(224 days)
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No
The summary describes a physical dental implant and does not mention any software, image processing, or AI/ML terms.
Yes
The device is a dental implant intended for the attachment of complete denture prostheses or as an abutment for bridgework or a single tooth replacement, which directly treats the condition of edentulism and restores oral function, fitting the definition of a therapeutic device.
No
Explanation: The device is a dental implant used for attachment of prostheses or as an abutment. It does not perform any diagnostic function.
No
The device description explicitly 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 (implanting into bone for prosthetic attachment). This is a surgical/implantable device, not a device used to test samples in vitro (outside the body).
- Device Description: The description confirms it's a dental implant, which is a physical device placed within the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, this device falls under the category of a medical device, specifically a dental implant, rather than an IVD.
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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
edentulous mandibles or maxillae
Indicated Patient Age Range
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Intended User / Care Setting
licensed dentist
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
Ka62576
EEB 1 0 1997
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: | 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.
RELEASABLE THROUGH FREEDOM OF INFORMATION
1
510(K) SUMMARY
RELEASABLE THROUGH FREEDOM OF INFORMATION
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.
RELEASABLE THROUGH FREEDOM OF INFORMATION
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