T1 CONTROL HIGH SPEED DENTAL HANDPIECE

K965238 · Siemens AG · EFA · Mar 19, 1997 · Dental

Device Facts

• Record ID: K965238
• Device Name: T1 CONTROL HIGH SPEED DENTAL HANDPIECE
• Applicant: Siemens AG
• Product Code: EFA · Dental
• Decision Date: Mar 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Siemens T1 CONTROL high speed dental handpiece is intended for use in the dental operatory to prepare dental cavities for restorations, such as fillings.

Device Story

Air-powered high-speed dental handpiece; used in dental operatory by dentists; prepares cavities for restorations. Features titanium construction; ergonomic design; integrated solid fiber optic light system; three-nozzle water spray system with one-way retraction valves to prevent backflow. Reusable; steam autoclave sterilizable. Provides high-speed rotary motion for dental burs; assists in efficient cavity preparation; improves visibility via integrated lighting; enhances hygiene via retraction valves.

Clinical Evidence

Bench testing only. Compliance with ISO 7785-1 (High Speed Air Turbine Handpieces), ISO 1797 (Dental Rotary Instruments - Shanks), and ISO 9168 (Dental Handpieces - Hose Connectors). Additional validation performed for sterilization process and device effectiveness.

Technological Characteristics

Titanium construction; air-powered turbine; solid fiber optic light system; three-nozzle water spray with one-way retraction valves. Complies with ISO 7785-1, ISO 1797, and ISO 9168. Sterilization: steam autoclave.

Indications for Use

Indicated for use in dental operatories for the preparation of dental cavities for restorations, such as fillings, in patients requiring dental procedures.

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

• Tradition high-speed handpiece (K863677)
• Star Dental 430 series high-speed handpiece (K960719)
• W&H 898 Top Light high-speed handpiece (K944710)

Submission Summary (Full Text)

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K965238
MAR 19 1997

# 510(k) SUMMARY
## SIEMENS AG
### T1 CONTROL HIGH-SPEED DENTAL HANDPIECE

1. DATE PREPARED
December 30, 1996

2. SUBMITTER
Siemens AG
Medical Technology
Dental Systems
Fabrikstrasse 31
64625 Bensheim
Germany

3. CONTACT
Mr. Hermann Landgraf
011-49-62-51-16-2359

4. DEVICE NAME
Proprietary Name: T1 CONTROL High Speed Dental Handpiece
Common/Usual Name: Dental Handpiece
Classification Name: Air-powered Dental Handpiece

Siemens AG 510(k)
T1 Dental Handpiece
12/30/96
Page E-1

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508-643-2237 MED. DEV. CONSULTANTS
574 P02/02 MAR 18 '97 16:59

## 5. DEVICE CLASSIFICATION

Air-powered dental handpieces and accessories have been classified under Section 513 of the Act as Class I devices by the Dental Devices Panel.

Classification Regulation: 21 CFR 872.4200
Product Code: 76 EFB

## 6. DEVICE DESCRIPTION AND COMPARISON TO PREDICATE PRODUCTS

The Siemens T1 CONTROL high speed dental handpiece is intended for use in the dental operatory to prepare dental cavities for restorations, such as fillings. The device is an air-powered, high speed handpiece constructed of titanium. The device is reusable, is ergonomically shaped, and includes a solid fibre optic rod built-in light system. The water delivery geometry includes three spray nozzles in the device head with one-way retraction valves to prevent the ingress of external air or liquid when the spray system is shut down. The device can be sterilized by the steam autoclave method.

The Siemens T1 CONTROL high-speed dental handpiece is similar in design, function, and intended use to other high-speed dental handpieces currently in U.S. commercial distribution. Examples of substantially equivalent devices include the Tradition high-speed handpiece manufactured by Midwest (K863677), the Star Dental 430 series high-speed handpiece manufactured by DEN-TAL-EZ, Inc. (K960719), and the W&H 898 Top Light high-speed handpiece manufactured by A-DEC, Inc. (K944710).

## 7. PERFORMANCE TESTING

The Siemens T1 CONTROL Dental Handpiece complies with ISO Standard 7785-1 for High Speed Air Turbine Handpieces, ISO Standard 1797 for Dental Rotary Instruments - Shanks, and ISO Standard 9168 for Dental Handpieces - Hose Connectors. Additional performance testing was conducted on the device to validate the sterilization process and device effectiveness.

Siemens AG 510(k)
T1 Dental Handpiece
3/18/97
Page E-2