(199 days)
The DIO Biotite-H Implant System is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Also, angled abutments on small diameter implants (3.8mm) of the DIO Biotite-H Implant System are intended for the anterior region of the mouth and not intended for the posterior region of the mouth due to possible failure of the implant.
The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosthetic components. The DIO BIOTITE -H Implant System is designed for conventional two-stage procedures for single and multiple unit prosthetics. The DIO Biotite-H Implant System's screw-form dental implant consist of machined titanium. Screw's Diameter: Ø 3.8mm, Ø 4.1mm, Ø 4.5mm, Ø 4.8mm, Ø 5.3mm. Length: 8.0mm, 10.mm, 14.0mm. The implant's raw material is titanium and its alloys for surgical implant applications (as perASTM-F-67, A~STM-F-136). The special implant surface is consists of 100% calcium phosphate(CaHPO42H2O). BioTite-H Implant System is an electrochemically deposited calcium phosphate coating based upon a biomimetic process in which implants are coated in an electrolytic bath with a 15+/- 5um thin bioactive layer of a calcium phosphate composite. Biotite -- H Implant System composed of the two calciumphosphates brushite(>95% )and HA(
Here's an analysis of the provided text regarding the DIO Biotite-H Implant Systems:
Acceptance Criteria and Study for DIO Biotite-H Implant Systems
The provided 510(k) summary for the DIO Biotite-H Implant Systems indicates that the device's performance was evaluated through laboratory testing to determine functionality and conformance to design input requirements. However, the document does not specify quantitative acceptance criteria in the typical sense of performance metrics (e.g., accuracy, sensitivity, specificity, or failure rates). Instead, the primary "acceptance criteria" appear to be focused on demonstrating substantial equivalence to existing predicate devices based on design, materials, and intended use.
The study presented is a substantial equivalence comparison rather than a traditional clinical or performance study with defined numerical acceptance criteria for device efficacy or safety. The document aims to show that the new device is as safe and effective as previously cleared devices.
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, explicit numerical acceptance criteria for performance are not provided. The "reported device performance" is essentially a statement of comparability to the predicate device in several key aspects.
| Feature | Acceptance Criteria (Implied by Predicate - K955428) | Reported Device Performance (DIO Biotite-H Implant System) |
|---|---|---|
| Intended Use | The implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restoration and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. | Identical to predicate devices |
| Material | Commercially pure titanium Gr. 3 and Gr.4 (ASTM-F-67) | Commercially pure titanium GR. 3 and GR.4 (ASTM-F-67) |
| Design | Morse Taper with Thread | Morse Taper with Thread |
| Screw Threads | YES | YES |
| Implant Thread Diameter (mm) | 3.8, 4.5, and 5.3 mm | 3.8, 4.1, 4.5, 4.8 and 5.3 mm |
| Collar Height (mm) | 1.8 | 1.8 |
| Lengths (External) | 8-14 mm | 8-14 mm |
| Surface Treatment | HA Coating | HA Coating (specifically 100% calcium phosphate (CaHPO42H2O), thin bioactive layer of a calcium phosphate composite, composed of brushite (>95%) and HA ( |
§ 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.