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.

Device Description

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.
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.
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.
T1 Spray is the lubricant used for maintenance and cleaning of the drive channels of the handpieces.

AI/ML Overview

The provided text is a 510(k) Summary for dental handpieces. This document focuses on demonstrating substantial equivalence to predicate devices based on design, function, and performance standards, rather than proving a device meets specific acceptance criteria based on clinical study performance of an AI-powered device.

Therefore, many of the requested categories for AI/clinical study performance (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established) are not applicable to the information contained in this type of submission.

The document does not describe the acceptance criteria and a study proving the device meets those criteria in the context of an AI-powered medical device and its performance against a specific clinical outcome. Instead, it demonstrates compliance with recognized performance standards for dental handpieces.

However, I can extract the relevant information regarding the performance standards and a general conclusion of equivalency:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Performance Standard)	Reported Device Performance (Compliance)
ISO 14457:2012-09-15 Dentistry Handpieces And Motors	Complies
ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management system	Complies
ISO 7405:2008-12-15 Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry [Including: Amendment 1 (2013)]	Complies
ISO 14971:2007-03-01 Medical Devices - Application Of Risk Management To Medical Devices	Complies
ISO 15223-1:2012-07-01 Medical Devices - Symbols To Be Used With Medical Device Labels, Labeling, And Information To Be Supplied - Part 1: General Requirements	Complies
AAMI ANSI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities	Complies
DIN EN ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity	Complies
ISO 10993-10:2010-08-01 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization	Complies
EN ISO 13485:2003 Medical devices Quality management systems -- Requirements for regulatory purposes	Complies
DIN EN ISO 17664:2004 – Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices	Complies
DIN EN ISO 21531:2009 – Dentistry -- Graphical symbols for dental instruments	Complies
ISO 3964:1982 - Dental handpieces – Coupling dimensions	Complies

2. Sample size used for the test set and the data provenance:

Not applicable for a 510(k) submission of this type of device. The compliance is based on meeting engineering and biocompatibility standards, not on clinical performance evaluations with a specific test set of patients/data. The "study" mentioned is conformity to existing standards, which implicitly involves testing the device against those standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth in the context of clinical performance is not established here. The document mentions "An evaluation using relevant literature and a critical appraisal of the handpieces by a medical professional have been performed," but this is for overall assessment, not for establishing ground truth on a specific test set for an AI algorithm.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is not an AI-powered device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No. This is not an AI-powered device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. For this type of device, "ground truth" relates to the device successfully meeting the specifications outlined in the various ISO/DIN/AAMI standards (e.g., sterilization effectiveness, biocompatibility, mechanical performance as per ISO 14457).

8. The sample size for the training set:

Not applicable. This is not an AI-powered device.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI-powered device.

Summary of the study that proves the device meets the acceptance criteria (from the text):

The device's performance is demonstrated through its compliance with a list of recognized national and international performance standards (listed in the table above). These standards cover aspects such as mechanical performance, biocompatibility, risk management, sterilization, labeling symbols, and quality management systems. The document states: "The Sirona Dental System T1 LINE Endo 6 L, ENDO 6:1 and SIRONiTi Apex contra-angle handpieces comply with the following performance standards." Additionally, "An evaluation using relevant literature and a critical appraisal of the handpieces by a medical professional have been performed." This implies that testing and evaluation against these standards were conducted to ensure the devices meet the specified requirements for safety and performance. The conclusion drawn is that "Based on a comparison of intended use, indications, principal of operations, features and technical data, the Sirona Dental Systems T1 LINE ENDO 6 L, ENDO 6:1 and SIRONiTi APEX are similar in design and function to the Predicate Devices. Therefore, the subject device is substantially equivalent to the predicate device."

Summary

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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.

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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

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510(k) Number (if known): K150750

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

Indications for Use:

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)

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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 6L / 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

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predicates are K090931, K103653, K042822, and K113674.

4 INTENDED USE

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.

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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

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Indications for Use	The contra-anglehandpieces are used tohold and drive burrinstruments for thepurposes of rotaryprocessing. Thehandpieces areintended for dentalapplications inendodontics and forroot canalmeasurement and areused by trained dentalpersonnel in dentalpractices andlaboratories. The T1Spray is intended to beused to clean andlubricate dentalhandpieces.	The contra-anglehandpieces are used tohold and drive burrinstruments for thepurposes of rotaryprocessing. Thehandpieces areintended for dentalapplications inendodontics and forroot canalmeasurement and areused by trained dentalpersonnel in dentalpractices andlaboratories. The T1Spray is intended to beused to clean andlubricate dentalhandpieces.	The contra-anglehandpieces are used tohold and drive burrinstruments for thepurposes of rotaryprocessing. Thehandpieces areintended for dentalapplications inendodontics and forroot canalmeasurement and areused by trained dentalpersonnel in dentalpractices andlaboratories. The T1Spray is intended to beused to clean andlubricate dentalhandpieces.
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 viaSIROEndo	Apex Locator viaSIROEndo andRoot ZX	Apex Locator viaSIROEndo

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Con't
Endodonticcontra-anglehandpieces	Dentsply(K103653)	W&H(K090931)	Morita(K031204)	Nouvag(K042822)
ProductDesignation	E3 Torque Control Motor	ENTRAN EB-300	DENTAPORT ZX	TCM Endo V
Operating Principle	straight and contra-anglehandpiece	straight and contra-anglehandpiece	straight and contra-anglehandpiece	straight and contra-anglehandpiece
Indications for Use	The e3 Torque ControlMotor is a medical devicedesigned for use by dentistsfor use with dental rootcanal instruments incontinuous rotation withtorque control or inreciprocating movement.	Modular electricalsystem for mechanicalpreparation of the rootcanal, using a specialroot canal instrument(>>ENDO file<<), whichis intended by themanufacturer for use inthe mechanical androtary preparation ofthe root canal.	The DENTAPORT ZX is adental root canalmeasurement andtreatment device that canmeasure the length of theroot canal and enlarge thecanal while monitoring theposition of the file tip insidethe canal.	The TCM Endo V is adental root canalmeasurement andtreatment device that canmeasure the length of theroot canal and enlarge thecanal while monitoringthe position of the file tipinside the canal.
Light	No	No	Yes	No
Spray	No	No	Yes	No
Head height (mm)	11,4	Miniature Head	12,5	Miniature Head
Head diameter(mm)	8,7	Miniature Head	n/a	Miniature Head
Weight	70 g	85	70 g	n.a
Material	Stainless Steel	Stainless Steel	Stainless Steel	n.a
Apex-Function	Apex Locator via DentalTreatment Unit orSIROEndo Pocket	No	Yes	Yes

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7 NON CLINICAL TESTING

The Sirona Dental System T1 LINE Endo 6 L, ENDO 6:1 and SIRONiTi Apex contraangle handpieces comply with the following performance standards:

ISO 14457 First Edition 2012-09-15 Dentistry Handpieces And Motors ●
. ISO 10993-1:2009Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management system
ISO 7405 Second Edition 2008-12-15 Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry [Including: Amendment 1 (2013)]
ISO 14971 Second Edition 2007-03-01 Medical Devices - Application Of Risk Management To Medical Devices
ISO 15223-1 Second Edition 2012-07-01 Medical Devices - Symbols To Be Used With Medical Device Labels, Labeling, And Information To Be Supplied -Part 1: General Requirements
. AAMI ANSI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities
DIN EN ISO 10993-5:2009 Biological evaluation of medical devices Part 5: ● Tests for in vitro cytotoxicity
ISO 10993-10 Third Edition 2010-08-01 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
EN ISO 13485:2003 Medical devices Quality management systems --● Requirements for regulatory purposes
DIN EN ISO 17664:2004 – Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices
. DIN EN ISO 21531:2009 – Dentistry -- Graphical symbols for dental instruments
. ISO 3964 : 1982 - Dental handpieces – Coupling dimensions

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

8 CONCLUSION

Based on a comparison of intended use, indications, principal of operations, features and technical data, the Sirona Dental Systems T1 LINE ENDO 6 L, ENDO 6:1 and SIRONiTi APEX are similar in design and function to the Predicate Devices. Therefore, the subject device is substantially equivalent to the predicate device.

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.