(213 days)
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.
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
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria.
The document is a 510(k) summary for a dental unit, and it focuses on demonstrating substantial equivalence to a predicate device, rather than providing performance data against specific acceptance criteria.
The key points from the provided text are:
- Device Name: Foshion Chair Mounted Dental Unit
- Intended Use: To supply power and serve as a base for dental devices and accessories in a dental office or clinic.
- Technological Characteristics: Similar to the predicate device.
- Conclusion: "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." and "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."
This type of submission (510(k)) often relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than conducting new performance studies against specific, quantitative acceptance criteria. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth, MRMC study, etc.) is not present in this document.
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Ko71353
Traditional 510(k)
:
SECTION 5. 510(K) SUMMARY
| SubmissionCorrespondent: | Keystone Regulatory Services, LLC342 E. Main StreetSuite 211Leola, PA 17557USA | DEC 1 4 2007 |
|---|---|---|
| Phone: 717-656-9656Fax: 717-656-3434Email: bill.mclain@keystoneregulatory.comContact: William G. McLainPresident and Principal Consultant | ||
| Submission Sponsor: | Shanghai Foshion Medical Instrument Company, LtdNo.211 Jiangchang No.3 RdZhabei BoroughShanghai, China | |
| Phone: 86-21 51097191Fax: 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 towhich the device issubstantially equivalent: | F1 Series Dental Chairs with Operative Unit, K052470. Manufactured byShanghai Fimet Medical Instrument Co., Ltd. | |
| Description of the device: | The Foshion Chair Mounted Dental Unit is a dental operative unit attachedto 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 adjustableheadrest, backrest, seat with extension for leg support, and armrests. Thedental unit consists of a floor box to which are attached a number ofoperative units: light, x-ray viewer, cuspidor, cup filling device, controlpanel, instrument tray, and foot control. The instrument panel also includesa 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 andserve as a base for dental devices and accessories. The product includesa dental chair, operating light, x-ray viewer, control panel, low and highspeed turbine hand pieces, 3-way syringe and air foot control. The unit isintended for use in the dental office or clinic and is used by trained dentistsand/or dental technicians and assistants. | |
| Technologicalcharacteristics: | The technological characteristics between the predicate and proposeddevice are similar. Both are chair mounted dental units which supplypower and serve as a base for dental devices and accessories. | |
| Conclusions: | There are no significant differences between the Foshion Chair MountedDental Unit and the predicate device; therefore, the proposed device doesnot raise any questions regarding safety and effectiveness. | |
| The Foshion Chair Mounted Dental Unit, as designed, is as safe andeffective as the predicate device. Comparisons have been made to alegally marketed predicate device, and the device is determined to besubstantially equivalent to the referenced predicate device currently on themarket. |
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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
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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
§ 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.