(90 days)
Not Found
Not Found
No
The summary describes a standard dental implant system and explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is a dental implant intended for the attachment of complete denture prostheses or as an abutment for bridgework or single tooth replacement, which directly addresses a medical condition (edentulous state) and restores function.
No
The device description and intended use indicate it is an implant for dental prostheses, not a tool for diagnosing medical conditions.
No
The device description clearly states it is a Class III dental implant, which is a physical hardware 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's function within the body (implant for dentures, bridges, or single tooth replacement). IVDs are used to examine specimens from the body (like blood, urine, or tissue) to diagnose or monitor conditions.
- Device Description: The description focuses on the physical characteristics and placement of the implant within the patient's mouth.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic testing, or any of the typical activities associated with IVDs.
This device is clearly a medical device intended for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.
Product codes
76DZE
Device Description
These Class III dental implants are supplied sterile, ready for placement by a licensed dentist. There has been no significant change to the prosthetic components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
edentulous mandibles or maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed dentist
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
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Calcitek's existing Spline Dental Implant System
Reference Device(s)
Not Found
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
510(K) SUMMARY RELEASABLE THROUGH FREEDOM OF INFORMATION
Pursuant to 513(i) of the Federal Food, Drug, and Cosmetic Act, as Amended.
| Company Name: | Calcitek, Inc. |
|---|---|
| Address: | 2320 Faraday Avenue, Carlsbad, CA 92008 |
| Telephone Number: | (619) 431-9515 |
| Registration Number: | 2023141 |
| Contact Person: | Donna K. Howard |
| Date Summary Prepared: | May 20, 1996 |
| Classification Name: | Implant, Endosseous (76DZE) |
|---|---|
| Common/Usual Name: | Dental Implant System |
| Device Trade Name: | Spline Dental Implant System |
The primary device used for comparison purposes in this summary is Calcitek's existing Spline Dental Implant System. All implant systems are manufactured in the same facility located in Carlsbad, California.
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- Intended Use: The statements of intended use are identical.
"For use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement."
- Intended Use: The statements of intended use are identical.
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- Description: These Class III dental implants are supplied sterile, ready for placement by a licensed dentist. There has been no significant change to the prosthetic components.
3. Technological Characteristics:
There has been a modification to the apical portion of the implant body to provide the implant with self tapping capabilities. There has been no change to the materials of this device. The implant bodies are offered in both the untextured and textured surfaces. The interface remains unchanged.
4. Comparison Analysis:
The overall design of the implants and prosthetic components are identical to the predicate devices.