(35 days)
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No
The summary describes a simple, disposable dental tray with pre-packaged components and makes no mention of AI or ML technology.
No
The device is a general purpose dental tray that provides auxiliary components for dental procedures, it does not administer therapy itself.
No
The device is described as a "General Purpose Dental Tray" which provides "auxiliary components" and "commonly used items" for the administration of dental procedures. There is no mention of it being used to identify or diagnose conditions.
No
The device description clearly states it is a physical, disposable tray containing auxiliary components for dental procedures, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "conveniently provide general use auxiliary components for the administration of dental procedures." This describes a device used during a medical procedure, not a device used to test samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description reinforces that the components are "commonly used during a variety of dental procedures." This further indicates a procedural aid, not a diagnostic tool.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, genes, etc.)
- Providing diagnostic information about a patient's health status.
Therefore, the General Purpose Dental Tray is a medical device used in dental procedures, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The General Purpose Dental Tray is a single patient, single use, disposable device which is intended to conveniently provide general use auxiliary components for the administration of dental procedures.
Product codes
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Device Description
The General Purpose Dental Tray is intended to conveniently provide the auxiliary components utilized during general dental procedures. The components are items that are commonly used during a variety of dental procedures. The general Purpose Dental Tray provides the convenience of having these commonly used items packaged in a single package, sterile, and ready to use. The kits are provided sterile, disposable, and for single patient use.
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.
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Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters, likely a combination of letters and numbers. The sequence starts with the letter 'K', followed by the numbers '962527'. The characters are written in a cursive style, with some connections between the letters and numbers. The overall impression is that of a handwritten code or identifier.
AUG - 1 1996
510(k) Summary: (1)
This summary is submitted in conformance with the format described in the 21 CFR Part 807.92 interim rule dated April 28, 1992.
- (1) Submitted By:
MedCare Medical Group, Inc. 234 Old Homestead Highway E. Swanzey, NH 03446
Contact Person:
Craig J. Bell Director of Research and Development (603)352-3230
- (2) Name of Device:
General Purpose Dental Tray
Classification Name:
Unknown
- Identification of Predicate Devices: (3)
Sterile Dental Systems, Inc. Operative Pack
Sterile Concepts Richmond, VA 23234
1
(4) Description of Device Subject to Premarket Notification:
The General Purpose Dental Tray is intended to conveniently provide the auxiliary components utilized during general dental procedures. The components are items that are commonly used during a variety of dental procedures. The general Purpose Dental Tray provides the convenience of having these commonly used items packaged in a single package, sterile, and ready to use. The kits are provided sterile, disposable, and for single patient use.
(5) Intended Use of the Device:
The General Purpose Dental Tray is a single patient, single use, disposable device which is intended to conveniently provide general use auxiliary components for the administration of dental procedures.
(6) Technological Characteristics
The MedCare General Purpose Dental Tray is similar to the predicate device in that both of the device provide a variety of auxiliary components for the convenient administration of dental procedures. Both devices provide flexibility in componentry selection for kit customization , which provides the maximum convenience for the customer.