The Sirona Dental Systems Implant Handpieces are intended for use during endodontic treatment, dental implant surgeries and general dentistry. The Sirona 20:1/80:1 Implant Contra-angle handpieces are indicated for surgery, implantology and general dental applications (drilling, grinding etc.).

Device Description

The Sirona Implant Handpieces are handpieces with transmission ratios of 80:1 and 20:1. They can be driven by torque adjustable electrical motors for surgery treatments and air motors for general dental treatment. The Implant handpieces are attached to their drives via ISO 3964 coupling. A saline irrigation system for surgery treatment is integral to the Implant Handpieces. The head clamp accepts WB instruments complying with ISO 1797-1.

AI/ML Overview

This document describes a 510(k) premarket notification for Sirona Dental Systems Implant Handpieces, which is a dental device, not an AI/ML powered medical device. Therefore, a significant portion of the requested information, particularly regarding acceptance criteria, study details, human reader performance comparisons, and ground truth establishment common in AI/ML device submissions, is not applicable or available in this type of submission.

However, I can extract and state the information that is relevant to the nature of this submission:

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission for a dental handpiece, the acceptance criteria typically revolve around meeting industrial standards for performance, safety, and mechanical integrity, rather than diagnostic accuracy metrics. The "device performance" in this context refers to its ability to function as intended and meet these standards.

Acceptance Criteria	Reported Device Performance
Intended Use Compatibility: Compatibility with endodontic treatment, dental implant surgeries, and general dentistry (drilling, grinding).	The Sirona Implant Handpieces are indicated for these uses.
Transmission Ratios: Availability of 80:1 and 20:1 transmission ratios.	The device is available with 80:1 and 20:1 transmission ratios.
Motor Compatibility: Ability to be driven by torque-adjustable electrical motors for surgery and air motors for general dentistry.	The device can be driven by these types of motors.
ISO 3964 Coupling: Connection to drives via ISO 3964 coupling.	The device is attached via ISO 3964 coupling.
Saline Irrigation System: Integral saline irrigation system for surgery.	The device includes an integral saline irrigation system.
ISO 1797-1 Instrument Compatibility: Head clamp accepts WB instruments complying with ISO 1797-1.	The device accepts instruments complying with ISO 1797-1.
Substantial Equivalence to Predicate Device (W & H WS-75 E/KM Handpieces (K011061)):	The overall design, intended use, principles of operation, and technical features (ISO 1797-1 instrument compatibility, ISO 3964 coupling, saline irrigation system) are similar to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable to this type of device submission. A dental handpiece is a mechanical tool; its "performance" is evaluated through engineering tests, compliance with standards, and comparison to predicate devices, not through studies on a test set of data like an AI/ML diagnostic system. There's no "data" in the sense of medical images or patient records.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. "Ground truth" in the context of an AI/ML diagnostic device refers to the definitively correct diagnosis or finding to which the AI's output is compared. For a dental handpiece, there is no such "ground truth" to establish through expert consensus as it's a tool, not a diagnostic system.

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

This information is not applicable. Adjudication methods are used in studies where multiple experts provide opinions on data to establish a ground truth or resolve discrepancies, typically for diagnostic or prognostic AI/ML systems. This is not relevant for a mechanical medical device like a dental handpiece.

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

This information is not applicable. MRMC studies are specific to evaluating the clinical utility and effectiveness of AI systems in assisting human readers (e.g., radiologists interpreting images). This device is a surgical/procedural tool, not an AI-powered diagnostic aid. Therefore, no such study would be performed for this device.

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

This information is not applicable. This device is a mechanical tool, not an algorithm, so the concept of "standalone performance" for an algorithm is irrelevant.

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

This information is not applicable. As explained in point 3, there is no "ground truth" in the diagnostic sense for a dental handpiece. Its performance is verified against engineering specifications, safety standards, and functional requirements.

8. The sample size for the training set

This information is not applicable. A dental handpiece is a manufactured product; it does not involve machine learning, and therefore there is no "training set."

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

This information is not applicable. As there is no training set (see point 8), there's no ground truth to establish for it.

Summary

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SEP - 6 2005

510(k) Summary for Sirona Dental Systems Implant Handpieces

1. SPONSOR

Sirona Dental Systems GmbH Farbrikstrasse 31 64625 Bensheim Germany

Contact Person:	Fritz Kolle
	Regulatory Manager:

August 26, 2005 Date Prepared:

2. DEVICE NAME

Proprietary Name:	Implant Handpieces
Common/Usual Name:	Dental Handpiece
Classification Name:	Dental Handpiece

PREDICATE DEVICES 3.

W & H WS-75 E/KM Handpieces (K011061)

INTENDED USE 4.

The Sirona Dental Systems Implant Handpieces are intended for use during endodontic treatment, dental implant surgeries and general dentistry. The Sirona indicated for surgery, Contra-angle handpieces are 20:1/80:1 Implant implantology and general dental applications (drilling, grinding etc.).

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DEVICE DESCRIPTION 5.

BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

The overall design of the Sirona Implant Handpieces is similar to the design of the W & H WS-75 E/KM handpiece in that all of these devices allow the use of instruments complying with ISO 1797-1, the connection to motor via the standardized ISO 3964 coupling and offer a similar saline irrigation system.

Based on the comparison of intended use and technical features, Sirona Dental Systems believes that the Sirona Implant Handpieces are substantially equivalent to the predicate W & H Handpiece. The proposed and predicate devices have the same general intended use and principles of operation. The overall design of the proposed and predicate devices is similar.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

Public Health Service

SEP -6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sirona Dental Systems GMBH C/O Mary McNamara-Cullinane Medical Device Consultants, Incorporated 49 Plain St. North Attleboro, Massachusetts 02760-4153

Re: K051661

Trade/Device Name: Implant Handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental handpiece and accessories Regulatory Class: I Product Code: EKX Dated: June 21, 2005 Received: June 22, 2005

Dear Ms. McNamara-Cullinane:

We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Scellon 310(t) profile is substantially equivalent (for the referenced above and have determined the active marketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed previe indications for use stated in the chologic, to regardent date of the Medical Device interstate commerce prior to way 20, 1770, the children with the provisions of Amendments, or to devices that have been results approval of a premaint the Federal Food, Drug, and Cosmene Act (rec) market the device, subject to the general
approval application (PMA). You may, therefore, subject to the general approval application (1 MA). Tou me), not controls provisions of the Act include controls provisions of the Act. "The gentiral of devices, good manufacturing practice, requirements for unnual regginst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (sec above) into controls. Existing major regulations affecting.
(PMA), it may be subject to such additional controls. Title 21, Roys 800 to 89 (PMA), it may be subject to such additional controls. Thisons, Title 21, Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title All, The Fed your device can be found in the Code of Peacha. Acguines in the Federal Register.

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Page 2 -- McNamara-Cullinane

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S issuance of a substantes with other requirements mean that FDA nas made a decemmandin hat your and mistered by other Federal agencies.
of the Act or any Federal statutes and regulations administration to: perstreation of the Act or any rederal statutes and regulations, but not limited to: registration
You must comply with all the Act's requirements and manufacturing progrises You must comply with an the Act 3 Toq (21 CFR Part 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Fall 807), laboling (21 CFR Part 820); and if requirements as set form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

21 CFR 1000-1050.
This letter will allow you to begin marketing your device of your device to a I his letter will anow you to begin maliceming your device of your device to a
premarket notification. The FDA finding of substantial equivalers and thus, and premarket notification. The PDA initing of stockannal vial vice and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), ff you desire specific advice for your device on our our seating on and the regulation please contact the Office of Comphanes at (210) = 10 = 10 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 entified, "Misbranding by reference to premation on your responsibilities under the Act from the may obtain other gelleral mionnation on your i specifical and Consumer Assistance at its toll-free Division of Siman Manataccassel 1, 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, 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): K051661

Device Name: Sirona Dental Systems Implant Handpieces

Indications for Use:

The Sirona Implant 20:1/80:1 Contra-angle handpieces are indicated for surgery, implantology and general dental applications (drilling, grinding etc.).

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)

Sumon Kumar

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:_

Sirona Dental Systems Additional Information – K051661 August 26, 2005

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.