(71 days)
Not Found
Not Found
No
The description clearly states the device is a dental chair for patients to sit on during exams and does not have any instruments used on the patient. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of AI/ML.
No
The dental chairs are for patients to sit on during routine dental exams and do not have instruments used on the patient, indicating they are supportive rather than therapeutic.
No
The device is described as dental chairs for patients to sit on during routine dental exams and does not have any instruments for use on the patient, indicating it is not used for diagnosis.
No
The device is described as dental chairs, which are physical hardware devices. The summary explicitly states they are used for patients to sit on and do not have instruments, further confirming their hardware nature. There is no mention of any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for patients to sit on during routine dental exams. This is a physical support function, not a diagnostic test performed on samples taken from the body.
- Device Description: While "Not Found" is listed, the intended use clearly describes a physical chair.
- Lack of Diagnostic Elements: The description explicitly states "THESE CHAIRS DO NOT HAVE ANY INSTRUMENTS THAT MAY BE USED ON THE PATIENT." IVDs involve instruments or reagents used to test samples.
- No Mention of Samples or Analysis: There is no mention of collecting or analyzing biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVDs.
IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. A dental chair does not fit this definition.
N/A
Intended Use / Indications for Use
THESE DENTAL CHAIRS ARE USED SO THAT THE PATIENTS AT THE DENTIST OFFICE MAY SIT ON THEM WHILE THE DENTIST IS PERFORMING ROUTINE DENTAL EXAMS. THESE CHAIRS DO NOT HAVE ANY INSTRUMENTS THAT MAY BE USED ON THE PATIENT.
Product codes
KLC
Device Description
Not Found
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
Dentist Office
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling a bird or abstract human figure, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUM SERVICES USA" is arranged in a circular pattern around the symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 1997
Mr. Jame F. Briggs 'King Dental Corporation 7104 N.W. 72 Avenue Miami, Florida 33166
K971063 Re : Optima Plus "E" Dental Chair, "A" Dental Trade Name: Chair, Excel Chair Requlatory Class: I Product Code: KLC Dated: March 12, 1997 Received: March 24, 1997
Dear Mr. Briggs:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Title 21, Parts 800 to 895. Federal Requlations, A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: Ceneral (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Briggs
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 630-2041 or at (301) 443-6597.
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page_ of
K971063 510(k) Number (if known):
Device Name: OPTINA PLUS "A" DENTAL CHAIR, OPTIMA PLUS "E" DENTAL CHAIR,
EXCEL DENTAL CHAIR
Indications For Use:
THESE DENTAL CHAIRS ARE USED SO THAT THE PATIENTS AT THE DENTIST OFFICE MAY SIT ON THEM WHILE THE DENTIST IS PERFORMING ROUTINE DENTAL EXAMS. THESE CHAIRS DO NOT HAVE ANY INSTRUMENTS THAT MAY BE USED ON THE PATIENT.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Susan Gunner | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K971016 |
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |