K080126 · Dio Department Dsi, Inc. · DZE · Apr 11, 2008 · Dental
Device Facts
Record ID
K080126
Device Name
DIO PROTEM IMPLANT SYSTEM
Applicant
Dio Department Dsi, Inc.
Product Code
DZE · Dental
Decision Date
Apr 11, 2008
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 872.3640
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The DIO Protem Implant Systems are intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.
Device Story
DIO Protem Implant System comprises titanium alloy endosseous dental implants, superstructures (cemented abutments, ball caps, healing caps), prosthetics, and surgical instruments. Implants feature sandblasted, RBM-treated surfaces; diameters of 2.0/2.5mm; lengths of 8-14mm. System designed for immediate loading in partially or fully edentulous mandibles/maxillae to provide temporary support for provisional prosthetics during permanent implant healing. Clinician-operated in dental clinic setting. Implants are single-use, gamma-sterilized; surgical tools require user sterilization. Output is mechanical support for temporary tooth replacement, maintaining gingival contour, and immediate aesthetic recovery. Benefits include protection of main implants from immediate loading and increased endurance of temporary restorations.
Clinical Evidence
Bench testing only. Laboratory testing conducted to determine device functionality and conformance to design input requirements.
Indicated for patients with partially or fully edentulous mandibles and maxillae requiring temporary support for provisional prosthetic devices during the healing phase of permanent endosseous dental implants.
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.
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# K080126
## Attachment 4.
APR 1 1 2008
# 510(k) Summary
DIO Protem Implant System
| 1. Submitter | DIO Department, DSI, Inc.<br>117 Kyo-Dong, Yangsan-City<br>Kyungnam-Do, 626-210, Korea<br>Phone: 82-55-383-7900<br>Fax : 82-55-363-3404 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| 2. US Agent /<br>Contact Person | Hyungick Kim<br>3540 Wilshire Blvd. #1104 Los Angeles,<br>CA 90010, USA<br>Phone : 213-365-2875, Fax : 213-365-1595 |
| 3. Date Prepared | January 08, 2008 |
| 4. Device Name | DIO PROTEM IMPLANT SYSTEM (2.0/2.5MM) |
| 5. Classification Name | Endosseous Dental Implant System |
| 6. Device Classification | Class II<br>Dental Devices panel<br>Regulation Number: 21 CFR 872.3640 |
| 7. Predicate Devices | DIO Protem Implant System(510(k) No: K06710568) |
| 8. Performance | Laboratory testing was conducted to determine device functionality and<br>conformance to design input requirements. |
| 9. Purpose | The purpose of this 510(k) is to change the some information of prior<br>510(k) submission for the DIO Protem Implant System. |
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#### 10. Device Description
DIO Protem Implant System consists of Protem Implants, Superstructure, Prosthetics and Surgical Instruments.
The Protem Implants is an integrated system of endosseous dental implants which designed to protect main implant from immediate loading during osteointegration period, to increase indurance of temporary tooth and to conduct the immediate functions and immediate recovery of aesthetics of osteoimplanted area. These are made of titanium alloy which have a sandblasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implants which provide the clinician to maintain the patients' gingival contour. The Implants have the diameter(2.0/2.5mm) and length.(8/10/12/14mm).
The superstructures consist of Protem Cemented Abutment, Ball Cap and Healing Cap. The Protem Cemented Abutments are made of titanium and intended for cement-retained restorations where conventional crown & bridge techniques are required. It can be used for single or multiple unit restorations. Ball Cap intended to retain the O-ring inside of the denture. Healing Cap is fixed on the ball type fixture to protect the direct pressure reduce the motion of fixture.
The Prosthetics and Surgical Instruments provide the clinician to choose only those components required for each clinical situation.
The implants are gamma sterilized and intended to single use. And the surgical tools are nongamma sterilized and have to be sterilized by user before using.
#### 11. Packing / Labeling / Product Information
DIO Protem Implant System(2.0/2.5mm) follows the guidance of the 21 CFR 872.3640.
#### 12. Intended Use
The DIO Protem Implant Systems are intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.
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### 13. Substantial Equivalence Comparison
| | Subject Device | Predicate Device |
|-----------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Device Name</b> | DIO Department, DSI, Inc.<br>(DIO Protem Implant System(2.0/2.5mm)) | DIO Department, DSI, Inc.<br>(DIO Protem Implant System)<br>K070568 |
| <b>Intended Use</b> | Identical to predicate devices | The DIO Protem Implant Systems are intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants. |
| <b>Material</b> | Titanium alloy | Titanium alloy |
| <b>Screw Threads</b> | YES | YES |
| <b>Implant Thread<br/>Diameter (mm)</b> | 2.0 and 2.5 | 2.0 and 2.5 |
| <b>Lengths(mm)</b> | 8-14 mm | 8-14 mm |
| <b>Surface Treatment</b> | Sanded | Sanded |
| <b>Sterilized</b> | YES | YES |
## TECHNOLOGICAL CHARACTERISTIC COMPARISON
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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APR 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DIO Department, DSI, Incorporated C/O Mr. Hyungick Kim Manager DIO, USA 3540 Wilshire Boulevard, Suite 1104 Los Angeles, California 90010
Re: K080126
Trade/Device Name: DIO Protem Implant System (2.0/2.5mm) Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 27, 2008 Received: April 3, 2008
Dear Mr. Kim:
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 - Mr. Kim
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Judite Y. Michael Davis.
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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Attachment 2.
# Indication for Use
4080126
**510(K) Number (if known):** ***_***
Device Name: DIO Protem Implant System.(2.0/2.5mm)
Indications For Use:
The DIO Protem Implant Systems are intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.
Kei Maly for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080126.
Over - The-Counter Use AND/OR Prescription Use (Per 21 CFR 801.109) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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