(213 days)
Not Found
No
The description focuses on the mechanical and electrical components of a standard dental unit and chair, with no mention of AI or ML capabilities.
No.
The device description indicates that it is a dental unit that supports dental tools and provides a base for dental procedures, rather than directly treating a condition itself.
No
The device is described as supplying power and serving as a base for dental devices, and includes common dental instruments like hand pieces and syringes. It does not perform any diagnostic function.
No
The device description clearly outlines multiple hardware components including a dental chair, operating light, x-ray viewer, control panel, hand pieces, syringe, and foot control.
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 device is "intended to supply power and serve as a base for dental devices and accessories." It's used for dental procedures and examinations within the mouth.
- Device Description: The description details a dental chair, operative units like lights, x-ray viewers, handpieces, etc. These are all tools used directly on or around the patient's mouth for dental treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose or monitor conditions. This dental unit does not fit that description.
N/A
Intended Use / Indications for Use
The Foshion Chair Mounted Dental Unit is intended to supply power and serve as a base for dental devices and accessories. The product includes a dental chair, operating light, x-ray viewer, control panel, low and high speed turbine hand pieces, 3-way syringe and air foot control. The unit is intended for use in the dental office or clinic and is used by trained dentists and/or dental technicians and assistants.
Product codes
KLC
Device Description
The Foshion Chair Mounted Dental Unit is a dental operative unit attached to a dental chair. There are three main parts to the product: a dental chair, a dental unit, and a stool for the dentist. The dental chair has adjustable headrest, backrest, seat with extension for leg support, and armrests. The dental unit consists of a floor box to which are attached a number of operative units: light, x-ray viewer, cuspidor, cup filling device, control panel, instrument tray, and foot control. The instrument panel also includes a 3-way syringe, saliva ejector, air suction, and handpiece attachments
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 office or clinic and is 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6250 Dental chair and accessories.
(a)
Identification. A dental chair and accessories is a device, usually AC-powered, in which a patient sits. The device is intended to properly position a patient to perform dental procedures. A dental operative unit may be attached.(b)
Classification. Class I. The dental chair without the operative unit device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
0
Ko71353
Traditional 510(k)
:
SECTION 5. 510(K) SUMMARY
| Submission
Correspondent: | Keystone Regulatory Services, LLC
342 E. Main Street
Suite 211
Leola, PA 17557
USA | DEC 1 4 2007 |
|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | Phone: 717-656-9656
Fax: 717-656-3434
Email: bill.mclain@keystoneregulatory.com
Contact: William G. McLain
President and Principal Consultant | |
| Submission Sponsor: | Shanghai Foshion Medical Instrument Company, Ltd
No.211 Jiangchang No.3 Rd
Zhabei Borough
Shanghai, China | |
| | Phone: 86-21 51097191
Fax: 86-21 51060057 | |
| Date summary prepared: | May 15, 2007 | |
| Device trade name: | Foshion Chair Mounted Dental Unit | |
| Device common name: | Dental chair with operative unit. | |
| Device classification name: | EIA, Dental Operative Unit, 21 CFR 872.6640 | |
| Legally marketed device to
which the device is
substantially equivalent: | F1 Series Dental Chairs with Operative Unit, K052470. Manufactured by
Shanghai Fimet Medical Instrument Co., Ltd. | |
| Description of the device: | The Foshion Chair Mounted Dental Unit is a dental operative unit attached
to a dental chair. There are three main parts to the product: a dental chair,
a dental unit, and a stool for the dentist. The dental chair has adjustable
headrest, backrest, seat with extension for leg support, and armrests. The
dental unit consists of a floor box to which are attached a number of
operative units: light, x-ray viewer, cuspidor, cup filling device, control
panel, instrument tray, and foot control. The instrument panel also includes
a 3-way syringe, saliva ejector, air suction, and handpiece attachments | |
| Intended use of the device: | The Foshion Chair Mounted Dental Unit is intended to supply power and
serve as a base for dental devices and accessories. The product includes
a dental chair, operating light, x-ray viewer, control panel, low and high
speed turbine hand pieces, 3-way syringe and air foot control. The unit is
intended for use in the dental office or clinic and is used by trained dentists
and/or dental technicians and assistants. | |
| Technological
characteristics: | The technological characteristics between the predicate and proposed
device are similar. Both are chair mounted dental units which supply
power and serve as a base for dental devices and accessories. | |
| Conclusions: | There are no significant differences between the Foshion Chair Mounted
Dental Unit and the predicate device; therefore, the proposed device does
not raise any questions regarding safety and effectiveness. | |
| | The Foshion Chair Mounted Dental Unit, as designed, is as safe and
effective as the predicate device. Comparisons have been made to a
legally marketed predicate device, and the device is determined to be
substantially equivalent to the referenced predicate device currently on the
market. | |
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Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is black and appears to be the only element in the image. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line.
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
DEC 1 4 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Keystone Regulatory Services, LLC C/O Mr. William Mclain Principal Consultant Shanghai Foshion Medical Instruments Company, Limited 342 East Main Street, Suite 211 No. 3 Road Leola, Pennsylvania 17540
Re: K071353
Trade/Device Name: Chair Mounted Dental Unit Regulation Number: 872.6250 Regulation Name: Dental Chair and Accessories Regulatory Class: II Product Code: KLC Dated: November 28, 2007 Received: December 6, 2007
Dear Mr. Mclain:
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.
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Page 2 - Mr. Mclain
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 (QS) 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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Susan Kummer
×19Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4. INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
Indications for Use:
7135
Chair Mounted Dental Unit
The Foshion Chair Mounted Dental Unit is intended to supply power and serve as a base for dental devices and accessories. The product includes a dental chair, operating light, x-ray viewer, control panel, low and high speed turbine hand pieces, 3-way syringe and air foot control. The unit is intended for use in the dental office or clinic and is used by trained dentists and/or dental technicians and assistants.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OF?
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Suxr June
071353