Modular electrical system for mechanical preparation of the root canal, using a special root canal instrument (>>ENDO file <<), which is intended by the manufacturer for use in the mechanical and rotary preparation of the root canal.

Device Description

The cordless ENDO-handpiece EB-300 (EB-300 S) consists of the cordless drive EB-3 H (EB-3 SH) and the special contra-angle attachment EB-16 (EB-16 S), intended for mechanical rotating root canal preparation. The drive is fitted out with a 3.7 V Li-Ion battery, which can be re-charged using the provided charging station. By means of the different buttons on this drive, the user controls the various functions, such as on / off, speed, torque and auto-reverse / auto-forward mode. The drive and the contra-angle attachment are connected via a special coupling, based on ISO 3964. The handpiece's application is intended in dentistry.

AI/ML Overview

The provided 510(k) summary for the W&H Cordless ENDO-Handpieces "ENTRAN" and "S5 ENDO Motor" states that clinical data were not needed and that bench testing results demonstrate substantial equivalence. This indicates that the device's acceptance criteria were based on functional performance and comparison to a predicate device, rather than patient-level outcomes.

Here's a breakdown based on your requested information, with specific notes where information is explicitly not provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Intended Use Equivalence: Modular electrical system for mechanical preparation of the root canal, using a special root canal instrument.	Technological Characteristics: Revised and improved version of the predicate device, retaining main technical characteristics. Advantages found in usability (less weight, smaller size, better balanced, ergonomically designed).
Technological Equivalence: Similar technological characteristics to the predicate device.	The new products' advantages can be found above all in its usability: less weight and smaller size, better balanced, ergonomically designed.
Performance Parameter Equivalence: Similar performance parameters to the predicate device.	The intended use, technological characteristics, performance parameter and material are very similar to the predicate device.
Material Equivalence: Similar materials to the predicate device.	The intended use, technological characteristics, performance parameter and material are very similar to the predicate device.
Substantial Equivalence to Predicate Device: "Tri Auto ZX", J. Morita USA Inc., K970339.	The new devices are substantially equivalent to the predicate devices. Bench testing results demonstrate substantial equivalence.

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

Sample size for test set: Not specified. The document only mentions "Bench testing results."
Data provenance: Not specified. As it's bench testing, it would be laboratory-generated data rather than patient data from a specific country.
Retrospective or prospective: Not applicable for bench testing.

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

Number of experts: Not applicable. Ground truth for most bench tests relies on engineering specifications, physical measurements, and adherence to standards rather than expert clinical consensus.
Qualifications of experts: Not applicable.

4. Adjudication method for the test set

Adjudication method: Not applicable. Bench tests typically involve direct measurement against specifications or comparison to a predicate device's performance under controlled conditions.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

MRMC study: No, an MRMC study was not done. The document explicitly states: "Clinical data were not needed for these new products." This type of study would involve human readers and clinical cases.

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

Standalone study: Yes, implicitly. The "Bench testing results" without clinical data indicate that the device's technical performance was evaluated independently, without requiring human-in-the-loop performance evaluation in a clinical setting for regulatory purposes. The device itself is an "algorithm" only in the sense of its mechanical and electrical function, not in the AI/software sense often associated with "standalone" studies in medical imaging.

7. The type of ground truth used

Type of ground truth: The ground truth for this type of device (dental handpiece) would be based on engineering specifications, performance metrics (e.g., speed, torque, battery life, mechanical integrity), and direct comparison against the predicate device's documented performance. There's no indication of pathology, expert consensus, or outcomes data being used as ground truth for this 510(k).

8. The sample size for the training set

Sample size for training set: Not applicable. This device is a mechanical/electrical handpiece, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Any development data used by the manufacturer would be internal design and testing data.

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

How ground truth was established for training set: Not applicable, as there is no "training set" for this type of device. The ground truth for design and development would be established through engineering principles, material science, and performance targets set by W&H Dentalwerk Buermoos GmbH.

Summary

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K090931

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510(k) Cordless ENDO-Handpieces "ENTRAN" and "S5 ENDO Motor"

Section 5 Page 1 of 1

510(k) SUMMARY

DEC 1 5 2009

Applicant and Owner	W&H Dentalwerk Buermoos GmbHIgnaz-Glaser-Strasse 53A - 5111 BuermoosAustriaTel.: 0043 -6274 / 6236 -297Fax: 0043 -6274 / 6236 -234
Contact Person	Johann Georg SCHARL
Date of Preparation	March 20th, 2009
Device Name	Cordless ENDO-Handpiece "ENTRAN" (W&H)Cordless ENDO-Handpiece "S5 ENDO Motor" (Sendoline)
Classification Name	Handpiece, Direct Drive, Ac-Powered
Regulation Number	21 CFR872.4200
Product Code	EKX
Predicate Devices	"Tri Auto ZX", J. Morita USA Inc., K970339
Device Description	The cordless ENDO-handpiece EB-300 (EB-300 S) consists ofthe cordless drive EB-3 H (EB-3 SH) and the special contra-angleattachment EB-16 (EB-16 S), intended for mechanical rotatingroot canal preparation.The drive is fitted out with a 3.7 V Li-Ion battery, which can be re-charged using the provided charging station. By means of thedifferent buttons on this drive, the user controls the variousfunctions, such as on / off, speed, torque and auto-reverse / auto-forward mode.The drive and the contra-angle attachment are connected via aspecial coupling, based on ISO 3964.The handpiece's application is intended in dentistry.
Intended Use:	Modular electrical system for mechanical preparation of the rootcanal, using a special root canal instrument (>>ENDO file<<),which is intended by the manufacturer for use in the mechanicaland rotary preparation of the root canal.
TechnologicalCharacteristics	W&H's Handpieces represent a revised and improved version ofthe predicate device. The main technical characteristics havebeen retained unchanged.The new products' advantages can be found above all in itsusability: less weight and smaller size, better balanced,ergonomically designed.
Comparison of thedevice to the predicatedevice	The intended use, technological characteristics, performanceparameter and material are very similar to the predicate device.The new devices are substantially equivalent to the predicatedevices.
Performance Testing	Bench testing results demonstrate substantially equivalence
Clinical Testing	Clinical data were not needed for these new products

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Mr. Johann Georg Scharl Regulatory Affairs Manager W & H Dentalwerk Buermoos GmbH Ignaz-Glaser-Strasse 53 A - 5111 Buermoos AUSTRIA

DEC 1 5 2009

Re: K090931

Trade/Device Name: Cordless ENDO Handpiece "ENTRAN" (W&H) Cordless ENDO Handpiece "S5 Endo Motor" (Sendoline) Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: November 25, 2009 Received: November 30, 2009

Dear Mr. Scharl:

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.

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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Page 2- Mr. Scharl

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Ah for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Cordless ENDO-Handpieces "ENTRAN" and "S5 ENDO Motor"

Indications for Use

Device Name:

Cordless ENDO handpiece "ENTRAN" (W&H) Cordless ENDO handpiece "S5 Endo Motor" (Sendoline)

Indication for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over The Counter Use (Part 21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

TSB DDS for Dr. K.P. Muling (Acting)
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090931

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.