(261 days)
The HAPTITE Coating Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures and not dedicated for immediate loading. This system is intended for delayed loading.
This product is the operating, dental material as placed dental implant to inner part of maxillary to sustain, maintain prosthetic repair tooth or denture, mainbody (structure of subpart) is made by Titanium (Grade 4), is treated as blasting powder, and RBM at room temperature of CaP type to reduce Bone loss to bottom 1mm of the Machine Collar. Also, screw part of below 1 mm is treated as SHS (Super High Speed) RBM HA (Hydroxyapatite) Coating at room temperature. It is connected to structure of upper part as the type of the internal. HA Thin film coating achieved through the process in which the HA particles impact on the surface of implant with high speed. By passing carrier gas, which comes from nitrogen tank, through the hopper containing HA particles, the HA particle and carrier gas can flow to the vacuum chamber. The vacuum chamber maintaining low pressure thanks to the vacuum pump, enable to spray the HA particles with carrier gas out in high speed(more than 500m/sec) through spray nozzle. As HA particles impact on the surface of implant, it reduced to fragment and those fragment make up thin film coating layer. The implant diameters are 3.7, 4.1, 4.3, 4.8, 5.5, 6.0, 6.5, and 7.0 mm and the implant lengths are 7, 8, 9, 10, 12, 14, and 16mm in this system. The system consists of 2 fixture systems, i-clean fixture and s-clean fixture, and 2 abutment systems i-clean and s-clean abutment. The i-clean abutment system is composed of healing cap, various abutments (solid, excellent solid, octa, synocta, inocta, temporary, healing, o-ring and free), screws (cover screw, closing screw, abutment screw, cvlinder screw), gold UCLA, gold cylinder. The s-clean abutment system is composed of healing cap, various abutments (sole, couple, hex, temporary, o-ring, free, octa, zero margin, freemill, and MOA), and gold cylinder, and various screws (abutment, cylinder). i-Clean Fixture is Non-submerged type, once surgery and safe structure as having 8° from center of connection part. s-Clean Fixture is Submerged type, twice surgery and safe structure as having 11° from center of connection part. The abutment lengths are 7, 8, 9, 10, 11, 12mm, and cuff lengths 0.5, 1, 1.5, 2, 2.5, 3, 3.5. 4. 4.5. 5.5. 7mm. The i-Clean fixture is available with either tapered, straight, or SAVE body designs. The i-Clean tapered fixture is available in diameters of 3.7, 4.1, 4.3, and 4.7mm and each diameter is available in lengths of 8, 10, 12, or 14mm. The i-Clean straight fixture is available in diameters of 4.05, 4.25, and 4.75mm and each diameter is available in lengths of 8, 10, 12, 14, and 16mm. The i-Clean SAVE fixture is available in diameters of 5.5, 6.0, 6.5, and 7.0mm and each diameter is available in lengths of 7, 8, 9, 10, and 12mm. The i-Clean Tapered II design contains a thread design with differs from the i-Clean Tapered fixture design. The i-Clean Tapered II has no 'micro thread' design. The s-Clean fixture is available with either tapered, straight, or SAVE body designs. The s-Clean tapered fixture is available in diameters of 3.7, 4.1, 4.3, and 4.8mm and each diameter is available in lengths of 8, 10, 12, or 14mm. The s-Clean straight fixture is available in diameters of 4.1, 4.3, and 4.75mm and each diameter is available in lengths of 8, 10, 12, 14, and 16mm. The s-Clean SAVE fixture is available in diameters of 5.5. 6.0. 6.5. and 7.0mm and each diameter is available in lengths of 7, 8, 9, 10, and 12mm. The s-Clean Tapered II design contains a thread design with differs from the s-Clean Tapered fixture design. The s-Clean Tapered II has no 'micro thread' design.
Here's an analysis of the provided text regarding the acceptance criteria and study for the HAPTITE Coating Implant System, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than setting novel acceptance criteria for a new device type. Therefore, direct "acceptance criteria" for performance are not explicitly stated as they would be for a truly novel device. Instead, the document compares the subject device's performance against the established performance of its predicate devices to demonstrate equivalence. The "acceptance criteria" are implied to be achieving performance comparable to or exceeding the predicate devices in the listed tests.
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (HAPTITE Coating Implant System) |
|---|---|
| Mechanical Strength (Shear bonding strength) | $\approx$ 37 MPa (compared to predicate's 13 MPa and standard 34.5 MPa) |
| Mechanical Strength (Tensile bonding strength) | $\approx$ 41 MPa (compared to standard 34.5 MPa) |
| Coating Stability (HA Coating Implant Graft Test) | Successfully performed in pig bone |
| Dimensional Accuracy (Gap between fixture and abutment) | Successfully performed |
| Rotational Accuracy (Rotational angle tests) | Successfully performed |
| Surface Characteristics (Roughness, Crystallinity, Porosity, Cross-section, Density, Surface area, CaP ratio) | Successfully performed tests |
| Biocompatibility (Material) | CP. GR.4 ASTM F67 (Identical to predicate) |
| Sterilization Method | Gamma sterilized (Identical to predicate) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- The document does not explicitly state the sample sizes used for each test (e.g., how many implants were tested for shear strength, how many pig bones were used, etc.). This information is typically found in the full test reports, not always in the 510(k) summary.
- Data Provenance:
- The tests were described as "Non-clinical Testing data" and performed by Dentis Co., Ltd. (the manufacturer).
- Country of Origin: South Korea (where Dentis Co., Ltd. is located).
- Retrospective or Prospective: These are laboratory tests and animal models, which are inherently prospective in their design to evaluate specific device properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This information is not applicable to the type of non-clinical, laboratory, and animal model testing described. These tests rely on standardized methods (e.g., ASTM standards) and direct measurements, not expert consensus for "ground truth" in the way clinical studies or diagnostic AI algorithms do. Therefore, no experts were used to establish ground truth in this context.
4. Adjudication Method for the Test Set
- Not applicable. As these are objective, non-clinical tests (e.g., measuring shear strength, evaluating coating uniformity), there is no "adjudication" in the sense of reconciling differing expert opinions. The results are quantitative measurements or direct observations against a standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The device in question is an endosseous dental implant, which is a physical medical device, not a diagnostic imaging AI algorithm that would typically be evaluated with MRMC studies or human-in-the-loop performance studies. The evaluation focuses on the physical and material properties of the implant itself.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. As stated above, this is a physical medical device, not an algorithm. Therefore, "standalone" performance for an algorithm is not relevant here.
7. Type of Ground Truth Used
- The "ground truth" for the non-clinical tests was based on objective measurements, adherence to ASTM standards, and direct observation of physical and material properties. For example:
- Shear and tensile strength: Measured values against established ASTM standards (ASTM F1147, 1044).
- Coating stability: Evaluation of the coating layer after an in-vivo graft test in pig bone.
- Surface characteristics: Objective measurements and analyses of roughness, crystallinity, porosity, etc.
8. Sample Size for the Training Set
- Not applicable. Again, this is a physical medical device, not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
§ 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.