ENDOSSEOUS DENTAL IMPLANT SYSTEM

K070905 · Southern Implants, Inc. · DZE · May 24, 2007 · Dental

Device Facts

Record IDK070905
Device NameENDOSSEOUS DENTAL IMPLANT SYSTEM
ApplicantSouthern Implants, Inc.
Product CodeDZE · Dental
Decision DateMay 24, 2007
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

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 Implant System consists of screw-type endosseous dental implants and abutments. Used by dental clinicians to support fixed or removable dental prostheses. Implants are surgically placed into the upper or lower jaw arches. System supports single tooth, partially edentulous, or full arch restorations. Allows for immediate loading when primary stability is achieved. Restores patient chewing function. Device is purely mechanical; no software or electronic components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Screw-type endosseous dental implants and abutments. Manufactured from ASTM F67-95 Grade III or Grade IV Titanium. Mechanical fixation via surgical implantation into the jaw bone.

Indications for Use

Indicated for patients requiring dental prostheses (single tooth, partially edentulous, or full arch) in the upper or lower jaw. Includes option for immediate loading on single and splinted multiple unit restorations, provided good primary stability and appropriate occlusal loading are achieved.

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

Submission Summary (Full Text)

{0}------------------------------------------------ #### 510(K) PREMARKET NOTIFICATION SUMMARY ### (K070905) Name/Address of Submitter: Southern Implants, Inc. 10355 B Democracy Lane Fairfax, VA 22030 Establishment Registration Number: 3003845138 MAY 2 4 2007 Contact Person: Greta M. Hols Phone: (703) 278-3953 Fax: (703) 278-3954 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. Southern 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 K964220 Steri-Oss Replace Titanium Implant System K023113 Nobel BioCare Replace TiUnite Endosseous Implant K061319 Implant Direct Spectra System (RePlant) Device Description and Intended Use: The NSI Implant System is intended to 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. {1}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized abstract symbol resembling an eagle or bird in flight. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the upper half of the circle. ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Greta M. Hols Southern Implants. Incorporated 10355 B Democracy Lane Fairfax, Virginia 22030 MAY 2 4 2007 Re: 070905 Trade/Device Name: Endosseous Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 26, 2007 Received: April 02, 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. {2}------------------------------------------------ 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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Sofita y. Michau Qud. 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 {3}------------------------------------------------ # 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 inuted.com for Ober 21xed 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 Prescription Use_ OR Over-the-counter Use _ (Per 21 CFR801.109) Kei Mulay for MSR ion of Anesthesiology, General Hospital, cuon Control, Dental Devices *K) Number: K070905 Page 3 of 43
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