(203 days)
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No
The summary describes a standard dental operating unit and contains no mention of AI, ML, or related concepts like image processing or performance metrics typically associated with AI/ML devices.
No
The device is a "dental operating unit system" intended to support "general, nonsurgical dental diagnostic and restorative procedures"; it is not described as directly treating a disease or condition.
No
The "Intended Use" states it supports "general, nonsurgical dental diagnostic and restorative procedures," but the device itself is a "Dental Operating Unit," which is equipment used during procedures, not a distinct diagnostic tool to identify conditions.
No
The device description explicitly states "Dental Operating Unit," which is a hardware system used in dental procedures. The summary does not mention any software-only components or functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a "dental operating unit system" used for "general, nonsurgical dental diagnostic and restorative procedures." This involves direct interaction with the patient and performing procedures within the mouth.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. They are used outside the body (in vitro).
- Lack of IVD Characteristics: The description does not mention analyzing any biological specimens or providing diagnostic information based on such analysis. It focuses on supporting dental procedures performed directly on the patient.
Therefore, this dental operating unit system falls under the category of a general medical device used in a clinical setting, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This dental operating unit system is intended for use by professionally trained demists and their supervised dental hygienists and assistants to support their general, nonsurgical dental diagnostic and restorative procedures performed within contemporary standards of dental patient care. When properly used and cared for, the system is safe and effective and meets advertised claims. When equipped with isolated patient water (bottle) system that is properly installed and cared for, it has been shown to reduce the number of microbes in the water dispensed.
Product codes
EIA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
professionally trained demists and their supervised dental hygienists and assistants
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1098 AUG
Mr. Frank A. Betush Quality Manager Proma, Incorporated 751 East Kingshill Place Carson, California 90746-1223
Re : K980106 The Proma Perception, Response and Compass Trade Name: System and Accessories Regulatory Class: I Product Code: EIA Dated: April 24, 1998 Received: May 5, 1998
Dear Mr. Betush:
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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (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 regulation 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 requlations.
1
Page 2 - Mr. Betush
This letter will allow you to begin marketing your device as The FDA described in your 510(k) premarket notification. 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) 594-4692. 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) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
S. Autman for
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
Form revised at FDA request-2nd revision 24 Apr 98
Indications for use Form Page (1 of 1)
| 510 (K) number (if known): | K# 980106 |
|---|---|
| Device name: | Dental Operating Unit |
| Indications for use: |
This dental operating unit system is intended for use by professionally trained demists and their supervised dental hygienists and assistants to support their general, nonsurgical dental diagnostic and restorative procedures performed within contemporary standards of dental patient care. When properly used and cared for, the system is safe and effective and meets advertised claims. When equipped with isolated patient water (bottle) system that is properly installed and cared for, it has been shown to reduce the number of microbes in the water dispensed.
(Please do not write below this line-continue on another page)
(concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Susan Runge
(Division Sisin-Off) (Division Sign-Off)
Division Sign-Off, Infection Control, . . . . Devices and Genera 169010 510(k) Number -
OR Over-The-Counter Use
(Optional Format 1-2-96)