GENESIS IMPLANT SYSTEM

K101545 · Keystone Dental · DZE · Oct 28, 2010 · Dental

Device Facts

• Record ID: K101545
• Device Name: GENESIS IMPLANT SYSTEM
• Applicant: Keystone Dental
• Product Code: DZE · Dental
• Decision Date: Oct 28, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Genesis Implant System is intended for use in single-stage or two-stage surgical procedures in all types of bone in partially or fully edentulous mandibles and maxillae. The Genesis Implant System supports single or multiple-unit restorations to re-establish patient chewing function and esthetics. Genesis implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established and appropriate occlusal loading is applied.

Device Story

Genesis Implant System comprises endosseous dental implants and associated surgical/restorative components. Implants serve as replacement tooth roots providing foundation for restorations. Used in single-stage or two-stage surgical procedures by dental professionals. Implants feature tapered or straight cylindrical designs with internal indexing connections. Surface treatments include BioSpark (hydrophilic, calcium/phosphorous-enriched nano-topography) to promote osseointegration and AnaTite (pink-colored anodization) on collars/abutments for gingival esthetics. System supports immediate function if primary stability is achieved. Clinical benefit includes re-establishment of chewing function and esthetics.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing (fatigue testing per ISO 14801), in vitro studies (cell metabolic activity, osteoblast proliferation, fibronectin absorption), and in vivo animal studies (sheep model, BIC analysis). BioSpark surface demonstrated hydrophilic properties and enhanced osseointegration markers compared to machined/blasted titanium controls.

Technological Characteristics

Materials: Grade 4 titanium (implants), Grade 5 titanium, gold alloy, PMMA/POM plastic (abutments). Design: Threaded, rootform, tapered/straight cylindrical. Surface: BioSpark (anodic spark deposition, hydrophilic, Ca/P enriched), AnaTite (anodized pink). Connection: TiLobe internal indexing. Sterilization: Gamma radiation. Standards: ISO 14801 (fatigue).

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple-unit dental restorations in the mandible or maxilla. Suitable for placement following natural tooth loss or immediate placement into extraction sockets.

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

• PrimaConnexTM Internal Connection Implant System (K051614)
• Straumann® Dental Implant System (K053088, K061176)
• NanoTiteTM Dental Implants (K062432)
• TiUnite® NobelActiveTM Implants (K050705, K071370)

Submission Summary (Full Text)

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## 510(k) Summary

## OCT 2 8 2010

## Administrative Information

| Manufacturer Name: | Keystone Dental, Inc.<br>144 Middlesex Turnpike<br>Burlington, MA 01803<br>Telephone: [phone]<br>Fax: [phone] |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | John A. Capone, RAC |
| Date Prepared: | October 27, 2010 |
| Device Name and Classification | |
| Trade/Proprietary Name: | Genesis Implant System |
| Common Name: | Dental Implants and Abutments |
| Classification Information: | Endosseous Dental Implant<br>(21 CFR 872.3640), Class II<br>Endosseous Dental Implant Abutment<br>(21 CFR 872.3630), Class II |
| Product Codes | DZE, NHA |

### Device Classification Panel

The Classification Panel for these devices is the Dental Products Panel. Premarket Notifications are reviewed by FDA's Dental Devices Branch.

| Device Name | Manufacturer | 510(k) Number(s) |
|--------------------------------------------------|-----------------|------------------|
| PrimaConnexTM Internal Connection Implant System | Keystone Dental | K051614 |
| Straumann® Dental Implant System | Straumann | K053088, K061176 |
| NanoTiteTM Dental Implants | Biomet 3i | K062432 |
| TiUnite® NobelActiveTM Implants | Nobel Biocare | K050705, K071370 |

## Legally Marketed Devices to Which Equivalence is Claimed (Predicate Devices)

## Device Description

The Genesis Implant System includes implants, and associated surgical, restorative and dental laboratory components. Genesis implants are surgically inserted into the upper and/or lower jawbone and serve as a replacement tooth root, which provides a stable foundation for restorations.

Genesis implants are manufactured from Grade 4 titanium, have a tapered or straight cylindrical design with an internal indexing connection, and are available in various platform diameters and lengths (see table below).

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| Implant Type | Implant Diameter | Implant Lengths |
|------------------|------------------|------------------------------------|
| Straight Implant | 3.8mm | 8.5, 10, 11.5, 13, 14.5, 16 & 18mm |
| | 4.5mm | 8.5, 10, 11.5, 13, 14.5, 16 & 18mm |
| Tapered Implant | 3.8mm | 8.5, 10, 11.5, 13, 14.5, 16 & 18mm |
| | 4.5mm | 8.5, 10, 11.5, 13, 14.5, 16 & 18mm |
| | 5.5mm | 8.5, 10, 11.5, 13, 14.5 & 16mm |
| | 6.5mm | 8.5, 10, 11.5 & 13mm |

The implants have a macro-, micro- and nano-topography and are treated with the BioSpark process, which results in a hydrophilic surface enriched with calcium and phosphorous ions. The implant collar is micro-roughened and treated with the AnaTite" process, which results in a pink color for enhanced esthetics.

The majority of Genesis abutments are manufactured from Grade 5 titanium and are treated with the AnaTite process. Other Genesis abutments are made from Grade 5 titanium/plastic or gold alloy/plastic. Abutments intended for fixed restorations utilize a Grade 5 titanium screw for attachment to the implant. Genesis abutments and associated restorative components are manufactured in a variety of sizes and configurations to be compatible with the implant platforms (see table below).

| Abutment Type | Abutment Material | Abutment Angulations |
|------------------------------|---------------------------|----------------------|
| Healing Abutment | Grade 5 titanium | N/A |
| Temporary Abutment | Plastic (PMMA) | N/A |
| Ti Temporary Abutment | Grade 5 titanium | N/A |
| Esthetic Contour Ti Abutment | Grade 5 titanium | Straight and 15° |
| UCLA Gold/Plastic Sleeve | Gold Alloy/ Plastic (POM) | N/A |
| SureConnect Abutment | Grade 5 titanium | N/A |
| Locator Abutment | Grade 5 titanium | N/A |
| Snap Abutment | Grade 5 titanium | N/A |

## Indications for Use

The Genesis Implant System is intended for use in single-stage or two-stage surgical procedures in all types of bone in partially or fully edentulous mandibles and maxillae. The Genesis Implant System supports single or multiple-unit restorations to re-establish patient chewing function and esthetics. Genesis implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established and appropriate occlusal loading is applied.

## Summary of Technological Characteristics

Predicate devices for the Genesis Implant System were selected based on similar intended use and technological characteristics. All devices are intended for replacing missing teeth and supporting single or multiple-unit restorations in the mandible and/or maxilla. Genesis implants are similar in design and materials to the predicates in that all are threaded, rootform implants.

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#### 510(k) Premarket Notification

Genesis, SLActive and TiUnite implants are all constructed of biocompatible Grade 4 titanium and are sterilized using gamma radiation. Genesis implants are macro- and microroughened as are PrimaConnex, SLActive and TiUnite implants. Genesis implants are further treated with the BioSpark process, which results in a nano-rough topography. NanoTite implants are similar in this regard, as they also feature a nano-rough surface. In addition to the nano-topography, the BioSpark process produces a hydrophilic surface. These surface characteristics are also found on SLActive implants. The BioSpark surface incorporates calcium and phosphorus ions to create an enriched surface, a characteristic shared by NanoTite and TiUnite implants.

Genesis abutments are made from biocompatible materials used in the predicate PrimaConnex, SLActive, NanoTite and TiUnite abutments, including Grade 5 titanium, gold alloy and plastic. The Genesis system has the same implant/abutment TiLobe" internal connection as the PrimaConnex system. Genesis titanium alloy abutments and implant collars receive the AnaTite surface treatment, which produces a pink-colored surface intended to resemble the appearance of gingival tissue. The color is produced by anodization, a common process for treating titanium, which is also used for components of the Straumann and PrimaConnex implant systems.

### Summary of Non-Clinical Testing

The performance of the Genesis Implant System has been demonstrated through non-clinical testing and published literature. The following is a summary of the relevant in vivo and in vitro studies and bench testing.

Genesis implants with angled abutments were fatigue tested in accordance with ISO 14801 and the FDA's Special Controls Guidance on root-form endosseous dental implants and abutments. Genesis instruments, implant threads, and implantation procedures have been designed to optimize insertion torque in order to limit the pressure applied to bone while ensuring good primary stability. In a bench study using simulated bone material, moderate insertion torque was shown when Genesis implants were placed utilizing appropriate surgical instrumentation.

The AnaTite treatment produces a pink coloration on the surface of the Genesis implant collar and abutments. An in vivo study has shown that pink coloration most closely resembles natural gingival tissue.

The BioSpark treatment produces chemical and physical implant surface characteristics that promote osseointegration. These characteristics have been evaluated by various methods. Contact angle (wettability) testing has shown the Genesis implant surface to be hydrophilic. Energy dispersive spectroscopy and sputter mass spectroscopy have confirmed the presence of calcium and phosphorus ions on BioSpark treated surfaces. Mineralization potential of the BioSpark surface has been reported in published literature. Surface roughness at the macro-, micro-, and nano-level has been demonstrated through scanning electron microscopy. These combined characteristics of the BioSpark surface facilitate faster osseointegration, as demonstrated by significant bone-to-implant-contact (BIC) in the cortical bone of sheep at 4 weeks compared to machined or blasted titanium, and as demonstrated by in vitro studies, which vielded the following individual results:

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- Significant increase in cellular metabolic activity over 1 to 7 days in simulated body . fluid on cp-Ti disks treated with BioSpark when compared to machined titanium
- . Significant increase in osteoblast proliferation over 1 to 3 days on cp-Ti disks treated with BioSpark when compared to machined or acid etched titanium
- Early fibronectin absorption and enhanced adhesion, proliferation, and differentiation . of osteoblasts at 24, 48 and 72 hours on cp-Ti disks treated with BioSpark when compared to other anodic spark deposition (ASD) surfaces

Results in animal studies are not necessarily predictive of human clinical results.

## Conclusion

The Genesis Implant System utilizes the same materials and exhibits similar mechanical properties and surface characteristics as the predicate implant systems. The information provided in this 510(k) premarket notification supports the claim of substantial equivalence.

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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 eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

Mr. John A. Capone Director, Regulatory Affairs and Quality Assurance Keystone Dental, Inc. 144 Middlesex Turnpike Burlington, Massachusetts 01803

OCT 2 8 2010

Re: K101545

Trade/Device Name: Genesis Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: October 22, 2010 Received: October 25, 2010

Dear Mr. Capone:

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 preemarket 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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## Page 2 - Mr. Capone

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours,

Wh for

Anthony Watson, B.S., M.S., M.B.A. 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

510(k) Number (if known): K101545

Device Name: Genesis Implant System

#### Indications for Use:

The Genesis Implant System is intended for use in single-stage or two-stage surgical procedures in all types of bone in partially or fully edentulous mandibles and maxillae. The Genesis Implant System supports single or multiple-unit restorations to re-establish patient chewing function and esthetics. Genesis implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established and appropriate occlusal loading is applied.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Susan Kumer

Concurrence of CDRH, Office of Deflivision Bignom (f(ODE)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Numbe