K Number
K160221
Date Cleared
2016-09-12

(227 days)

Product Code
Regulation Number
872.3640
Panel
DE
Reference & Predicate Devices
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Implance Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function.

Implance Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading.

Immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implants.

Implance Dental Abutment System is used with a dental implant to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as bridge or overdenture.

Device Description

The Implance Dental Implant System consists of titanium alloy dental implants and titanium closing screws. The Implance Dental Implants are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore the patient's chewing function. The surface of the implant is sand-blasted with a resorbable blast media (RBM). The provided closing screw covers the Implance Dental Implant during the healing process.

The Implance Dental Implants (Table 1) are either bone level or tissue level type implants and are available in multiple designs. Bone Level Implants primarily contact bone, whereas the Tissue Level implant contacts bone and tissue along the cuff portion of the dental implant.

The Implance Dental Abutment System (Table 2), consisting of titanium temporary and final abutments and screws, provides the link between the Implance Dental Implant and the prosthesis that forms the superstructure and allows chewing. Final, permanent abutments are available in multiple designs and range in diameter from 2.9 mm to 6.5 mm; cuff heights of 0.5 mm to 5 mm and lengths of 7 mm to 16.4 mm.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Implance Dental Implant System and Implance Dental Abutment System. The focus of the provided text is on demonstrating substantial equivalence to predicate devices, rather than establishing new acceptance criteria or conducting a study to prove a device meets new acceptance criteria. The performance data presented are primarily non-clinical and aim to show that the new device performs comparably to the predicate devices and meets existing standards.

Therefore, the requested information elements related to user studies, sample sizes for test sets, expert-established ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details are not applicable to this type of device submission as described.

However, I can extract the acceptance criteria (standards and guidance documents used) and the reported device performance based on the non-clinical testing conducted to support substantial equivalence.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for demonstrating substantial equivalence are based on established FDA guidance and international standards for dental implants and abutments. The device's performance is demonstrated through non-clinical testing to show compliance with these standards and comparability to predicate devices.

Table 1: Acceptance Criteria and Reported Device Performance

Category / TestAcceptance Criteria (Reference Standard/Guidance)Reported Device Performance
Premarket Notification (General)Substantial Equivalence to Legally Marketed Predicate Devices (pre-May 28, 1976 or reclassified)Determined to be substantially equivalent to the Dentis Dental Implant System (K073486) and Klockner Dental implant abutment (K122988) based on intended use, material composition, basic design, dimensions, and surface treatment.
Material Standards (Implants)ASTM F-67 (Titanium Grade 4) & ASTM F-136-13 (Titanium Grade 5)Implants made of Titanium Grade 4 & 5, meeting referenced ASTM standards.
Material Standards (Abutments)Titanium Grade 5 (Bone Level 3.3 & 3.7 mm implants), Titanium Grade 4 ASTM F-67 (Bone Level 4.3; 4.8; 5.5 mm and Tissue Level implants), Screw: Titanium Grade 5 ASTM F136Abutments made of specified Titanium grades, meeting referenced ASTM standards.
Biocompatibility- ISO 10993-5:2009 (Cytotoxicity)
  • ISO 10993-10:2010 (Sensitization, Irritation/Intracutaneous)
  • ISO 10993-11:2006 (Acute systemic toxicity, Subchronic toxicity)
  • ISO 10993-3:2003 (Genotoxicity)
  • ISO 10993-6:2007 (Implantation)
  • FDA Class II Special Controls Guidance Document (Root-form Endosseous Dental Implants and Endosseous Dental Abutments) | All biocompatibility tests found the materials used in the Implance Dental Implant & Implance Dental Abutment Systems to be biocompatible. |
    | Surface Treatment Analysis | Homogeneity of surface and elemental analysis (general acceptance for RBM surfaces) | SEM analysis of RBM surface found homogeneous surface; Energy-dispersive X-ray spectroscopy provided elemental analysis and chemical characterization after washing. |
    | Sterilization Validation (Implants) | - SAL of 10⁻⁶
  • Packaging sufficient to maintain sterility for 5-year shelf life | Gamma ray sterilization validated to ensure a SAL of 10⁻⁶. Packaging tests (Adhesion Strength Control Force (Seal Strength), Package Tightness (Seal Leak) Test, and Sterility Test) confirmed maintenance of sterility for a 5-year shelf life. |
    | Sterilization Validation (Abutments) | - SAL of 10⁻⁶ (for end-user performed sterilization) | Provided non-sterile. Sterilization parameters for end-user (steam gravity sterilization method) validated to achieve a SAL of 10⁻⁶. |
    | Mechanical Testing (Dynamic Fatigue) | ISO 14801 Dentistry-Implants-Dynamic fatigue test for Endosseous dental implants
  • FDA Class II Special Controls Guidance Document | Fatigue testing on worst-case bone level implant/abutment combinations found results consistent with FDA Class II Special Controls guidance and ISO 14801, demonstrating substantially equivalent performance. |

Detailed Information on the Study (as applicable to this 510(k) submission):

  1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

    • This document describes non-clinical performance testing (e.g., in-vitro biocompatibility, materials characterization, mechanical fatigue tests). The concept of a "test set" and "data provenance" as typically applied to human clinical studies or AI algorithm evaluation is not directly relevant here. The "samples" would refer to the physical devices or materials subjected to laboratory tests. Specific sample sizes for each non-clinical test (e.g., number of implants for fatigue testing, number of material samples for biocompatibility) are not detailed in this summary but would be part of the full testing reports submitted to the FDA. The tests would have been performed in a laboratory setting, likely in the country of origin of the manufacturer (Turkey) or by contracted testing facilities. These are prospective non-clinical tests.
  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

    • Not applicable. "Ground truth" established by experts is typically for diagnostic devices or AI algorithms that interpret medical data. This submission focuses on the safety and effectiveness of a physical medical device (dental implants and abutments) through non-clinical performance testing against established standards. Device specifications and test methodologies are determined by engineering and scientific standards, not expert interpretation of a "test set" in the context of clinical outcomes.
  3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • Not applicable for a non-clinical device submission. Adjudication methods are used in clinical trials or studies to resolve discrepancies in expert interpretation of data.
  4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • Not applicable. This is a submission for a physical dental implant system, not an AI-assisted diagnostic or therapeutic device that involves human readers.
  5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Not applicable. This device is a physical medical implant, not an algorithm.
  6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • Not applicable in the context of diagnostic "ground truth." For this device, "ground truth" means demonstrating that the physical properties and performance characteristics of the device meet established engineering and biocompatibility standards (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility) and are comparable to predicate devices. This is achieved through objective, quantitative measurements derived from laboratory testing, rather than subjective expert consensus or clinical outcomes data for a "ground truth" label.
  7. The sample size for the training set:

    • Not applicable. This is not an AI/machine learning device that requires a training set.
  8. How the ground truth for the training set was established:

    • Not applicable. This is not an AI/machine learning device.

§ 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.