OSSEOFUSE DENTAL IMPLANT SYSTEM

K131748 · Osseofuse, Inc. · DZE · Oct 31, 2013 · Dental

Device Facts

• Record ID: K131748
• Device Name: OSSEOFUSE DENTAL IMPLANT SYSTEM
• Applicant: Osseofuse, Inc.
• Product Code: DZE · Dental
• Decision Date: Oct 31, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OsseoFuse Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Device Story

OsseoFuse Dental Implant System consists of titanium fixtures, abutments, and lab components; surgically placed in maxilla or mandible to replace missing teeth. Fixtures feature internal hexagon connection and RBM (Resorbable Blast Media) surface treatment. System supports one or two-stage surgical procedures with delayed loading. Operated by dental professionals in clinical settings. Device provides structural foundation for prosthetic restorations; enables restoration of masticatory function and aesthetics for edentulous patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Constructed of Ti 6Al 4V ELI (Grade 23) titanium. Features RBM (Resorbable Blast Media) surface treatment. Bone-level implant design with internal hexagon connection. Straight-walled neck with micro-threads. Sterilized via Gamma radiation.

Indications for Use

Indicated for partially or fully edentulous adult patients requiring single or multiple-unit dental restorations, including cemented, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

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

• OsseoFuse Dental Implant System (K110577)

Submission Summary (Full Text)

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# 510(k) Submission

# Osseofuse Dental Implant System

#### 510(K) Summary

#### Submitter

Osseofuse, Inc. Kelvin Yoo 5023 North Parkway Calabasas, Calabasas, CA 91302 Email: [e-mail] Tel. [phone] Fax. [phone]

## Device Information

- Trade Name: OsseoFuse Dental Implant System o
- . Common Name: Endosseous dental implant
- . Classification Name: Implant, Endosseous, Root-Form
- Product Code: DZE ●
- Regulation Number: 872.3640 .
- Device Class: Class II .
- Date prepared: 10/29/2013 .

#### General Description

# The OsseoFuse Dental Implant System includes Hexa-Plus S fixture, Hexa-Plus S abutment, and Hexa-Plus S Lab Components. This system made of Titanium intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. It is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance

Hexa-plus S Fixture is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). Surface of part to be implanted into bone is treated by RBM method .

characteristics. The surface of this system has been treated with R.B.M (Resorbable Blast Media).

The purpose of this submission is

- . to add new fixtures,
- Dia 5.25mm X L 8.5/10/11.5/13mm Dia 6.5mm X L 8.5/10/11.5/13mm Dia 7.5mm X L 8.5/10/11.5/13mm
- to add new abutments. Implant cover screw, wide cover screw, one-step abutment, CCM casting . abutment, and plastic temporary abutment.

**OCT 3 1 2013**

Official Correspondent

325 N. Puente st. Unit B

Phone: [phone] Fax: [phone]

Email: [e-mail]

Kodent Inc. April Lee

Brea, CA 92821

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# Indication for Use

The OsseoFuse Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

# Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

| | Subject Device | Predicate Device |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | N/A | K110577 |
| Device Name | OsseoFuse Dental Implant<br>System | OsseoFuse Dental Implant<br>System |
| Manufacturer | KJ Meditech Co., Ltd. | KJ Meditech Co., Ltd. |
| Indications for Use | Identical to the<br>predicate | Intended for use in partially or<br>fully edentulous mandibles and<br>maxillae, in support of single or<br>multiple-unit restorations<br>including; cement-retained,<br>screw-retained, or overdenture<br>restorations, and terminal or<br>intermediate abutment support<br>for fixed bridgework. |
| Design | Identical to the predicate<br>• Implant Type: Bone Level<br>Implant<br>• Connection Type: Internal<br>Hexagon<br>• Neck Design: Straight walled<br>neck with micro-thread<br>provides crestal seal.<br>• 1mm smooth titanium surface<br>allows soft tissue maintenance.<br>• Body Design: Subject device<br>has one additional cutting edge<br>than predicate device and<br>slightly more aggressive thread<br>design. This change increases | • Implant Type: Bone Level<br>Implant<br>• Connection Type: Internal<br>Hexagon<br>• Neck Design: Straight walled<br>neck with micro-thread<br>provides crestal seal.<br>• 1mm smooth titanium surface<br>allows soft tissue maintenance.<br>• Body Design: Tapered design<br>enables placement near<br>impinging anatomical<br>structures while maximizing<br>prosthetic table diameter for<br>natural emergence profile. |

- Osseofuse Dental Implant System by Osseofuse, Inc. (K110577) .

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| | self-drilling ability of the<br>fixture. Rest of the features are<br>identical to the predicate. | |
|--------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------|
| Appearance | Image: dental implant | Image: dental implant |
| Endosseous Implant<br>Material | Identical to the predicate | Ti 6Al 4V ELI, Gr.23 |
| Surface Treatment | Identical to the predicate | RBM Treatment on the fixture<br>body |
| Implant Sterile | Identical to the predicate | Yes |
| Sterilization Method | Identical to the predicate | Gamma |
| Implant Diameters | 5.25mm, 6.5mm, 7.5mm | 3.75mm, 4.1mm, 4.5mm,<br>5.25mm |
| Implant Lengths | 8.5, 10, 11.5, 13 mm | 8.5 - 16.0 mm |
| Product Code | DZE | DZE |

#### Comparison to Predicate Devices:

The OsseoFuse Dental Implant System has a substantially equivalent intended use as the identified predicate. The OsseoFuse Dental Implant System is similar in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutments, and they are all constructed of titanium.

The subject and predicate device are similar in indications, technology, connection type, surface treatment and functions. The differences between the subject device and the predicate device are the design and the diameters of the fixture.

When compared with predicate device, no new questions of safety or effectiveness have been raised.

There is no difference between the subject and predicate with respect to the indications or technology.

## Non-Clinical Test Data:

Based n a risk analysis of the modifications, no additional testing was added for this submission.

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### Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification concludes that the OsseoFuse Dental Implant System is substantially equivalent to predicate devices as described herein.

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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 consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the emblem.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 31, 2013

OsseoFuse, Incorporated C/O Ms. April Lee Consultant Kodent, Incorporated 325 North Puente Street Unit B BREA CA 92821

Re: K131748

Trade/Device Name: OsseoFuse Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: September 30, 2013 Received: October 2, 2013

Dear Ms. Lee:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

MarySBunner-S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, 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): K131748

Device Name: OsseoFuse Dental Implant System

## Indication for Use:

The OsseoFuse Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter _____________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(Per 21 CFR 801 Subpart C)

(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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