(275 days)
The dental device is composed by two distinguished and physically connected equipments, that are: dental chair - dental unit (hydro-group) The dental chair is an equipment whose function is to support and position the patient during the dental operations. The dental unit is an equipment connected to the dental chair whose function is to lodge, support and functionally supply the professional instruments used by the dentist and it is combined with accessories. The Continental version can be identified by an instruments table type S.P.R.I.D.O. In this type of table a rod device supports the cord during the activation and the rest of the instrument. The International version can be identified by an instruments table with pending cords. In this type of table resting instruments are hold in specific housings that support them in an almost vertical position, while the cord is pending from the instruments table. The dental device is used by dentist in order to perform dental operations in the dentist's surgery. During the practice and use of the dentist can be helped by an assistant who can use some instruments of the dental unit.
The dental device is composed by two distinguished and physically connected equipments, that are: dental chair - dental unit (hydro-group) The dental chair is an equipment whose function is to support and position the patient during the dental operations. The dental unit is an equipment connected to the dental chair whose function is to lodge, support and functionally supply the professional instruments used by the dentist and it is combined with accessories. The Continental version can be identified by an instruments table type S.P.R.I.D.O. In this type of table a rod device supports the cord during the activation and the rest of the instrument. The International version can be identified by an instruments table with pending cords. In this type of table resting instruments are hold in specific housings that support them in an almost vertical position, while the cord is pending from the instruments table.
This document is an FDA 510(k) clearance letter for a dental operative unit, the "Stern's S250 NordAm" (also referred to as "S250 NordAm"). It does not contain information about acceptance criteria or a study proving that a device (in the context of an AI/software device) meets specific acceptance criteria.
The information provided describes a traditional medical device (a dental chair and unit) and its regulatory clearance process, which focuses on substantial equivalence to a predicate device rather than performance metrics like sensitivity, specificity, accuracy, or reader improvement in an AI context.
Therefore, I cannot provide the requested table and study details. If you have a different document describing an AI/software medical device's performance study, I would be happy to analyze that.
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Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird with three wing-like shapes. The seal is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 4 2010
CEFLA s.c. C/O Mr. Berthoin Claude Denterprise International, Incorporated 110 E. Granada Boulevard, Suite 207 Ormond Beach, Florida 32176
Re: K092917
Trade/Device Name: Stern's S250 NordAm Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: June 4, 2010 Received: June 8, 2010
Dear Mr. Claude:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Claude
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Susan Kinner
Anthony D. Watson, B.S., M.S., M.B.A. 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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INDICATION FOR USE .
Applicant: CEFLA s.c. - CEFLA DENTAL GROUP
510(k) Number (if known):
Device Name: S250 NordAm
Indication For Use:
The dental device is composed by two distinguished and physically connected equipments, that are:
dental chair -
dental unit (hydro-group)
The dental chair is an equipment whose function is to support and position the patient during the dental operations. The dental unit is an equipment connected to the dental chair whose function is to lodge, support and functionally supply the professional instruments used by the dentist and it is combined with accessories.
The Continental version can be identified by an instruments table type S.P.R.I.D.O. In this type of table a rod device supports the cord during the activation and the rest of the instrument.
The International version can be identified by an instruments table with pending cords. In this type of table resting instruments are hold in specific housings that support them in an almost vertical position, while the cord is pending from the instruments table.
The dental device is used by dentist in order to perform dental operations in the dentist's surgery. During the practice and use of the dentist can be helped by an assistant who can use some instruments of the dental unit.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE).
Susa Ginier
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
4510(k) Number: K092917
§ 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.