(199 days)
Not Found
No
The summary describes a standard dental implant and does not mention any AI or ML components or functionalities.
No.
The device is described as "surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices," indicating it is a structural support for prosthetics rather than a device intended to treat or prevent a disease or condition.
No
The document describes a dental implant, which is a prosthetic device for support, not a tool for diagnosing medical conditions.
No
The device description clearly states it is a physical titanium dental implant, which is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices." This describes a device that is implanted into the body for a structural purpose.
- Device Description: The description of a "titanium endosseous implant" further reinforces that it's a physical device intended for implantation.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does none of those things.
- No Mention of Biological Samples or Analysis: The description and intended use do not involve the collection or analysis of any biological samples.
Therefore, based on the provided information, this device is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The titanium endosseous implant is a device intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices.
Product codes
76DZE
Device Description
A cylinder shaped commercially pure titanium dental implant with external threads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
bone of the upper or lower jaw arches
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies
Not Found
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
"O" Company, Inc.
Dental Implant & Attachment Systems 600 Paisano NE Albuquerque, NM 87123
510(K) SUMMARY
961665
April 22, 1996
| Contact Person: | David D. Dalise
President / owner, “O” Company, Inc. |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | “O” Butment ET Implant |
| Common Name: | Endosseous Screw Implant |
| Classification Name: | Dental Implant Endosseous / Code 76DZE |
| Substantial Equivalence to: | “O” Butment ES Implant referenced as K923889 and
Screw-Vent Implant referenced as K900179 |
| Description of Device: | A cylinder shaped commercially pure titanium dental
implant with external threads. |
| Intended Use: | The titanium endosseous implant is a device intended to be surgically
placed in the bone of the upper or lower jaw arches to provide support for
prosthetic devices. |
| Substantial Equivalence: | Substantial Equivalence for the “O” Butment ET Implant is
is based on the following comparison of predicate devices such as “O”
Company’s “O” Butment ES Implant and Dentsply’s Screw Vent
Implant. The design, function, labeling, material composition and intended
use is equivalent to the devices currently marketed. |
| Non-clinical tests: | Based on lateral and vertical stress analysis performed by Rocky Mountain
Testing, it has been determined that the physical integrity of the implant
has not been compromised by the modifications. |
This data supports our determination that the "O" Butment is substantially equivalent to the "O" Company's "O" Butment ES Implant (K923889)
FAX (505) 293-0447