SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES

K983242 · Sirona Dental Systems GmbH · EIA · Dec 11, 1998 · Dental

Device Facts

• Record ID: K983242
• Device Name: SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES
• Applicant: Sirona Dental Systems GmbH
• Product Code: EIA · Dental
• Decision Date: Dec 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The Sirona C8 is an electronically controlled dental operative unit with accessories that are intended to supply power to, and serve as a base for dental devices and accessories. This product is a Dental Operative Unit with accessories that is intended to supply power to, and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is intended for use in the dental clinic environment and used by trained dentists and/or dental technicians and assistants.

Device Story

Sirona C8 is an electronically controlled dental operative unit; serves as a base for dental instruments and accessories. Components include a treatment chair, dentist's element (controls air/water pressure, spray, drive adjustments, and optional cuspidor), assistant's element (controls vacuum/suction), and dental lamp. Operated by dentists, technicians, or assistants in a dental clinic. Provides power and mechanical support for various dental procedures. Enhances clinical workflow by centralizing instrument control and patient positioning.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

AC-powered dental operative unit. Includes treatment chair, dentist's element, assistant's element, and dental lamp. Features electronic control of chair movements and water unit functions. Connectivity is limited to integrated instrument power and control interfaces.

Indications for Use

Indicated for use in dental clinic environments by trained dentists, dental technicians, and assistants to provide power and a base for dental devices and accessories.

Regulatory Classification

Identification

A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.

Predicate Devices

• Pelton & Crane's Spirit S1 (K962071)

Submission Summary (Full Text)

{0}------------------------------------------------

DEC 1 1 1998

510(k) Summary for Sirona C8

K983242

## SPONSOR 1.

Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim, Germany

Contact Person: Walter Schneider Telephone: [phone]

Date Prepared: September 14, 1998

### 2. DEVICE NAME

Proprietary Name: Sirona C8 Common/Usual Name: Dental Operative Unit Classification Name: Dental Operative Unit with Accessories

## PREDICATE DEVICES 3.

Pelton & Crane's Spirit S1 - K962071

#### 4. DEVICE DESCRIPTION

The Sirona C8 Dental Operative Unit and Accessories consist of the following components:

- Treatment Chair
- Dentist's Element which controls the pressure for the air and water, spray and drive adjustments for the instruments which can also be controlled by a foot pedal, and control of the optional Cuspidor feature

{1}------------------------------------------------

- Assistant's Element with Cuspidor, controls automatic and manual air vacuum and suction
- Dental Lamp -

## INTENDED USE 5.

The Sirona C8 is an electronically controlled dental operative unit with accessories that are intended to supply power to, and serve as a base for dental devices and accessories.

# TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The general components, design, characteristics, and mode of operation of the Sirona C8 Dental Operative Unit and Accessories are substantially equivalent to Pelton & Crane's Spirit S1 Dental Systems. Both are AC powered dental operative units with accessories that are intended to supply power to, and serve as a base for dental devices and accessories. Both Dental Systems include a treatment chair, the Dentist's Element, the Assistant's Element and a Dental Light, offer several additional options and electronically control chair movements and water unit functions.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a stylized eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 1998

Sirona Dental Systems GmbH & Company KG C/O Ms. Sheila Hemeon-Heyer Senior Consultant Medical Device Consultant, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K983242 Sirona C8 Dental Operative Unit with Trade Name: Accessories Requlatory Class: I Product Code: EIA Dated: September 14, 1998 Received: September 16, 1998

Dear Ms. Hemeon-Heyer:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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

{3}------------------------------------------------

Page 2 - Ms. Hemeon-Heyer

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral 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/dsma/dsmamain.html".

Sincerely yours,

Patricio Cuevitt/kbr

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number (if known): _

Device Name: _________________________________________________________________________________________________________________________________________________________________ Sirona C8

Indications For Use:

This product is a Dental Operative Unit with accessories that is intended to supply power to, and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is intended for use in the dental clinic environment and used by trained dentists and/or dental technicians and assistants.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hesalol Shepp

Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 98374 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

9/14/98

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Sirona Dental Systems GmbH 510(k) Sirona C8

Page v