3I DENTAL IMPLANTS

K030614 · Implant Innovations, Inc. · DZE · Sep 15, 2003 · Dental

Device Facts

• Record ID: K030614
• Device Name: 3I DENTAL IMPLANTS
• Applicant: Implant Innovations, Inc.
• Product Code: DZE · Dental
• Decision Date: Sep 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures. In addition, when a minimum of 4 implants, ≥ 10 mm in length, are placed in the the mandible and splinted in the anterior region, immediate loading is indicated.

Device Story

3i Dental Implants are endosseous implants used for prosthetic attachment in the jaw. This submission expands indications to include immediate occlusal loading in the mandible when using at least four splinted implants (≥10mm). The system includes standard abutments and a new single-piece abutment combining screw and abutment. Clinicians perform surgical placement and prosthetic loading. The device provides a stable foundation for dental restorations, benefiting patients by allowing immediate function in specific mandibular cases. Mechanical performance is verified through static compression and cyclic fatigue testing.

Clinical Evidence

Clinical evidence consists of literature reviews and case reports. Studies (e.g., Tarnow et al., Testori et al., Defrancq et al., Ibanez and Jalbout) demonstrate successful osseointegration and clinical outcomes for immediate loading of dental implants in edentulous and partially edentulous patients. Histomorphometric evaluation showed 78%-85% bone-to-implant contact. Success rates reported in literature support the safety and efficacy of the immediate loading indication.

Technological Characteristics

Endosseous dental implants and abutments. Materials are identical to existing 3i systems. Includes standard and new single-piece abutments. Mechanical testing performed per FDA guidance for screw-type endosseous implants. Testing included static load compression, cyclic fatigue, and insertion torque (passed at >5x recommended 20 Ncm).

Indications for Use

Indicated for patients requiring prosthetic attachment in single tooth restorations, partially or fully edentulous spans, freestanding bridges, or overdentures. Immediate loading is indicated for patients with at least 4 implants (≥10mm length) placed and splinted in the anterior mandible.

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

• 3i Dental Implants (K860653, K874590, K935544, K950204, K955428, K972444, K983347, K014235, K022009)
• 3i Abutments/Accessories (K871863, K871954, K891613, K895462, K895463, K904228, K934126, K933969, K933462, K932123, K951553, K022113)
• Nobel Biocare Branemark System Implants (K992937, K022562)
• FRIADENT FRIALIT-2 Implant (K994376)
• Straussman ITI Implant (K984104)
• Dentatus MTI Modular Transitional Implants (K980620)

Submission Summary (Full Text)

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# K030614

# SEP 1 5 2003

## 510(k) Summary

| 510(k)<br>Summary | This summary of 510(k) safety and effectiveness information is being<br>submitted in accordance with the requirements of 21 C.F.R. § 807.92. |
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| Submitter | Implant Innovations, Inc. (3i) |
| Contact<br>Person | Mrs. Jacquelyn A. Hughes, RAC<br>Implant Innovations, Inc.<br>4555 Riverside Drive<br>Palm Beach Gardens, FL 33410<br>[phone]<br>[e-mail] |
| Date Prepared | June 19, 2003 |
| Device Name | 3i Dental Implants |
| Classification<br>Names | Endosseous dental implant |
| Device<br>Classification | Classification: III<br>Classification Panels: Dental<br>Regulation Number: 872.3640 |
| Predicate<br>Device(s) | 3i Dental Implants<br>(K860653, K874590, K935544,K950204, K955428, K972444, K983347,<br>K014235, K022009)<br>3i Abutments/Accessories<br>K871863, K871954, K891613, K895462, K895463, K904228, K934126,<br>K933969, K933462, K932123, K951553, K022113<br>Nobel Biocare Branemark System Implants (K992937, K022562)<br>FRIADENT FRIALIT-2 Implant (K994376)<br>Straussman ITI Implant (K984104)<br>Dentatus MTI Modular Transitional Implants (K980620) |
| Performance<br>Standards | Performance standards have not been established by the FDA under section<br>514 of the Federal, Food, Drug and Cosmetic Act. |

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| Device<br>Description | This 510(k) requests an expansion of the indications for use of all externally<br>and internally hexed 3i dental implants to include immediate loading<br>procedures in the mandible when using a minimum of four (4) splinted<br>implants $≥$ 10mm in length. Standard, commercially available 3i abutments<br>and screws can be used with 3i dental implants in immediate loading<br>procedures. Several new components will complement the standard line for<br>the clinicians use as necessary in immediate occlusal loading. |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | 3i dental implants are intended for surgical placement in the upper or lower<br>jaw to provide a means for prosthetic attachment in single tooth restorations<br>and in partially or fully edentulous spans with multiple single teeth,<br>freestanding bridges and to retain overdentures. |
| | In addition, when a minimum of 4 implants, $≥$ 10 mm in length, are placed in<br>the mandible and splinted in the anterior region, immediate loading is<br>indicated. |
| Technological<br>Characteristics | The proposed 3i implants and accessories are identical to the currently<br>marketed 3i dental implants and accessories and similar in design, materials,<br>and intended use to other legally marketed dental implant systems that are<br>indicated for immediate loading. In addition to the standard 3i abutments, 3i<br>proposes to add a single piece abutment which combines the abutment and<br>screw into a single piece for ease of use. |
| Nonclinical<br>Performance<br>Testing | 3i implants have been mechanically tested consistent with the FDA guidance<br>document Information Necessary for Premarket Notifications Submissions for<br>Screw-Type Endosseous Implants (December 9, 1996). Static Load<br>compression testing was used to simulate biting forces placed upon the<br>implants and Cyclic Fatigue testing simulated the chewing forces placed upon<br>the implants. The new single piece abutment was tested for insertion torque<br>and passed at more than five times the recommended insertion torque of 20<br>Ncm. The single piece abutment was also tested and passed Cyclic Fatigue<br>criteria. Animal studies which proved early loading to be successful for 3i's<br>OSSEOTITE implant systems were submitted in K983347 (cleared September<br>23, 1998). Subsequent data continues to provide evidence of substantial<br>clinical success with early loading. Current practice in the field includes use<br>in a manner described within this 510(k) with clinicians and laboratories<br>working to achieve immediate occlusal loading in edentulous and partially<br>edentulous patients with Types I, II and III bone. |
| Clinical<br>Performance<br>Testing | A current review of the literature suggests clinical success using immediate<br>loading with fully and partially edentulous patients with OSSEOTITE, TPS,<br>Ha-coated, and grit-blasted surfaces when the occlusal load is well-distributed.<br>A few are summarized here and a bibliography may be found in Appendix 3 |

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of the submission.

Tarnow DP,Emtiaz S, Classi A. Immediate loading of threaded implants at stage 1 surgery in edentulous arches: Ten consecutive case reports with 1 to 5 year data.Int. J. Oral Maxillofac Implants 1997; 12:319-324. Tarnow et al report on ten consecutive, edentulous cases comparing the use of implants manufactured by Nobel Biocare (cases 1-3 and 5-7), ITI Straumann (case 4), Astra Tech (cases 8 and 9)and 3i Implant Innovations (case 10). Of 107 implants placed, 104 osseointegrated. For medicolegal reasons, 38 of the implants were submerged and unloaded. The three failed implants occurred in cases 2 and 3, one submerged due to an infection from an adjacent extraction site and two loaded implants due to the cemented provisional restoration being tapped off at 4 months.

Testori T, Szmukler-Moncler s,Francetti L,Del Fabbro M, Scarano A, Piattelli A, Weinstein R Immediate loading of Osseotite implants: A case report and histologic analysis after 4 months of occlusal loading. Int. J. Periodontics Restorative Dent. 2001;21,5:451-459. Testori et al studied 12 Osseotite implants in the mandible of one patient of which 6 were bilaterally splinted and immediately loaded and 6 were left to heal in a submerged manner. Clinical and histologic osseointegration was confirmed for two of the immediately loaded implants by retrieval after 4 months of function. Histomorphometric evaluation revealed 78%-85% bone-to-implant contact, indicating osteogenesis and bone remodeling were not impeded by immediate loading.

Defrancq WD,Luc MDT,Rutten P. Immediate loading: Immediate loading of implants - clinical and technical procedure. Dental Dialogue 2002;2:246-275. Defrancq et al report successful use of an immediate loading technique in 102 procedures for both maxilla and mandible. Of 417 Osseotite implants in 68 mandible procedures only 2 were lost and only 9 of 309 Osseotite implants were lost in 34 maxilla procedures. In ten patients, implants were inserted in both the mandible and maxilla in the surgery for immediate loading.

Ibanez, JC, Jalbout,ZN. Immediate loading of Osseotite implants: Two-year results. Implant Dentristry 2002;11,2:128-134. Ibanez and Jalbout report 100% success in the use of 87 Osseotite implants for immediate loading in eleven patients after two-three years follow-up. Follow-up consisted of both clinical and radiographic examination which found no implant mobility or periimplant radiolucency.

Clincal reports are included in Appendix 3 for reference by Chiapasco et al, Jaffin et al, Schnitman et al, Szmukler-Moncler et al, and Balshi and Wolfinger which discuss the use of immediate loading with various competitive implants to which 32 implants are substantially equivalent in design and materials.

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#### The 3i dental implants and accessories are substantially equivalent to the Conclusion legally marketed 3i dental implant systems, Branemark System (Nobel Biocare), FRIALIT-2, Straumann ITI and Dentatus dental implant systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

SEP 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jacquelyn A. Hughes Director, Regulatory Affairs & Quality Assurance Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K030614

Trade/Device Name: 31 Dental Implants Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: June 19, 2003 Received: June 20, 2003

Dear Ms. Hughes:

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. Hughes

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/dsma/dsmamain.html

Sincerely yours.

Susan Runner

Susan Runner, DDS, MA Interim 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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## Indications for Use Statement

Page 1 of 1

510(k) Number (if known): K030614 Device Name: 3i Dental Implants

Indications for Use:

3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures.

In addition, when a minimum of 4 implants, ≥ 10 mm in length, are placed in the the mandible and splinted in the anterior region, immediate loading is indicated.

Rein Muly for MSR

Division of Anesthesiolo Infection Control, Denta

510(k) Number.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)