(301 days)
THESE DENTAL CHAIRS ARE AC-POWERED AND INTENDED TO PROPERLY POSITION A PATIENT TO PERFORM ROUTINE DENTAL PROCEDURES. ITS ATTACHED operative dental unit is intended to serve as a base for other dental DEVICES, SUCH AS DENTAL HAND PIECES, AIR OR WATER SYRINGE UNIT ANC OTHER DENTAL DEVICES AND ACCESSORIES. THESE DENTAL UNITS DO NOT HAVE ANY INSTRUMENT OR DEVICE THAT MAY BE USED ON THE PATIENT.
THESE DENTAL CHAIRS ARE AC-POWERED AND INTENDED TO PROPERLY POSITION A PATIENT TO PERFORM ROUTINE DENTAL PROCEDURES. ITS ATTACHED operative dental unit is intended to serve as a base for other dental DEVICES, SUCH AS DENTAL HAND PIECES, AIR OR WATER SYRINGE UNIT ANC OTHER DENTAL DEVICES AND ACCESSORIES. THESE DENTAL UNITS DO NOT HAVE ANY INSTRUMENT OR DEVICE THAT MAY BE USED ON THE PATIENT.
The provided document is a 510(k) premarket notification letter from the FDA for a dental operative unit. This type of document is a regulatory approval letter and does not contain acceptance criteria or study details regarding the performance of an AI/ML powered medical device.
The device described, "Compact Plus, Perfect Plus, Extreme Operative Dental Unit," is a dental chair and an attached operative dental unit intended to properly position a patient for routine dental procedures and serve as a base for other dental devices. It explicitly states, "THESE DENTAL UNITS DO NOT HAVE ANY INSTRUMENT OR DEVICE THAT MAY BE USED ON THE PATIENT."
Therefore, it is a physical medical device, not an AI/ML powered device, and the information requested pertaining to AI/ML model performance, ground truth, expert adjudication, or comparative effectiveness studies is not applicable and cannot be extracted from this document.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
Public Health Service
JUL 17 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Javier Odriozola Suarez Director J.O. Suarez & Cia. Ltda. Rua Saburo Sumiya, No 241 Aldeinha, Barueri, SP BRAZIL 06440-110
Re: K052574
Trade/Device Name: Compact Plus, Perfect Plus, Extreme Operative Dental Unit Regulation Number: 21 CFR 872.6640 Regulation Name: Dental operative unit and accessories Regulatory Class: I Product Code: EIA Dated: June 29, 2006 Received: July 3, 2006
Dear Mr. Suarez:
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. Suarez
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 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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Snylie Y. Michael M.D.
Chíu 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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Indications for Use
ს . ر (k) Number (if known): K052574
Device Name:
COMPACT PLUS, PERFECT PLUS, EXTREME OPERATIVE DENTAL UNIT
Indications For Use:
THESE DENTAL CHAIRS ARE AC-POWERED AND INTENDED TO PROPERLY POSITION A PATIENT TO PERFORM ROUTINE DENTAL PROCEDURES. ITS ATTACHED operative dental unit is intended to serve as a base for other dental DEVICES, SUCH AS DENTAL HAND PIECES, AIR OR WATER SYRINGE UNIT ANC OTHER DENTAL DEVICES AND ACCESSORIES. THESE DENTAL UNITS DO NOT HAVE ANY INSTRUMENT OR DEVICE THAT MAY BE USED ON THE PATIENT.
Prescription Use XDENTIST (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE II NEEDED)
(oncurrence of CDRH, Office of Device Evaluation (ODE)
nesthesiology, General Hospital, lon Control, Dental Devices
Number: K052574
§ 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.