DIO BIOTITE-H IMPLANT SYSTEM

K073070 · Dio Department Dsi, Inc. · DZE · May 16, 2008 · Dental

Device Facts

• Record ID: K073070
• Device Name: DIO BIOTITE-H IMPLANT SYSTEM
• Applicant: Dio Department Dsi, Inc.
• Product Code: DZE · Dental
• Decision Date: May 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Endosseous dental implant system; screw-form design; used for single or multiple unit prosthetic attachment in upper/lower jaw. Implant consists of machined titanium (ASTM F-67, F-136) with electrochemically deposited calcium phosphate coating (brushite >95%, HA <5%). Surgical placement performed by dental professionals. System includes implants, surgical instruments, and prosthetic components. Provides root-form foundation for fixed or removable prosthetics; restores patient chewing function. Angled abutments on 3.8mm implants limited to anterior region to prevent mechanical failure.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Commercially pure titanium Gr 3 and Gr 4 (ASTM F-67, ASTM F-136). Surface: 15+/- 5um calcium phosphate coating (brushite >95%, HA <5%) via electrochemical deposition. Design: Screw-form, Morse taper. Diameters: 3.8mm to 5.3mm. Lengths: 8mm to 14mm. Sterilization: Gamma radiation.

Indications for Use

Indicated for patients requiring single or multiple unit prosthetic restoration in the upper or lower jaw arches to restore chewing function. Angled abutments on 3.8mm diameter implants are restricted to the anterior region of the mouth.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• IMPLANT INOVATION, INC. (K955428)

Reference Devices

• OsteoGraft/D-700 (K940348)
• alcitie (K882682)
• Osteograf AR Alveolar Ridge Hydroxylapatite 18-40 (K852742)
• HA-2000 (K852765)
• Perioglas-BioGlass Bone Graft Particulate (K992416)
• Novabone-Bioglass Bone Graft Particulate (K000149)
• Biogran Bioactive Glass Synthetic Bone Graft Material (K952922)
• PermanMesh Hydroxylapatite Matrix (K921468)
• Osteograf/AR+Permaridge Hydroxylapatite, 18-40 (K862061)
• HAPSET Hydroxylapatite Bone Graft Plaster (K910432)

Submission Summary (Full Text)

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# K073070

# 510(K) SUMMARY DIO Biotite-H Implant Systems

# MAY 1 6 2008

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:

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| | MAY 16 2008 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 15-1. Submitter | DIO Department, DSI, Inc.<br>117 Kyo-Dong, Yangsan-City<br>Kyungnam-Do, 626-210, South Korea<br>Phone: [phone]<br>Fax : [phone] |
| 15-2. US Agent /<br>Contact Person | PhD. Steve Chang<br>13340 E. Firestone Blvd. Suite J<br>Santa Fe Springs, CA 90670<br>Phone : [phone], Fax : [phone] |
| 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<br>Dental Devices panel<br>21 CFR § 872.3640<br>Regulation Number: |
| 15-7. Predicate Devices | IMPLANT INOVATION, INC. (K 955428) |
| 15-8. Performance | Laboratory testing was conducted to determine device functionality<br>and conformance to design input requirements. |

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1. 1. 1

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#### 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(<5%).

#### 15-10. Packing / Labeling / Product Information

In a clean room that is Class 10,000 or less, put the product into a capsule, and then put the capsule in a pet container, which is 45mm by 75mm, then sealed the pet container with PERFECSEAL CR27 1073B Coated Tyvek®. DIO Biotite-H Implant Systems DIO Biotite -H Implant Fixtures will be packaged.

#### 15-11. Intended 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 mount due to possible failure of the implant.

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## 15-12. Substantial Equivalence Comparison

.

The following are the predicate devices that are substantially equivalent to the Calcium Hydroxylapatite Implant:

| K955428 | Implant Innovation, Inc. |
|---------|-----------------------------------------------------------------------|
| | 3i Hydroxylapatite Coated Standard Thread |
| K940348 | OsteoGraft/D-700 |
| | CeraMed Corporation. 12860 West cedar Drive. Lakewood, Co 80228 |
| K882682 | alcitie |
| | Calcitek, Inc., 4125-B Sorrento Valley Boulevard, San Diego, CA 92121 |
| K852742 | Osteograf AR Alveolar Ridge Hydroxylapatite 18-40 |
| | Coors Biomedical Company, 12860 West Cedar Drive, |
| | Lakewood, CO 80228 |
| K852765 | HA-2000 |
| | Orthomatrix, Inc., 6968 Sierra Court, Dublin CA 94568 |
| K992416 | Perioglas-BioGlass Bone Graft Particulate |
| | U.S. Biomaterials Corp., One Progress Boulevard, Alachua, |
| | FL 32615 |
| K000149 | Novabone-Bioglass Bone Graft Particulate |
| | U.S. Biomaterials Corp., One Progress Boulevard, Alachua, |
| | FL 32615 |
| K952922 | Biogran Bioactive Glass Synthetic Bone Graft Material |
| | Orthovita Co., 212 Carnegie Center Drive, Suite 206, |
| | Princeton, NJ 08540 |
| K921468 | PermanMesh Hydroxylapatite Matrix |
| | CeraMed Corp., 12860 West Cedar Drive, Lakewood, CO 80228 |
| K862061 | Osteograf/AR+Permaridge Hydroxylapatite, 18-40 |
| | Coors Biomedical Company, 12860 West Cedar Drive, Lakewood, CO 80228 |
| K910432 | HAPSET Hydroxylapatite Bone Graft Plaster |
| | Lifecore Biomedical, Inc., 1050 Connecticut Avenue, N.W. |
| | Washington Square, Suite 1100, Washington, D.C. 20036 |

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The Biotite-H Implant is substantially equivalent to the predicate device sited above.

| | Subject Device | Predicate Device |
|---------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | DIO DENTAL IMPLANT CO. LTD<br>(DIO Biotite-H Implant System) | IMPLANT INOVATION, INC.<br>(K 955428) |
| Intended Use | Identical to predicate devices | The implants are<br>indicated for surgical placement in<br>the upper or lower jaw<br>to provide a means for prosthetic<br>attachment in single tooth<br>restoration and in partially or fully<br>edentulous spans with<br>multiple single teeth, or as a<br>terminal or intermediary<br>abutment for fixed or removable<br>bridgework, and to retain<br>overdentures. |
| Material | Commercially pure titanium GR. 3<br>and GR.4 (ASTM-F-67) | Commercially pure titanium Gr. 3 and<br>Gr.4 (ASTM-F-67) |
| Design | Morse Taper with Thread | Morse Taper with Thread |
| Screw Threads | YES | YES |
| Implant Thread<br>Diameter (mm) | 3.8, 4.1, 4.5, 4.8 and 5.3 mm | 3.8, 4.5, 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 |
| Gamma sterilized | YES | YES |

# TECHNOLOGICAL CHARACTERISTIC COMPARISON

## Attachments

| Screw-retained restoration system | YES | YES |
|----------------------------------------|-----|-----|
| Cemented restoration system | YES | YES |
| Overdenture restoration | YES | YES |
| Instruments (surgical and restorative) | YES | YES |

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR & 807.93

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scan or photocopy.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DIO Department, DSI, Incorporated C/O Dr. Steve Chang Kodent, Incorporated 13340 East Firestone Boulevard, Suite J Santa Fe Springs, California 90670

MAY 1 6 2008

Re: K073070

Trade/Device Name: DIO Biotite-H Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: May 14, 2008 Received: May 16, 2008

Dear Dr. Chang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Chang

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chorts

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(K) Number (if known):

Device Name: DIO Biotite-H Implant System

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.

Kim Muly for MSR

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: KD73070

Prescription Use
(Part 21 CFR 801 Subpart D)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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