PROSTHODONTIC SCREWDRIVER , MODEL IA-400

K100600 · W&H Dentalwerk Buermoos GmbH · EKX · Jul 9, 2010 · Dental

Device Facts

• Record ID: K100600
• Device Name: PROSTHODONTIC SCREWDRIVER , MODEL IA-400
• Applicant: W&H Dentalwerk Buermoos GmbH
• Product Code: EKX · Dental
• Decision Date: Jul 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

The drive unit is an electrically controlled screwdriver with adjustable torques to tighten and unscrew prosthodontic screws. Consisting of: - Cordless drive unit - Mechanical transmission instrument 80:1

Device Story

Prosthodontic Screwdriver IA-400 is a cordless, battery-powered dental handpiece designed for tightening and unscrewing prosthodontic screws. The device comprises a cordless drive unit (IA-40H), a mechanical contra-angle attachment (IA-80, 80:1 ratio), and a finger-operated keypad. The drive unit is powered by a 3.7 V Li-Ion battery, rechargeable via a dedicated station. The user controls operational parameters—including ON/OFF, rotation direction (forward/reverse), and torque settings—via buttons on the drive unit, while the keypad initiates or stops rotation. The device is used in a dental clinical setting by a dentist or dental professional. By providing adjustable torque and ergonomic, cordless operation, the device facilitates precise screw manipulation, potentially improving usability and flexibility compared to traditional manual or corded tools.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through bench testing and verification of conformance to applicable technical standards.

Technological Characteristics

Cordless, battery-powered (3.7 V Li-Ion) dental handpiece. Features a mechanical transmission instrument (80:1 ratio) connected via ISO 3964 coupling. Includes adjustable torque control and finger-switch operation. Designed for dental use. Verification performed via bench testing.

Indications for Use

Indicated for use by dental professionals to tighten and unscrew prosthodontic screws using an electrically controlled screwdriver with adjustable torque settings.

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

• implantMED SI-915 (K052741)
• WS-75 E/KM (K052741)
• Cordless Endo Handpc. ENTRAN (K090931)

Submission Summary (Full Text)

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K100600

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વર્ષના વિદ્યાર્થો વિભાગના પાકની ખેત

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Section 5
Page 1 of 2

JUL·- 9 2010

## 510(k) SUMMARY

| 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 Submission | March 1st, 2010 |
| Device Name | Prosthodontic Screwdriver IA-400 |
| Classification Name | Handpiece, Direct Drive, Ac-Powered |
| Regulation Number | 21 CFR872.4200 |
| Product Code | EKX |
| Predicate Devices | - "implantMED SI-915", cleared by W&H Dentalwerk Buermoos under K052741<br>+ "WS-75 E/KM", cleared by W&H Dentalwerk Buermoos as an accessory to the<br>"implantMED SI-915" in file K052741<br>- Cordless Endo Handpc. "ENTRAN", W&H Dentalwerk Buermoos, K090931 |
| Device Description | The cordless Prosthodontic Screwdriver IA-400 consists of the<br>cordless drive IA-40H, the contra-angle attachment IA-80 and a<br>key pad (finger switch).<br><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.<br><br>The drive and the contra-angle attachment are connected via a<br>special coupling, based on ISO 3964.<br><br>By means of the different buttons on the drive the user controls<br>the various settings, such as ON, forward/reverse and the torque.<br>The attached key pad (finger switch) allows starting and stopping<br>the screwdriver's rotation.<br><br>The handpiece's application is intended in dentistry. |
| Intended Use: | The drive unit is an electrically controlled screwdriver with<br>adjustable torques to tighten and unscrew prosthodontic screws.<br><br>Consisting of:<br>- Cordless drive unit<br>- Mechanical transmission instrument 80:1 |

July 8th, 2010

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| Image: W&H logo | 510(k)<br>Prosthodontic Screwdriver IA-400 | Section 5<br>Page 2 of 2 |
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| Technological<br>Characteristics | W&H's "Prosthodontic Screwdriver IA-400" represents a device<br>combining the technical principle of the cordless ENDO-<br>Handpiece "ENTRAN" (510(k) no. K090931) with a special field of<br>applicability of W&H's drive unit "implantMED SI-915", provided<br>with the contra-angle handpiece attachment type WS-75 E/KM<br>(both cleared for market under 510(k) K052741). |
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| Comparison of the<br>device to the predicate<br>device | The advantage of the new product is based, above all, on the fact<br>that the "Prosthodontic Screwdriver IA-400" was designed for a<br>detail of the "implantMED's" applicability. So it offers advantages<br>with respect to usability and flexibility: cordless, less weight,<br>smaller size, better balanced, ergonomically designed. |
| | The intended purpose of the predicate device "implantMED"<br>covers the new device's intended use; "implantMED's"<br>performance parameters are very similar in this respect to the<br>new device's ones.<br>The technological characteristics and materials, on the other<br>hand, are very similar to those of the predicate device "ENTRAN". |
| | With respect to the functions considered as intended use, the new<br>device can be judged to be substantially equivalent to the<br>predicate devices. |
| Performance Testing | W&H's Prosthodontic Screwdriver IA-400 was developed and is<br>produced under consideration of all applicable technical<br>standards and quality management directives. |
| | The product's conformance with the applicable technical<br>standards was verified in the course of type testing. Bench testing<br>results demonstrated substantially equivalence. Perfect<br>functionality and accuracy of all serial devices are controlled in the<br>final step of production. |
| | Corresponding certificates and the application of the CE-mark<br>give evidence of the product's high quality. |
| Clinical Testing | Clinical data were not needed for this new product. |

July 8th, 2010

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

Mr. Johann G. Scharl Regulatory Affairs Manager W & H Dentalwerk Buermoos GMBH 53 Ignaz-Glaser- Strasse Buermoos Austria 5111

JUL - 9 2010

Re: K100600

Trade/Device Name: Prosthodontic Screwdriver IA-400 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: June 25, 2010 Received: June 25, 2010

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. 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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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.goy/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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

h 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

Enclosure

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[W&H]
510(k)
Prosthodontic Screwdriver IA-400
Section 4
Page 1 of 1
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`K100600`

Indications for Use

| <strong>Labels</strong> | <strong>Values</strong> |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number: | not known yet |
| Device Name: | Prosthodontic Screwdriver IA-400 |
| Indication for Use: | The drive unit is an electrically controlled screwdriver with adjustable torques to tighten and unscrew prosthodontic screws. Consisting of: - Cordless drive unit - Mechanical transmission instrument 80:1 |

| <strong>Labels</strong> | <strong>Values</strong> |
|--------------------------------------------------|-------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
| Over The Counter Use (Part 21 CFR 807 Subpart C) | |

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muluy for MSR
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K100600

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