(88 days)
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No
The summary describes a standard dental implant and does not mention any AI or ML components or functionalities.
Yes
The device is a dental implant intended for the attachment of dental prostheses or as a tooth replacement, which directly involves restoring or replacing missing body parts for therapeutic purposes.
No
Explanation: The device is a dental implant intended for attachment of dental prostheses or as a tooth replacement. Its function is to provide structural support, not to diagnose a condition or disease.
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 a device used in the body (edentulous mandibles or maxillae) for the attachment of prostheses. IVDs are used outside the body to examine specimens (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description states it's a "dental implant" that is "placed by a licensed dentist." This confirms it's an implantable device used in a surgical procedure, not a diagnostic test performed on a specimen.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a medical device, specifically a dental implant, rather than 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
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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
-8 K-955619
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: | December 4, 1995 |
| Classification Name: | Implant, Endosseous (76DZE) |
|---|---|
| Common/Usual Name: | Dental Implant System |
| Device Trade Name: | 5.0mm Spline 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.
- 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."
- 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 design of these parts.
Materials: The materials used for the are the same as previously mentioned out in the premarket notifications. The material specifications remain unchanged.
SUMMARY INFORMATION - RELEASABLE THROUGH FOI
1
510(K) SUMMARY RELEASABLE THROUGH FREEDOM OF INFORMATION
Comparison Analysis: 4.
The overall design of the implants and prostheses is identical to the predicate devices. The subject implants and components have been scaled up to the 5.0mm size. Given that mechanical strength is generally a function of crosssection and material properties, and that identical materials are used to manufacture the 5.0mm implants and prostheses, it is expected that the 5.0mm components will be stronger than the predicate devices.