ENDOSSEOUS DENTAL IMPLANT SYSTEM

K082651 · Southern Implants, Inc. · DZE · Dec 22, 2008 · Dental

Device Facts

• Record ID: K082651
• Device Name: ENDOSSEOUS DENTAL IMPLANT SYSTEM
• Applicant: Southern Implants, Inc.
• Product Code: DZE · Dental
• Decision Date: Dec 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 24° Co-Axis implant is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. This implant is not intended, nor should it be used, in conjunction with an angled abutment.

Device Story

Endosseous dental implant system (24° Co-Axis) designed for surgical implantation into jaw bone to support dental prostheses. Device provides structural foundation for fixed or removable restorations; enables immediate placement and function when primary stability is achieved. Used by dental surgeons in clinical settings. Output is physical support for prosthetic teeth; aids in restoring chewing function. Device is not compatible with angled abutments.

Clinical Evidence

No clinical studies were conducted or deemed necessary. Evidence consists of bench testing per ISO 14801:2003 (fatigue testing for endosseous dental implants), which demonstrated a stable screw joint at the highest forces tested.

Technological Characteristics

Screw-type endosseous dental implants and abutments manufactured from ASTM F67-95 Grade III or Grade IV titanium. Design includes 24° Co-Axis geometry. Fatigue testing performed per ISO 14801:2003.

Indications for Use

Indicated for patients requiring dental prostheses (single tooth, partially edentulous, or full arch) in upper or lower jaw arches. Supports immediate placement and function for single or splinted restorations given good primary stability and appropriate occlusal loading. Contraindicated for use with angled abutments.

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

• 5.0mm and 6.0mm 12° Co-Axis (K033171)
• 4.0mm 12° Co-Axis (K052490)
• Branemark System Zygomatic Implant (K970499)

Submission Summary (Full Text)

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K082651

## 510(k) Premarket Notification Summary

Name/Address of Submitter: Southern Implants, Inc. 5 Holland, Bldg. 209 Irvine, CA 92618

Establishment Registration Number: 3003845138

DEC 2 2 2008

Contact Person: Greta M. Hols Phone: [phone] x 226 Fax: [phone]

Date Summary Prepared: September 9, 2008

Device Classification Name: Endosseous Implant and Accessories

Device Classification Regulation Number: 21 CFR 872.3640

Device Regulatory Status: Class II Special Controls

Trade Name: Endosseous Dental Implant

- Purpose: 'The purpose of this 510(k) is to include additional implants and accessories in the NSI Hexed and Non-Hexed Endosseous Implant System that did not fall within the size range and design shapes identified in prior 510(k) submissions for our system.
- Performance Standards: FDA has not established a performance standard applicable to endosseous implants and their accessories. The materials in the NSI Hexed Implant System meet applicable voluntary standards, Southern Implants screw-type implants and abutments are manufactured from ASTM F67-95 Grade III or Grade IV titanium.
- Predicate Devices: K033171 5.0mm and .6.0mm 12° Co-Axis K052490 4.0mm 12° Co-Axis K970499 Branemark System Zygomatic Implant
- Device Description and Intended Use: The 24° Co-Axis implant is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

This implant is not intended, nor should it be used, in conjunction with an angled abutment.

- Technological Characteristics: The physical properties and designs of the additional implants and accessories in the NSI Hexed and Non-Hexed Implant System were compared with legally marketed predicate devices. The technological characteristics were comparable.
- Brief Discussion of Clinical Studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission.

Brief Discussion of Engineering Studies: Engineering studies were conducted as per 150 standard 14801:2003 (E) -(Dentistry - Fatigue test for endosseous dental implants). Testing revealed a stable screw joint at the highest forces tested

Conclusions Drawn: The 24° Co-Axis implant and associated components have the same intended use as, and technological characteristics similar to, the legally marketed predicate devices. Any differences in the technological characteristics did not raise new issucs of safety or effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Greta M. Hols Integrations Manager Southern Implants, Incorporated 5 Holland, Building 209 Irvine, California 92618

Re: K082651

> Trade/Device Name: Endosseous Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 9, 2008 Received: December 11, 2008

Dear Ms. Hols:

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.

DEC 22 2008

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Page 2 - Ms. Hols

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Chiu S. Lin, Ph.D.

Chiu S. Lin. Ph. D Division 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

KO 82651 510(k) Number:

Device Name: Endosseous Dental Implant System

Indication for Use: The 24° Co-Axis implant is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

This implant is not intended, nor should it be used, in conjunction with an angled abutment.

## Concurrence of CDRH Office of Device Evaluation

Prescription Use ✗
(Per 21 CFR801.109)
OR
Over-the-counter Use **__**

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: k08265