(156 days)
The Logos Junior dental unit and accessories are indicated for the provision of dental treatment in the dental operatory by dentists, dental assistants and dental hygienists.
LOGOS JUNIOR DENTAL CHAIR AND UNIT
The provided document is a 510(k) clearance letter from the FDA for a dental chair and unit (Logos Junior Dental Chair and Unit, K023513). This document is not a study report for an AI/ML medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, device performance, study design, or ground truth establishment for such a device.
The letter explicitly states that the device is a "Dental Operative Unit and Accessories" and its indication for use is "for the provision of dental treatment in the dental operatory by dentists, dental assistants and dental hygienists."
To answer your questions, I would need a different type of document, specifically a study report or clinical validation report for an AI/ML medical device.
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Public Health Service
9200 C
Rockvi
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Giuliano Lanzarini Responsible for Product Safety Castellini S.p.A. Via Saliceto, 22 40013 Castel Maggiore Bologna, ITALY
Re: K023513
Trade/Device Name: Logos Junior Dental Chair and Unit Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: January 16, 2003 Received: January 21, 2003
Dear Mr. Lanzarini:
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.
MAR 2 6 2003
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 vour 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. Lanzarini
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 vour 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,
Susan Ruane HPLfor
Susan Runner, DDS, MA Interim 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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Page 1 of 1
510(k) Number (if known): K023513
Device Name:LOGOS JUNIOR DENTAL CHAIR AND UNIT
Indications For Use: The Logos Junior dental unit and accessories are indicated for the provision of dental treatment in the dental operatory by dentists, dental assistants and dental hygienists.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Suzen Ranna
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division of Anesthesiology, General Devices Division of Ancolnection of Antal Devices
510(k) Number: I902357
ANINIE V 1
§ 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.