EBI INTERNAL IMPLANT SYSTEM

K073116 · Ebi, Inc. · DZE · Feb 28, 2008 · Dental

Device Facts

• Record ID: K073116
• Device Name: EBI INTERNAL IMPLANT SYSTEM
• Applicant: Ebi, Inc.
• Product Code: DZE · Dental
• Decision Date: Feb 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

EBI dental implants are intended for immediate, delayed, or conventional placement in the maxillary and/or Mandibular arches to support crowns, bridges or overdentures in edentulous or partially edentulous patients.

Device Story

EBI Internal Implant system is a threaded, root-form endosseous dental implant; features internal octagon and 8-degree morse taper connection. Implant body manufactured from pure Titanium (ASTM F-67); abutments manufactured from Titanium 6A-4V alloy (ASTM F-136). External surfaces roughened via Resorbable Blasting Media (RBM) to facilitate osseointegration. Self-tapping design allows placement with or without pre-tapping bone. System includes various restorative components: screw-retained/cement-retained abutments, cover screws, healing abutments, and angled abutments. Used by dental clinicians in clinical settings to restore patient dentition; provides structural support for prosthetic crowns, bridges, or overdentures. Benefits include restoration of oral function and aesthetics for patients with missing teeth.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics, materials, and design to legally marketed predicate devices.

Technological Characteristics

Threaded, root-form endosseous implant. Materials: Pure Titanium (ASTM F-67) for implant; Titanium 6A-4V alloy (ASTM F-136) for abutments. Design: Internal octagon, 8-degree morse taper. Surface: Resorbable Blasting Media (RBM). Dimensions: 3.3-4 mm diameter, 6-15 mm length. Sterilization: Gamma radiation.

Indications for Use

Indicated for edentulous or partially edentulous patients requiring dental implants for support of crowns, bridges, or overdentures in the maxillary or mandibular arches; placement may be immediate, delayed, or conventional.

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

• AVANA Dental Implant System (K051576)
• ITI Dental implant system (K003552)

Submission Summary (Full Text)

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K073116

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

| Submitter | EBI Inc.<br>#289, Wuisong-ri, Apryang-myeon<br>Kyeongsan-city, Kyeongsangbook-do<br>712-825, Korea<br>Telephone [phone]<br>Fax: [phone] | | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact | Myung-bae Jegal, Managing Director | | |
| Date Prepared | February 21, 2008 | | |
| Device Name | EBI Internal Implant | | |
| Classification Name | Implant, endosseous, root-form DZE and Abutment implant,<br>dental, endosseous NHA | | |
| Device Classification | Class II<br>Dental Devices Panel<br>21 CFR 872.3640 and 872.3630 | | |
| Predicate Devices | AVANA Dental Implant System K051576<br>ITI Dental implant system K003552 | | |
| Performance | Performance standards have not been established by the FDA<br>under Section 514 of the Federal Food, Drug, and Cosmetic<br>Act. | | |
| Device Description | The EBI Internal Implant system is a threaded, root form<br>endosseous implant comprised of an internal octagon, 8°<br>morse tapered device manufactured from pure Titanium<br>ASTM F-67 and the Abutment from Titanium 6A-4V alloy E 11<br>-ASTM 136. The implant's external threaded surfaces are<br>roughened to facilitate tissue and bone integration. The<br>implant's self-tapping feature may be used with or without<br>pre-tapping the bone. System components for restorative<br>purposes include: screw retained and cement retained<br>abutments, cover screws, healing abutments, and angled<br>abutments. | | |
| Indications for Use | EBI dental implants are intended for immediate, delayed, or<br>conventional placement in the maxillary and/or Mandibular<br>arches to support crowns, bridges or overdentures in<br>edentulous or partially edentulous patients. | | |

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K07311

## Technical Characteristics

| | | Predicate Devices | | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Characteristics | EBI Internal Implant<br>System | AVANA Dental<br>Implant<br>K051576<br>OSSTEM Co., Ltd. | ITI Dental<br>Implant<br>K003552<br>Institut Straumann<br>AG | |
| 510(k) | - | | | |
| Material<br>composition | Implant: Pure Titanium<br>Abutment: Ti Alloy | Implant: Pure<br>Titanium<br>Abutment: Ti Alloy | Implant: Pure<br>Titanium<br>Abutment: Ti Alloy | |
| Design | Internal Morse Taper,<br>Internal Octagon | Internal Connection<br>Morse Taper, Internal<br>Octagon | Internal Connection<br>Morse Taper,<br>Internal Octagon | |
| Implant<br>Diameter | 3.3-4 mm | 4.1-4.8 mm | 3.3 - 4 mm | |
| Implant Length | 6-15 mm | 8.4-15 mm | 6 - 14mm | |
| Sterilization<br>Method | Gamma | Gamma | Gamma | |
| Indications for<br>use | Intended for immediate<br>delayed or conventional<br>placement in the<br>maxillary and/or<br>Mandibular arches to<br>support crowns, bridges,<br>or overdentures in<br>edentulous or partially<br>edentulous patients. | Intended for use in<br>partially or fully<br>edentulous mandibles<br>and maxillae, in support<br>of single or multiple-<br>unit restorations<br>including cement<br>retained, screw<br>retained, or<br>overdenture<br>restorations, and<br>terminal or<br>intermediate abutment<br>support of fixed<br>bridgework. | Intended for<br>immediate, delayed,<br>or conventional<br>placement in the<br>maxillary and/or<br>Mandibular arches to<br>support crowns,<br>bridges or<br>overdentures in<br>edentulous or<br>partially edentulous<br>patients. | |
| Surface<br>treatment | Resorbable Blasting<br>media (RBM) | Resorbable Blasting<br>media (RBM) | Resorbable Blasting<br>media (RBM) | |

Conclusion: In all respects, the EBI Internal Implants components are the equivalent of currently marked devices. They are made of the same materials and have similar dimensions and characteristics. This device is substantially equivalent in design, material, intended use and function to the products listed in the table above.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem.

FEB 28 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EBI, Incorporated C/O Mr. Daniel Kamm Principal Consultant Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K073116

Trade/Device Name: EBI Internal Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: DZE, NHA Dated: February 21, 2008 Received: February 25, 2008

Dear Mr. Kamm:

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. Kamm

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,

Syrite H. Michie Omd.

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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K073116

## Indications for Use

510(k) Number (if known): K07

Device Name: EBI Internal Implant System

Indications For Use: Intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges or overdentures in edentulous or partially edentulous patients.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

SumRennes

Division Sign-Off) livision of Anesthesiology, General Hospital fection Control, Dental Devices

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:0(k) Number: K073114