measurement

The other predicates have similar indications for use except the ENTRAN EB-300 which has no root canal (Apex) measurement function. Overall, the Sirona's instruments and the predicates have similar intended use. Finally, Sirona's accompanying T1 Spray has nearly identical indications for use as K113674.

*TCM Endo V composition not available.

Below is a comparison of the dental handpieces to the predicate devices:

| Endodontic contra-

angle handpieces	Sirona	Sirona	Sirona
Product Designation	Endo 6:1	SIRONITi Apex	T1 LINE ENDO 6 L
Operating Principle	straight and contra-
angle handpiece	straight and contra-
angle handpiece	straight and contra-
angle handpiece

6

| Indications for Use | The contra-angle
handpieces are used to
hold and drive burr
instruments for the
purposes of rotary
processing. The
handpieces are
intended for dental
applications in
endodontics and for
root canal
measurement and are
used by trained dental
personnel in dental
practices and
laboratories. The T1
Spray is intended to be
used to clean and
lubricate dental
handpieces. | The contra-angle
handpieces are used to
hold and drive burr
instruments for the
purposes of rotary
processing. The
handpieces are
intended for dental
applications in
endodontics and for
root canal
measurement and are
used by trained dental
personnel in dental
practices and
laboratories. The T1
Spray is intended to be
used to clean and
lubricate dental
handpieces. | The contra-angle
handpieces are used to
hold and drive burr
instruments for the
purposes of rotary
processing. The
handpieces are
intended for dental
applications in
endodontics and for
root canal
measurement and are
used by trained dental
personnel in dental
practices and
laboratories. The T1
Spray is intended to be
used to clean and
lubricate dental
handpieces. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Light | No | No | Yes |
| Spray | No | No | No |
| Head height (mm) | 11,4 | 11,4 | 12,2 |
| Head diameter (mm) | 8,7 | 8,7 | 8,7 |
| Weight | 70 g | 98 g | 66 g |
| Material | Stainless Steel | Stainless Steel | Titanium |
| Apex-Function | Apex Locator via
SIROEndo | Apex Locator via
SIROEndo and
Root ZX | Apex Locator via
SIROEndo |

7

Con't
Endodontic
contra-angle
handpieces	Dentsply
(K103653)	W&H
(K090931)	Morita
(K031204)	Nouvag
(K042822)
Product
Designation	E3 Torque Control Motor	ENTRAN EB-300	DENTAPORT ZX	TCM Endo V
Operating Principle	straight and contra-angle
handpiece	straight and contra-angle
handpiece	straight and contra-angle
handpiece	straight and contra-angle
handpiece
Indications for Use	The e3 Torque Control
Motor is a medical device
designed for use by dentists
for use with dental root
canal instruments in
continuous rotation with
torque control or in
reciprocating movement.	Modular electrical
system for mechanical
preparation of the root
canal, using a special
root canal instrument
(>>ENDO file