(664 days)
Not Found
Not Found
No
The provided 510(k) summary contains no information about the device description, intended use, or any mention of AI, ML, or related concepts.
No
The provided information is all "Not Found," so there is no basis to determine if the device is therapeutic.
No
The provided information indicates "Not Found" for "Intended Use / Indications for Use" and "Device Description," which are key sections for determining if a device is diagnostic. Without this information, it's not possible to definitively state its diagnostic nature.
Unknown
The provided 510(k) summary is completely empty, offering no information about the device's nature, components, or function. Therefore, it's impossible to determine if it's a software-only medical device.
Based on the information provided, it is impossible to determine if this device is an IVD.
The document contains "Not Found" for all the key sections that would typically describe a medical device, including its intended use, description, and any mention of diagnostic processes.
To determine if it's an IVD, you would need information about:
- Intended Use: Does it analyze samples taken from the human body (like blood, urine, tissue)?
- Device Description: What does the device actually do?
- Any mention of diagnostic testing: Does it perform tests to diagnose diseases or conditions?
Without any of this information, we cannot classify the device.
N/A
Intended Use / Indications for Use
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Product codes
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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
Not Found
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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§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
KG5505
Image /page/0/Picture/1 description: The image shows a close-up of a graphic with text and a simple illustration. On the right side, the text "Minimatic Implant Systems" is printed in a bold, sans-serif font. To the left of the text, there are three vertical, rectangular shapes that appear to be stylized representations of implants. The shapes are white with black outlines, and they are arranged side by side. Above the shapes and text, there is a thick, black horizontal line.
"Tomorrow's Technology Today"
APR 1 6 1997
June 23, 1995
FDA LOU HIAVINKA HFZ-410 DEVICE CONTROL 9200 CORPORATE BLVD 20856 ROCKVILLE, MD
510K Summary
510K REVIEW AND UPDATE. RE:
Minimatic attests that:
- Minimatic is the designer, manufacturer, and 1. marketer of the enclosed devices.
- The devices are Dental devices that currently are 2. classified in Class III.
- The devices are substantially equivalent to devices 3. currently being marketed.
- The devices in and of themselves are considered safe 4 . and effective provided that the devices are utilized as intended.