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510(k) Data Aggregation
(199 days)
DIO BIOTITE-H IMPLANT SYSTEM
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 ( |
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