(224 days)
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.
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.
This 510(k) summary does not describe an AI/ML medical device, but rather a dental implant system (Spline X Endosseous Dental Implant System). Therefore, the specific information requested in your prompt (e.g., acceptance criteria for device performance studies, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is largely not applicable or not provided in the context of this traditional medical device submission.
The document primarily focuses on establishing substantial equivalence to a predicate device (Calcitek's existing Spline Dental Implant System) by demonstrating similar intended use, description, and technological characteristics (design and materials). The "comparison analysis" section reinforces this by highlighting similarities in design, prostheses, and coating material.
Without further information from a different document describing an AI/ML device, I cannot fulfill the request as specified.
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Ka62576
EEB 1 0 1997
510(K) SUMMARY
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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: | June 28, 1996 |
| Classification Name: | Implant, Endosseous (76DZE) |
| Common/Usual Name: | Dental Implant System |
| Device Trade Name: | Spline X Endosseous 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. 1.
"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." -
Description: These Class III dental implants are supplied sterile, ready for 2. placement by a licensed dentist. There has been no significant change to the prosthetic components.
3. Technological Characteristics
Design: There has been no significant change to the overall cylindrical geometry of the implant body or the Spline interface/abutment system. The only difference is the use of a porous titanium coating.
Materials: The materials used for the Spline X Endosseous Dental Implant System (Ti-6Al-4V) are the same as previously mentioned in the premarket notification.
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510(K) SUMMARY
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4. Comparison Analysis:
The overall design of the implants is similar to currently cleared Spline Dental Implant Systems. Prostheses are identical to the Spline predicate devices. The subject implants are coated with a porous coating made from the same titanium material (Ti-6Al-4V) as used in predicate devices.
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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.