(88 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no description of training or test sets, performance studies, or key metrics typically associated with AI/ML devices. The device description focuses on mechanical and electrical components and optional video system.
No.
The device is described as a dental operative unit that supplies power to and serves as a base for dental devices and accessories, including a patient treatment chair and an optional intraoral camera. It enables dental procedures but does not directly provide therapy.
No
The device is primarily an operative unit for dental procedures. While it includes an optional intraoral camera system (Sivision 3) that provides video images of the teeth and oral cavity, its stated "Intended Use" is to "supply power to and serve as a base for dental devices and accessories," and the camera system is described as providing images "to view the condition" rather than explicitly for diagnosis. The device's main function is to facilitate treatment, not to interpret or analyze medical data for diagnostic purposes.
No
The device description clearly lists multiple hardware components such as a patient treatment chair, dentist's element, assistant's element, water unit, and overhead dental light. While it mentions an optional video system (SIVISION 3) which includes an intraoral camera and monitor, the core device is a physical dental operative unit.
Based on the provided information, the C8+ Dental Operative Unit with accessories is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The primary intended use is to supply power and serve as a base for dental devices and accessories, and to provide intraoral video images for viewing the condition of teeth and the oral cavity. This is a diagnostic imaging function, not an in vitro diagnostic function.
- Device Description: The components listed (chair, elements, water unit, light) and the accessories it powers (turbines, scalers, etc.) are all used for direct patient treatment or imaging within the oral cavity.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide diagnostic information. IVD devices are specifically designed for testing biological samples in a laboratory or clinical setting.
The optional Sivision 3 intraoral camera system is a diagnostic imaging tool, but it is not an in vitro diagnostic device. It captures images directly from the patient's body.
N/A
Intended Use / Indications for Use
The C8+Dental Operative Unit with accessories 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.
The C8+ Dental Operative Unit is offered with the optional Sivision 3 intraoral camera system, which is intended to provide the dentist and patient with intraoral video images to view the condition of the teeth and oral cavity.
The C8+Dental Operative Unit with accessories is intended to supply power to and serve as a basc for dental devices and accessories. This product includes a dental The unit is intended for use in the dental clinic environment and used by chair. trained dentists and/or dental technicians and assistants.
The CB+ Dental Operative Unit is offered with the optional Sivision 3, an intraoral camera system intended to provide the dentist and patient with intraoral video images to view the condition of the teeth and oral cavity.
Product codes (comma separated list FDA assigned to the subject device)
EIA
Device Description
The C8+ is a modification of the C8 Dental Operative Unit and includes some features previously available on the Spirit S1 Dental Operative Unit. The C8+ consists of the following major components:
- Patient Treatment Chair ●
- . Dentist's Element
- Assistant's Element
- Water Unit with Cuspidor
- Overhead Dental Light
The C8+ can supply power to five (5) dental instruments, which may include an air water syringe, high and low speed turbines and electric motors, ultrasonic scalers, intraoral X -ray film viewer, fiber optic light instruments, dental curing light, water warmers, airscaler, and an air polisher. These accessories are not part of the C8+ dental operating unit 510(k). The C8+ also offers an optional built-in disinfection apparatus and an optional video system, SIVISION 3, which consists of an intraoral camera and a flat-screen LCD monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
intraoral video images
Anatomical Site
teeth and oral cavity
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.
C8 Dental Operative Unit with Accessories, K983242, Spirit S1 Dental Operative Unit with Accessories, 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
NOV 1 4 2003
510(k) Summary
for
Sirona Dental Systems C8+ Dental Operative Unit with Accessories
SPONSOR 1.
Sirona Dental Systems GmbH Farbrikstrasse 31 64625 Bensheim Germany
2. DEVICE NAME
| Proprietary Name: | C8+ Dental Operative Unit |
|---|---|
| Common/Usual Name: | Dental Operative Unit |
| Classification Name: | Dental Operative Unit with Accessories |
3. PREDICATE DEVICES
C8 Dental Operative Unit with Accessories, K983242
Spirit S1 Dental Operative Unit with Accessories, K962071
INTENDED USE 4.
The C8+Dental Operative Unit with accessories 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.
The C8+ Dental Operative Unit is offered with the optional Sivision 3 intraoral camera system, which is intended to provide the dentist and patient with intraoral video images to view the condition of the teeth and oral cavity.
1
ડ. DEVICE DESCRIPTION
The C8+ is a modification of the C8 Dental Operative Unit and includes some features previously available on the Spirit S1 Dental Operative Unit. The C8+ consists of the following major components:
- Patient Treatment Chair ●
- . Dentist's Element
- Assistant's Element
- Water Unit with Cuspidor
- Overhead Dental Light
The C8+ can supply power to five (5) dental instruments, which may include an air water syringe, high and low speed turbines and electric motors, ultrasonic scalers, intraoral X -ray film viewer, fiber optic light instruments, dental curing light, water warmers, airscaler, and an air polisher. These accessories are not part of the C8+ dental operating unit 510(k). The C8+ also offers an optional built-in disinfection apparatus and an optional video system, SIVISION 3, which consists of an intraoral camera and a flat-screen LCD monitor.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The Sirona Dental Systems C8+ Dental Operative Unit with Accessories is substantially equivalent to the Sirona Dental Systems Sirona C8, K983242, and the Spirit S1 Dental Operative Unit, K962071. The C8+ has the same intended use as the predicates in that they are all used to supply power to, and serve as a base for dental devices and accessories.
The technological characteristics of the proposed and predicate devices are the same in that they include similar components, and are similar in design, characteristics, and mode of operation. Both the proposed and predicate devices include a chair, dentist's instrument board, cuspidor, assistant's board, dental light and footswitches for control of the various components. The C8+ includes various options also offered on either the C8 or the Spirit S1. The C8+ also includes additional features that do not change the fundamental technology of the device or raise new questions of safety or effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2003
Ms. Mary McNamara-Cullinane Regulatory Affairs Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K032543
Trade/Device Name: Sirona Dental Systems C8+ Dental Operative Unit with Accessories Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: August 15, 2003 Received: August 18, 2003
Dear Ms. Cullinane:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Ms. Cullinane
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Ques
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
510(k) Number (if known): K032543
Device Name: Sirona Dental Systems C8+ Denlal Operative Unit with Accessories
Indications for Use:
The C8+Dental Operative Unit with accessories is intended to supply power to and serve as a basc for dental devices and accessories. This product includes a dental The unit is intended for use in the dental clinic environment and used by chair. trained dentists and/or dental technicians and assistants.
The CB+ Dental Operative Unit is offered with the optional Sivision 3, an intraoral camera system intended to provide the dentist and patient with intraoral video images to view the condition of the teeth and oral cavity.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
nesthesiology, General Hospital,
510(k) Number. K032543
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use -
Sirona Dental Systems 510(k) C8+ Dental Operative Unit with Accessories
November 10, 2003