CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR

K090931 · W&H Dentalwerk Buermoos GmbH · EKX · Dec 15, 2009 · Dental

Device Facts

• Record ID: K090931
• Device Name: CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR
• Applicant: W&H Dentalwerk Buermoos GmbH
• Product Code: EKX · Dental
• Decision Date: Dec 15, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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 Story

Cordless ENDO-handpiece (EB-300/EB-300 S) consists of a cordless drive unit and a contra-angle attachment (EB-16/EB-16 S) connected via ISO 3964 coupling. Device powered by 3.7 V Li-Ion battery; rechargeable via external station. Operated by dental professionals in clinical settings. User controls include on/off, speed, torque, and auto-reverse/auto-forward modes via buttons on the drive. Device provides mechanical rotation for endodontic files to facilitate root canal preparation. Ergonomic design features reduced weight and size compared to previous iterations to improve usability.

Clinical Evidence

No clinical data were needed for these products; substantial equivalence demonstrated via bench testing.

Technological Characteristics

Modular cordless handpiece; 3.7 V Li-Ion battery; ISO 3964 coupling; mechanical rotary drive; ergonomic housing. No specific ASTM standards cited.

Indications for Use

Indicated for dental patients requiring mechanical and rotary root canal preparation using specialized endodontic files.

Regulatory Classification

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.

Predicate Devices

• Tri Auto ZX, J. Morita USA Inc. (K970339)

Submission Summary (Full Text)

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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 GmbH<br>Ignaz-Glaser-Strasse 53<br>A - 5111 Buermoos<br>Austria<br>Tel.: [phone]<br>Fax: [phone] |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Johann Georg SCHARL |
| Date of Preparation | March 20th, 2009 |
| Device Name | Cordless ENDO-Handpiece "ENTRAN" (W&H)<br>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 of<br>the cordless drive EB-3 H (EB-3 SH) and the special contra-angle<br>attachment EB-16 (EB-16 S), intended for mechanical rotating<br>root canal preparation.<br>The drive is fitted out with a 3.7 V Li-Ion battery, which can be re-<br>charged using the provided charging station. By means of the<br>different buttons on this drive, the user controls the various<br>functions, such as on / off, speed, torque and auto-reverse / auto-<br>forward mode.<br>The drive and the contra-angle attachment are connected via a<br>special coupling, based on ISO 3964.<br>The handpiece's application is intended in dentistry. |
| Intended Use: | Modular electrical system for mechanical preparation of the root<br>canal, using a special root canal instrument (>>ENDO file<<),<br>which is intended by the manufacturer for use in the mechanical<br>and rotary preparation of the root canal. |
| Technological<br>Characteristics | W&H's Handpieces represent a revised and improved version of<br>the predicate device. The main technical characteristics have<br>been retained unchanged.<br>The new products' advantages can be found above all in its<br>usability: less weight and smaller size, better balanced,<br>ergonomically designed. |
| Comparison of the<br>device to the predicate<br>device | The intended use, technological characteristics, performance<br>parameter and material are very similar to the predicate device.<br>The new devices are substantially equivalent to the predicate<br>devices. |
| 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 [phone] or [phone] 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:

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.

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