(90 days)
Not Found
Not Found
No
The summary describes a standard dental implant system and does not mention any AI or ML components or functionalities.
Yes
The device is a dental implant intended for attachment of dental prostheses or as a tooth replacement, which directly addresses a medical condition (edentulism) by restoring function and preventing further issues.
No
Explanation: The device is a dental implant used for prosthetic attachment or tooth replacement, not for identifying a disease or condition.
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 (implanting into bone for prosthetic attachment). This is a therapeutic or restorative purpose, not a diagnostic one.
- Device Description: The description focuses on the physical nature of the implant and its placement by a dentist. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening
- Using reagents or assays
In summary, this device is a dental implant, which is a medical device used for surgical implantation and prosthetic support, not for in vitro diagnostic testing.
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. 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. The overall design of the implants and prosthetic components are identical to the predicate devices.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Calcitek's existing Uncoated ThreadLoc 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
FEB 25 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: | Joseph S. Shan |
| Date Summary Prepared: | November 25, 1996 |
| Classification Name: | Implant, Endosseous (76DZE) |
| Common/Usual Name: | Dental Implant System |
| Device Trade Name: | ThreadLoc Dental Implant System |
The primary device used for comparison purposes in this summary is Calcitek's existing Uncoated ThreadLoc 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. ﺎ .
"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 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.