(199 days)
Not Found
No
The summary describes a dental implant system made of titanium and calcium phosphate, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an endosseous dental implant system used for surgical placement in the jaw arches to restore chewing function, which classifies it as a therapeutic device.
No
The device is described as an endosseous dental implant system used for surgical placement to restore chewing function, indicating it is a therapeutic device rather than a diagnostic one. It does not mention any function related to diagnosing a condition or disease.
No
The device description explicitly states it is comprised of physical components like dental implants, surgical instruments, and prosthetic components made of titanium and calcium phosphate. It is a hardware-based medical device.
Based on the provided information, the DIO Biotite-H Implant System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for surgical placement in the jaw to provide a root form for prosthetic appliance attachment to restore chewing function. This is a surgical and restorative procedure performed directly on the patient's body.
- Device Description: The device is comprised of dental implants, surgical instruments, and prosthetic components. These are all physical devices used in a surgical setting.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The DIO Biotite-H Implant System does not perform any such examination of bodily specimens.
Therefore, the DIO Biotite-H Implant System is a medical device used for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DZE, NHA
Device Description
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(
§ 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
K073070
510(K) SUMMARY DIO Biotite-H Implant Systems
MAY 1 6 2008
.
:
| MAY 16 2008 | |
|---|---|
| 15-1. Submitter | DIO Department, DSI, Inc. |
| 117 Kyo-Dong, Yangsan-City | |
| Kyungnam-Do, 626-210, South Korea | |
| Phone: 82-55-363-3401 | |
| Fax : 82-55-363-3404 | |
| 15-2. US Agent / | |
| Contact Person | PhD. Steve Chang |
| 13340 E. Firestone Blvd. Suite J | |
| Santa Fe Springs, CA 90670 | |
| Phone : 562-404-8466, Fax : 562-404-2757 | |
| 15-3. Date Prepared | October 26, 2007 |
| 15-4. Device Name | DIO BIOTITE-H IMPLANT SYSTEMS |
| 15-5. Classification Name | Endosseous Dental Implant System |
| 15-6. Device Classification | Class II |
| Dental Devices panel | |
| 21 CFR § 872.3640 | |
| Regulation Number: | |
| 15-7. Predicate Devices | IMPLANT INOVATION, INC. (K 955428) |
| 15-8. Performance | Laboratory testing was conducted to determine device functionality |
| and conformance to design input requirements. |
:
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1
15-9. Device Description
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(