ENDOSSEOUS DENTAL IMPLANT SYSTEM

K070841 · Southern Implants, Inc. · DZE · Jun 21, 2007 · Dental

Device Facts

• Record ID: K070841
• Device Name: ENDOSSEOUS DENTAL IMPLANT SYSTEM
• Applicant: Southern Implants, Inc.
• Product Code: DZE · Dental
• Decision Date: Jun 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The NSI Implant System 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 loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

Device Story

NSI Endosseous Dental Implant System consists of screw-type implants and abutments; implanted into upper or lower jaw arches by dental professionals to support fixed or removable dental prostheses. System provides foundation for single tooth, partially edentulous, or full arch restorations; enables immediate loading when primary stability and occlusal conditions are met. Implants manufactured from ASTM F67-95 Grade III or IV Titanium; surface enhanced via alumina particle blasting. Device restores patient chewing function. Clinical use involves surgical placement in dental clinic setting. Safety validated through fatigue testing per FDA Class II Special Controls guidance; sterilization via Co60 irradiation.

Clinical Evidence

No clinical studies were conducted or deemed necessary for this submission. Evidence is based on bench testing, specifically fatigue testing conducted in accordance with the FDA Class II Special Controls Guidance Document for Root-Form Endosseous Dental Implants and Endosseous Dental Abutments.

Technological Characteristics

Screw-type endosseous dental implants and abutments. Material: ASTM F67-95 Grade III or IV Titanium. Surface modification: Alumina (Al2O3) particle blasting. Sterilization: Co60 irradiation (min 25.0 kGy) per ISO 11737, ISO 13409. Packaging validated per ASTM D 4169-04, ASTM F 88-00, ASTM F 1929-98, and ISO 11607.

Indications for Use

Indicated for patients requiring dental prostheses support in upper or lower jaw arches, including single tooth, partially edentulous, or full arch cases. Allows for immediate loading on single and splinted multiple unit restorations given good primary stability and appropriate occlusal loading.

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

• NSI Hexed and Non-Hexed Implant System (K003620)
• NSI Hexed and Non-Hexed Implant System (K020617)
• NSI Hexed and Non-Hexed Implant System (K033171)
• NSI Hexed and Non-Hexed Implant System (K052490)
• NSI Hexed and Non-Hexed Implant System (K053478)
• NSI Hexed and Non-Hexed Implant System (K061169)

Submission Summary (Full Text)

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K070841

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## 510(K) PREMARKET NOTIFICATION SUMMARY

Name/Address of Submitter: Southern Implants, Inc. 10355 B Democracy Lane Fairfax, VA 22030

JUN 2 1 2007

Establishment Registration Number: 3003845138

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

Date Summary Prepared: March 16, 2007

Device Classification Name: Endosseous Implant and Accessories

Device Classification Regulation Number: 21 CFR 872.3640 and 21 CFR 872.3630

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 Endosseous Implant System that did not fall within the size range and design shapes identified in prior 510(k) submissions.

Performance Standards: FDA has not established a performance standard applicable to endosseous implants and their accessories. The materials in the NSI Implant System meet applicable voluntary standards. Northern Implant's screw-type implants and abutments are manufactured from ASTM F67-95 Grade III or Grade IV Titanium.

| Predicate Devices: | K003620 NSI Hexed and Non-Hexed Implant System |
|--------------------|------------------------------------------------|
| | K020617 NSI Hexed and Non-Hexed Implant System |
| | K033171 NSI Hexed and Non-Hexed Implant System |
| | K052490 NSI Hexed and Non-Hexed Implant System |
| | K053478 NSI Hexed and Non-Hexed Implant System |
| | K061169 NSI Hexed and Non-Hexed Implant System |

Device Description and Intended Use: The NSI Implant System 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 loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

The 4.0 co-axis implant is not intended, nor should it be used, in conjunction with an angled abutment.

Sterilization Methods Used: Sterilization of these implants will be achieved using Co60 irradiation, with a minimum dose of 25.0 kGy (2.5 m rads), creating a Sterility Assurance Level of 10th . Validation of sterilization will be done as specified by the Association for the Advancement of Medical Instrumentation (AAMI). Standards utilized include:

| ISO 11737 | Sterilization of Health Care Products – Requirements for validation and routine control –<br>Radiation sterilization |
|-------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 11737-2 | Sterilization of Medical Devices – Microbial Methods – Part 2: Tests of sterility<br>performed in the validation of a sterilization process |
| ISO 13409 | Sterilization of Health Care Products – Radiation Sterilization – substantiation of 25kGy as |

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K070841
2fz

#### a sterilization dose for small or infrequent production batches.

#### Packaging Validation:

All Southern Implants packaging is validated following these standards:

| ♣ ASTM D 4169-04 | Standard Practice for Performance Testing of Shipping Containers and Systems |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ♦ ASTM F 88-00 | Standard Test Method for Seal strength of Flexible Barrier Materials |
| • ASTM F 1929-98 | Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by<br>Dye Penetration |
| EN 552 | Sterilization of medical devise - Validation and routine control of sterilization by<br>irradiation |
| EN556-1:1997 | Sterilization of medical devices - Requirements for medical devices to be labeled<br>"Sterile" |
| EN 868-1:1997 | Packaging materials and systems for medical devices with are to be sterilized:<br>Part 1 General requirements and test methods |
| EN 868-5:1999 | Packaging materials and systems for medical devices which are to be sterilized –<br>Part 5: Heat and self-sealable pouches and reels of paper and plastic film<br>construction - Requirements and test methods |
| EN 868-9: 2000 | Packaging materials and systems for medical devices which are to be sterilized –<br>Part 9: Uncoated non-woven materials of polyolefines suitable for use as<br>packaging of medical devices which are to be terminally sterilized –<br>Requirements and test methods. |
| EN 868-10:2000 | Packaging materials and systems for medical devices which are to be sterilized –<br>Part 10: Adhesive coated nonwoven material of polyolefines for use in the<br>manufacture of heat sealable pouches, reels and lids - Requirements and test<br>methods |
| ♦ ISO 11607 | Packaging for terminally sterilized medical devices |

Technological Characteristics: The physical properties and designs of the additional implants and accessories in the NSI Endosseous Dental Implant System were compared with legally marketed predicate devices. The technological characteristics were comparable.

Surface Modifications: The surface of our implant is blasted using 100 micron alumina (AI2O3) particles. Alumina is a highly biocompatible material and hence if any particles remain embedded in the surface, they will not pose a complication. The other measure taken to reduce the potential of embeddiment is to blast with relatively low pressure. If the indentations caused are significantly smaller than the size of the blast media, then particles tend to not adhere to the surface. (Our S, = 1.43 microns is a fraction of the particle size of 110 microns).Each and every implant is visually inspected under a microscope after surface enhancement as a matter of manufacturing protocol. In addition to visual inspection, a sample implant is sent for SEM testing four times a year for evaluation of the surface as well.

Brief Discussion of Clinical Studies: Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission.

Brief Discussion of Engineering Studies: Fatigue Testing was conducted per FDA Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Abutments that was issued on May 12, 2004. Modification to the testing protocol was discussed with the FDA prior to conducting the test (Enclosure 8 Appendix B). Testing revealed a stable screw joint at the highest forces tested (Enclosure 8).

Conclusions Drawn: The NSI Endosseous Dental Implant System has 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 issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Greta M. Hols Southern Implants, Incorporated 10355 B Democracy Lane Fairfax, Virginia 22030

JUN 2 1 2007

Re: K070841

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: May 18, 2007 Received: May 21, 2007

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.

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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 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,

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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K070841

INDICATION FOR USE

510(k) Number:

Device Name: Endosseous Dental Implant System

Indication for Use: The NSI Implant System 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 loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

# CONCURRENCE OF CDRH OFFICE OF DEVICE EVALUATION

OR

Prescription Use

Over-the-counter Use _

(Per 21 CFR801.109)

Susan Runne

510(k) Number: k070441

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