(84 days)
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Not Found
No
The device description lists standard disposable dental supplies and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
The device is a collection of instruments and supplies used during dental procedures, not a device that directly treats a condition or disease itself.
No
The device description indicates that Trinity's Dental Tray contains instruments and supplies for performing dental procedures (e.g., cleaning, cavity filling, root canal, tooth removal), not for diagnosing conditions.
No
The device description explicitly lists physical components such as gowns, scalpels, and suction tubing, indicating it is a kit containing hardware, not a software-only device.
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 collection of instruments and supplies for performing basic dental procedures on a patient. This is a direct medical intervention, not a test performed in vitro (outside the body) on a sample.
- Device Description: The device description lists various surgical and procedural tools and supplies used directly in a dental setting. None of these items are typically used for analyzing biological samples to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, Trinity's Dental Tray is a medical device used for performing procedures, not an in vitro diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
Trinity's Dental Tray is a sterile prepackaged disposable unit. It contains the gowns, table cover, mayo stand cover, OR towels, bowl, medicine cup, sponges, scalpels, tongue depressor, foam tray, Yankauer, suction tubing, and towels necessary for the performance of basic dental procedures, including but not limited to general cleaning, cavity filling, root canal, and tooth removal.
Product codes
EIA
Device Description
Dental Tray, Sterile, Disposable
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
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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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 4 1998
Mr. Partha Basumallik Vice President Trinity Laboratories, Incorporated 201 Kiley Drive Salisbury, Maryland 21801
K974238 Re : Dental Tray, Sterile, Disposable Trade Name: Requlatory Class: I Product Code: EIA Dated: November 5, 1997 Received: November 12, 1997
Dear Mr. Basumallik:
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 reqistration, 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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
1
Page 2 - Mr. Basumallik
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to beqin 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) 638-2041 or (301) 443-6597 or at its internet address "http://www.fpa.gov/cdrh/dsmamain.html".
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
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Page 1 Of _ 1_
510 (k) Number (if Known):
Device Name: Dental Tray
Indications for Use:
Trinity's Dental Tray is a sterile prepackaged disposable unit. It contains the gowns, table cover, mayo stand cover, OR towels, bowl, medicine cup, sponges, scalpels, tongue depressor, foam tray, Yankauer, suction tubing, and towels necessary for the performance of basic dental procedures, including but not limited to general cleaning, cavity filling, root canal, and tooth removal.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __ ﮯ (Per 21 CFR 801.109)
OR
Over-the-Counter Use _
(Optional Format 1-2-96)
SWAAN RUMPE
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 11.7 510(k) Number