(86 days)
Not Found
No
The summary describes a standard dental operative unit with mechanical and electrical controls, with no mention of AI or ML features, image processing, or data analysis capabilities typically associated with AI/ML in medical devices.
No.
The device is a dental operative unit, providing power and serving as a base for other dental devices, rather than directly diagnosing, treating, or preventing a disease or condition itself.
No
The device is described as a Dental Operative Unit that supplies power and serves as a base for dental devices. Its components (treatment chair, dentist's element, assistant's element, dental lamp) facilitate dental procedures but do not diagnose conditions.
No
The device description explicitly lists multiple hardware components including a treatment chair, dentist's element, assistant's element, and dental lamp.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the 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." It's used for supporting and powering dental procedures, not for examining specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The components listed (Treatment Chair, Dentist's Element, Assistant's Element, Dental Lamp) are all physical components used in a dental procedure environment. None of them are designed for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any features related to sample collection, preparation, analysis, or interpretation of results from biological specimens, which are core functions of an IVD.
Therefore, this device falls under the category of a general dental device used for supporting clinical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
EIA
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
- Assistant's Element with Cuspidor, controls automatic and manual air vacuum and suction
- Dental Lamp
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental clinic environment and used by trained dentists and/or dental technicians and assistants.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Pelton & Crane's Spirit S1 - K962071
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.6640 Dental operative unit and accessories.
(a)
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.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
0
DEC 1 1 1998
510(k) Summary for Sirona C8
SPONSOR 1.
Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim, Germany
Contact Person: Walter Schneider Telephone: 49 625 1162 778
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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
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