(14 days)
Not Found
No
The 510(k) summary describes a standard dental chair and operative unit with basic power and supply functions, and there is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML.
No.
The device functions as a base and power supply for dental devices and accessories, and provides patient comfort with air and water supplies. It does not directly provide a therapeutic effect or treat a disease.
No
The device description states it provides patient comfort and supplies air and water for dental instruments and procedures, serving as a base for dental devices. It does not mention any function for diagnosing conditions or diseases.
No
The device description explicitly states it includes a "dental chair" and provides "air and water supplies," indicating it is a hardware device with physical components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "supply power to and serve as a base for dental devices and accessories" and provide "patient comfort and dentists' air and water supplies for dental instruments and procedures." This describes a piece of equipment used during dental procedures, not a device used to test samples outside the body to diagnose conditions.
- Device Description: The description focuses on the physical aspects of the chair and the provision of air and water, which are essential for dental work but not related to in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, this device is a piece of dental equipment used in a clinical setting to facilitate dental procedures, not a diagnostic tool that performs tests on samples outside the body.
N/A
Intended Use / Indications for Use
SDIF dental chairs with Operative Unit is intended for use to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants.
Product codes (comma separated list FDA assigned to the subject device)
EIA
Device Description
SDIF dental chairs with operative units provide patient comfort and dentists' air and water supplies for dental instruments and procedures. Water pressure: 200~400Kpa. Air water Supplios for dontar mounts can be powered from ~110/220/230V. The chair is protoure. The system is compatible with instruments from various manufacturers with standard fittings.
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
used by trained dentists and/or dental technicians and assistants in the dental clinic/office environment
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K06 3302
NOV 1 5 2006
510(k) Summary As Required by 21 section 807.92 ( c )
SHANGHAI DENTAL INSTRUMENT FACTORY CO., LTD 1-Submitter Name: ("SDIF") 820 LINGSHI ROAD, SHANGHAI CHINA 200072 2-Address: Tel +86 21 66255988. 3-Phone: Fax +86 21 56956197 4-Fax: Ms Chen Yimei, Vice General Manager 5-Contact Person: 5-Consultant: Jay Mansour, Mansour Consulting LLC, 845 Aronson Lake Court, Roswell, GA 30075 USA. Tel 678-908-8180. Fax 678-623-3765 7-Date summary prepared: October 26th, 2006 8-Device Trade or Proprietary Name: SDIF Dental chair with Operative Unit and accessories 9-Device Common or usual name: Dental chair with operative unit 10-Device Classification Name: Chair, Dental, with Operative unit 11-Substantial Equivalency is claimed against the following device: K052470
12-Description of the Device:
SDIF dental chairs with operative units provide patient comfort and dentists' air and water supplies for dental instruments and procedures. Water pressure: 200~400Kpa. Air water Supplios for dontar mounts can be powered from ~110/220/230V. The chair is protoure. The system is compatible with instruments from various manufacturers with standard fittings.
13-Intended use of the device:
SDIF dental chairs with Operative Unit is intended for use to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants.
14-Safety and Effectiveness of the device:
This device is safe and effective as the other predicate device cited above.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shanghai Fimet Medical Instrument Company, Limited C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
NUV 15 2006
Re: K063302
Trade/Device Name: SDIF Dental Chairs with Operative Unit Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: October 30, 2006 Received: November 1, 2006
Dear Mr. Job:
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.
2
Page 2 - Mr. Job
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 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.
Snite y. Michien M.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: SDIF DENTAL CHAIRS WITH OPERATIVE UNIT
Indications For Use:
SDIF Dental chairs with operative unit is indicated for use to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is indicated for use in the dental clinic/office environment used by trained dentists and/or dental technicians and assistants
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rumer
:
Sign-Off)
en of Anesthesiology, General Hospital,
con Control, Dental Devices
) Fiumber:
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