(107 days)
No
The 510(k) summary describes dental implant components and does not mention AI or ML technology.
No.
The intended use describes the device as components for a dental implant system. While dental implants can improve patient well-being, the components themselves are not described as having a direct therapeutic function to treat or cure a specific condition, but rather as supportive elements for the implant.
No
The "Dual Integrator" Healing Cap, Implant Carrier Assembly, and Activator Pin Driver are described as components intended for use with a dental implant system. Their function is related to the implantation process (e.g., healing, carrying, driving), not to the identification or analysis of a medical condition or disease.
No
The 510(k) summary describes physical components (Healing Cap, Implant Carrier Assembly, Activator Pin Driver) intended for use with a dental implant, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used with a dental implant system. This indicates a surgical or restorative application within the body, not a test performed on samples outside the body to diagnose a condition.
- Device Description (Not Found): While the description is missing, the context of "Healing Cap, Implant Carrier Assembly, and Activator Pin Driver" strongly suggests components used in dental implant procedures.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's intended use falls outside of that definition.
N/A
Intended Use / Indications for Use
The "Dual Integrator" Healing Cap, Implant Carrier Assembly, and Activator Pin Driver are all intended to be used with the Implant Integration Systems "Dual Integrator" Dental Implant (K944225).
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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): 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.
Minimatic Implant Tech. BC 1213 Healing Screw (K904709)
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.
Dental Imaging Assoc. Dia Healing Cap (K902434), Minimatic Implant Tech. HS-1113 Healing Screw (K903062), Implant Innovations Int. Innovative Implants and Cover Screws (K874590)
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).
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
Image /page/0/Picture/0 description: The image shows the text "Implant Integration Systems, Inc." in a bold, serif font. Above this text, there is a stylized, handwritten-style text that appears to be a logo or brand mark. The text "Implant Integration Systems, Inc." is underlined, emphasizing the name of the company. The overall impression is that of a company logo or letterhead.
6161 Clark Road, Suite 8 · Paradise, CA 95969 USA · (916) 872-1020 · Fax: (916) 877-7555
Summary of Safety and Effectiveness Information
OCT 18 1996
The "Dual Integrator" Healing Cap, Implant Carrier Assembly, and Activator Pin Driver are all intended to be used with the Implant Integration Systems "Dual Integrator" Dental Implant (K944225).
This product is similar in design, composition (Pure-Ti CP-3, Ti Alloy CP-4, and stainless steel) and function to the Minimatic Implant Tech. BC 1213 Healing Screw (K904709), the Dental Imaging Assoc. Dia Healing Cap (K902434), the Minimatic Implant Tech. HS-1113 Healing Screw (K903062), the Implant Innovations Int. Innovative Implants and Cover Screws (K874590), as well as, healing screws/caps and tools from any other implant system.
Cory D. Hanosh, Sales Manager
Cory D. Hanosh, Sales Manager
7-1-96
Date