T1 LINE DENTAL HANDPIECES

K972436 · Siemens AG · EFB · Sep 22, 1997 · Dental

Device Facts

• Record ID: K972436
• Device Name: T1 LINE DENTAL HANDPIECES
• Applicant: Siemens AG
• Product Code: EFB · Dental
• Decision Date: Sep 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Siemens T1 LINE dental handpieces are intended for use in the dental operatory to prepare dental cavities for restorations such as fillings, and for cleaning teeth.

Device Story

T1 LINE Dental Handpieces are reusable, ergonomically shaped dental instruments used in dental operatories for cavity preparation and teeth cleaning. Devices are AC or air-powered and available with or without fiber optic light systems. Water delivery includes optional one, two, or three spray outlets with a one-way retraction valve to prevent ingress of external air or liquid. Operated by dental professionals, the handpieces facilitate mechanical removal of tooth structure or debris. Sterilization is performed via steam autoclave. The device aids clinicians in restorative and prophylactic procedures, potentially improving procedural efficiency and patient outcomes.

Clinical Evidence

Bench testing only. Compliance with ISO 1797-1 (shanks), ISO 3964 (coupling dimensions), and ISO 7785-2 (straight/geared angle handpieces). Effectiveness validated through 2000 sterilization cycles.

Technological Characteristics

Reusable dental handpiece; AC or air-powered; optional fiber optic light; one, two, or three spray outlets; one-way retraction valve. Materials: metal shanks. Standards: ISO 1797-1, ISO 3964, ISO 7785-2. Sterilization: steam autoclave.

Indications for Use

Indicated for use in dental operatory for cavity preparation for restorations (e.g., fillings) and dental cleaning.

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

• A-DEC/W&H Low Speed Handpieces

Submission Summary (Full Text)

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# 510(k) SUMMARY SIEMENS AG T1 LINE DENTAL HANDPIEC

## DATE PREPARED 1.

June 26, 1997

## SUBMITTER 2.

Siemens AG Medical Technology/Dental Systems Fabrikstrasse 31 64625 Bensheim Germany

#### 3. CONTACT

Mr. Hermann Landgraf 011-49-62-5116-2359

## DEVICE NAME 4.

Proprietary Name: Common/Usual Name: Classification Name:

T1 LINE Dental Handpieces Dental Handpiece Dental Handpiece

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

#### DEVICE CLASSIFICATION 5.

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

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## DEVICE DESCRIPTION AND COMPARISON TO PREDICATE PRODUCTS 6.

The Siemens T1 LINE Dental Handpieces are intended for use in the dental operatory to prepare dental cavities for restorations, such as fillings, and for dental cleanings. The devices can be either AC-powered or air-powered. They are reusable, ergonomically shaped, and are provided both with and without a fiber optic light system. Water delivery has optional one, two, and three spray outlets, and includes a one-way retraction valve to prevent the ingress of external air or liquid when the spray system is not in use. The device can be sterilized by the steam autoclave method.

The Siemens T1 LINE Dental handpieces are similar in design, function, and intended use to other dental handpieces currently in U.S. commercial distribution. Examples of substantially equivalent devices include the A-DEC/W&H Low Speed Handpieces.

#### PERFORMANCE TESTING 7.

The Siemens T1 LINE Dental Handpieces comply with ISO Standard 1797-1 for Dental Rotary Instruments - Shanks made of metal, ISO Standard 3964 for Dental Handpieces - Coupling dimensions, and ISO 7785-2 for Straight and geared angle handpieces. Additional performance testing was conducted on the device to validate the sterilization process and device effectiveness following 2000 sterilization cycles.

6/27/97

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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 features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest the head, body, and tail feathers. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 1997

Diane E. Minear, RAC Senior Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re : K972436 T1 Line Dental Consultants Incorporated Trade Name: Regulatory Class: I Product Code: EFB Dated: June 27, 1997 Received: June 30, 1997

Dear Ms. Minear:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may . be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Minear

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Cluz. L/on
Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and -------Radiological Health

Enclosure -----

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510(k) Number (if known): _ K972 Y36

Device Name: T1 LINE DENTAL HANDPIECES

Indications For Use:

The Siemens T1 LINE dental handpieces are intended for use in the dental operatory to prepare dental cavities for restorations such as fillings, and for cleaning teeth.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Siemens AG--510(k) for T1 Line Dental Handpieces

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