External Hex Implants

K163634 · Southern Implants (Pty), Ltd. · DZE · Nov 6, 2017 · Dental

Device Facts

• Record ID: K163634
• Device Name: External Hex Implants
• Applicant: Southern Implants (Pty), Ltd.
• Product Code: DZE · Dental
• Decision Date: Nov 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Southern Implants' External Hex Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. Southern Implants' External Hex Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

Device Story

External Hex Implants are endosseous dental implants; used for prosthetic attachment of crowns, bridges, or overdentures. Device lines include External Hex Tapered, Tapered Internal Drive, Cylindrical Internal Drive, and Co-Axis Tapered implants. Implants feature grit-blasted surfaces; some include machined coronal portions. Co-Axis models feature angled coronal portions. Implants are surgically placed in the maxilla or mandible by a clinician. The device provides a foundation for prosthetic restoration; immediate loading is permitted when primary stability is achieved. Benefits include restoration of chewing function and support for dental prostheses. The system includes various abutments (cover screws, healing caps, titanium, anatomic, cosmetic, gold, chrome-cobalt, compact conical, passive) for cement-retained or screw-retained restorations. The device is used in a clinical setting.

Clinical Evidence

Bench testing only. Evidence includes radiation sterilization validation (ISO 11137-1/2), steam sterilization validation (ISO 17665-1/2), shelf-life testing (ISO 11607-1/2, ASTM F88, F1929, F1980), bacterial endotoxin testing (AAMI/ANSI ST 72), biocompatibility testing (ISO 10993-5), and mechanical testing (ISO 14801) to demonstrate structural integrity.

Technological Characteristics

Materials: Unalloyed titanium (ASTM F67), titanium alloy (ASTM F136), gold alloy, cobalt-chromium alloy (ASTM F1537, F1562). Design: Threaded, grit-blasted surface, external hex connection. Dimensions: Diameters 3.25-6.0mm, lengths 6-20mm. Sterilization: Irradiation or steam. Connectivity: None (mechanical).

Indications for Use

Indicated for surgical placement in the upper or lower jaw for prosthetic attachment of crowns, bridges, or overdentures in patients requiring dental restoration, including immediate function when primary stability and 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

• 3i T3 External Hex Dental implants (K133049)
• Endosseous implant and accessories (NSI Hexed and Non-Hexed Implant System) (K003620)
• Endosseous implant and accessories (NSI Hexed and Non-Hexed Implant System) (K020617)
• Endosseous implant and accessories (K082651)
• Endosseous implant and accessories (K053478)
• Endosseous implant and accessories (K070841)
• Endosseous implant and accessories (K070905)
• Low Profile Abutment (K092341)
• VARIOunite (K160244)
• Neoss TiBase and CoCr Abutments (K150669)
• OsseoSpeed™ Plus (K120414)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right.

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

November 6, 2017

Southern Implants (Pty) Ltd. % Linda Schulz Senior Regulatory Affairs Specialist PaxMed International, LLC 12264 El Camino Real Suite 400 San Diego, California 92130

Re: K163634

Trade/Device Name: External Hex Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: October 23, 2017 Received: October 24, 2017

Dear Linda Schulz:

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. 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.

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

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Mary S. Runner -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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)

K163634

Device Name

External Hex Implants

Indications for Use (Describe)

Southern Implants' External Hex Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.

Southern Implants' External Hex Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) Summary

## K163634

## External Hex Implants

# Southern Implants (Pty) Ltd.

November 6, 2017

| ADMINISTRATIVE INFORMATION | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer Name | Southern Implants (Pty) Ltd.<br>1 Albert Road<br>Irene, South Africa 0062<br>Telephone: [phone]<br>Fax: [phone] |
| Official Contact | Lauranda Breytenbach<br>Regulatory Affairs and Quality |
| Representative/Consultant | Linda K. Schulz, BSDH, RDH<br>Floyd G. Larson, MS, MBA<br>PaxMed International, LLC<br>12264 El Camino Real, Suite 400<br>San Diego, CA 92130<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>[e-mail] |

## DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name | External Hex Implants |
|------------------------------------------|----------------------------------------------------------------------|
| Common Name | Dental implant<br>Dental implant abutment |
| Classification Name | Implant, endosseous, root form<br>Endosseous dental implant abutment |
| Classification Regulations | 21 CFR 872.3640, Class II |
| Product Code | DZE, NHA |
| Classification Panel<br>Reviewing Branch | Dental Products Panel<br>Dental Devices Branch |

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| Primary Predicate | Device Name | K Number |
|-------------------------|-----------------------------------------------------------------------------|----------|
| Biomet 3i (Primary) | 3i T3 External Hex Dental implants | K133049 |
| Reference Predicates | | |
| NSI Inc | Endosseous implant and accessories (NSI Hexed and Non-Hexed Implant System) | K003620 |
| NSI Inc | Endosseous implant and accessories (NSI Hexed and Non-Hexed Implant System) | K020617 |
| Southern Implants Inc. | Endosseous implant and accessories | K082651 |
| Northern Implants, LLC | Endosseous implant and accessories | K053478 |
| Southern Implants Inc. | Endosseous implant and accessories | K070841 |
| Southern Implants Inc. | Endosseous implant and accessories | K070905 |
| Biomet 3i | Low Profile Abutment | K092341 |
| Thommen Medical AG | VARIOunite | K160244 |
| Neoss, Ltd. | Neoss TiBase and CoCr Abutments | K150669 |
| AstraTech AB [Dentsply] | OsseoSpeed™ Plus | K120414 |

#### PREDICATE DEVICE INFORMATION

#### INDICATIONS FOR USE

Southern Implants' External Hex Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.

Southern Implants' External Hex Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

#### SUBJECT DEVICE DESCRIPTION

The subject device consists of four product lines, External Hex Tapered Implants, External Hex Tapered Internal Drive Implants, External Hex Cylindrical Internal Drive Implants, and External Hex Co-Axis Tapered Implants. Internal drive implants are inserted with a removable tool as opposed to a fixture mount. All product line implants have an external hex implant/abutment connection and a grit-blasted surface. External Hex Tapered Implants and CoAxis Implants come in an MSC design with a machined coronal portion. One product line implant, Co-Axis Tapered, has an angled coronal portion.

| Implant Line | Diameter (mm) | Length (mm) | Implant Angle |
|-----------------------------------|---------------|----------------------------------|---------------|
| Ex Hex Tapered | 3.25 | 8.5, 10, 11.5, 13, 15, 18 | NA |
| Ex Hex Tapered | 4.0 | 6, 8.5, 10, 11.5, 13, 15, 18 | NA |
| Ex Hex Tapered | 5.0 | 6, 8.5, 10, 11.5, 13, 15, 18 | NA |
| Ex Hex Tapered - MSC | 3.25 | 8.5, 10, 11.5, 13, 15, 18 | NA |
| Ex Hex Tapered - MSC | 4.0 | 6, 8.5, 10, 11.5, 13, 15 | NA |
| Ex Hex Tapered - MSC | 5.0 | 6, 8.5, 10, 11.5, 13, 15 | NA |
| Ex Hex Tapered Internal Drive | 4.0 | 8.5, 10, 11.5, 13, 15, 18 | NA |
| Ex Hex Tapered Internal Drive | 4.7 | 10, 11.5, 13, 15, 18 | NA |
| Ex Hex Tapered Internal Drive | 5.7 | 10, 11.5, 13, 15, 18 | NA |
| Ex Hex Cylindrical Internal Drive | 3.75 | 7, 8.5, 10, 11.5, 13, 15, 18, 20 | NA |
| Ex Hex Cylindrical Internal Drive | 5.0 | 6, 7, 8.5, 10, 11.5, 13, 15, 18 | NA |
| Ex Hex Cylindrical Internal Drive | 6.0 | 7, 8.5, 10, 11.5, 13, 15 | NA |
| Ex Hex CoAxis Tapered | 3.25 | 8.5, 10, 11.5, 13, 15, 18 | 12° |
| Ex Hex CoAxis Tapered | 4.0 | 8.5, 10, 11.5, 13, 15, 18 | 12° |
| Ex Hex CoAxis Tapered | 4.0 | 8.5, 10, 11.5, 13, 15, 18, 20 | 24° |
| Ex Hex CoAxis Tapered | 4.7 | 8.5, 10, 11.5, 13, 15, 18 | 12° |
| Ex Hex CoAxis Tapered | 4.7 | 8.5, 10, 11.5, 13, 15, 18 | 24° |
| Ex Hex CoAxis Tapered - MSC | 3.25 | 8.5, 10, 11.5, 13, 15, 18 | 12° |
| Ex Hex CoAxis Tapered - MSC | 4.0 | 8.5, 10, 11.5, 13, 15, 18 | 12°, 24° |
| Ex Hex CoAxis Tapered - MSC | 4.7 | 8.5, 10, 11.5, 13, 15, 18 | 12°, 24° |

Implants are available in the following diameters and lengths

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Each product line includes corresponding abutments in multiple designs (Cover Screws, Healing Caps, Healing Abutments, Titanium Abutments, Anatomic Abutments, Cosmetic Abutments, Gold Abutments, Chrome Cobalt Abutments, Compact Conical Abutments, Passive Abutments) for cement-retained and screw-retained restorations. All retaining screws compatible with the subject device have been previously cleared in K053478. Retaining screws TSHZ3 and TSH1 were used for mechanical testing according to ISO 14801. Compact Conical Abutments and Chrome Cobalt Abutments are designed for multi-unit restorations. Compact Conical Abutment is available in straight, 17°, and 30° designs. Cosmetic abutments are available in 12° and 24°. All other abutments are straight (0°). Subject Device components are made of unalloyed titanium, titanium alloy, gold alloy, or cobalt-chromium alloy. Material standards for the subject device components are ASTM F67, ASTM F136, ASTM 1537, and ASTM F1562. Small diameter implants and angled abutments are not recommended for the posterior region

| Abutment Model | Abutment Connection Platform | Diameters (mm) | Angulation | Height (mm) |
|------------------------------|------------------------------------------------------------|----------------|------------|------------------------|
| Cover screws | External Hex | 3.5, 5.0 | 0 | 4.4, 4.35 |
| | External Hex | 5.0 | 0 | 4.35 |
| Healing Caps | Compact Conical | 4.8 | 0 | 4.6, 6.2 |
| | Compact Conical | 6.0 | 0 | 4.6, 6.2 |
| | Compact Conical | 7.0 | 0 | 4.6, 6.2 |
| | Compact Conical | 9.0 | 0 | 4.6, 6.2 |
| Healing abutments | External Hex | 4.5 | 0 | 2.2, 3, 4, 5, 6, 8 |
| | External Hex | 5.5 | | 2.2, 3, 4, 5, 6, 8, 12 |
| | External Hex | 6.5 | 0 | 2.2, 3, 4, 5, 6, 8, 12 |
| | External Hex | 7.5 | | 2.2, 3, 4, 5, 6, 8, 12 |
| Titanium Abutments | External Hex; Engaging and non-engaging | 5.0 | 0 | 1, 5 |
| | External Hex; Engaging and non-engaging | 6.0 | 0 | 1, 5 |
| Anatomic Abutments | External Hex; Engaging and non-engaging | 3.4 | 0 | 2, 3, 5 |
| | External Hex; Engaging and non-engaging | 3.43 | 0 | 2, 3, 5 |
| | External Hex; Engaging and non-engaging | 4.05 | 0 | 2, 3, 5 |
| | External Hex; Engaging and non-engaging | 5.0 | 0 | 2, 3, 5 |
| | External Hex; Engaging and non-engaging | 6.0 | 0 | 2, 3, 5 |
| Cosmetic Abutments | External Hex; Engaging | 3.43 | 12°, 24° | 2.9, 3.5 |
| | External Hex; Engaging | 4.05 | 12°, 24° | 3.0 |
| | External Hex; Engaging | 5.0 | 12°, 24° | 2.0, 2.6 |
| | External Hex; Engaging | 6.0 | 12°, 24° | 2.6 |
| Gold Abutments | External Hex; Compact Conical<br>Engaging and non-engaging | 4.05 | 0 | 0.5 |
| | External Hex; Compact Conical<br>Engaging and non-engaging | 5.0 | 0 | 0.5 |
| | External Hex; Compact Conical<br>Engaging and non-engaging | 6.0 | 0 | 0.5 |
| Chrome Cobalt<br>Abutments | External Hex; Non-engaging | 3.40 | 0 | 1.5 |
| | External Hex; Non-engaging | 4.05 | 0 | 1.5 |
| Compact Conical<br>Abutments | External Hex; Engaging (angled)<br>Non-engaging (straight) | 3.0 | 0 | 2, 3, 4, 5 |
| | External Hex<br>Engaging (angled) Non-engaging (straight) | 3.43 | 17° | 3.0 |
| | External Hex<br>Engaging (angled) Non-engaging (straight) | 4.05 | 17° | 2.9, 3.9 |
| | External Hex<br>Engaging (angled) Non-engaging (straight) | 4.05 | | 4, 5, 6, |
| | External Hex<br>Engaging (angled) Non-engaging (straight) | 5.0 | 30° | |
| | External Hex<br>Engaging (angled) Non-engaging (straight) | 5.0 | 0° | 1.58, 2, 3, 4, 5.5 |
| | External Hex<br>Engaging (angled) Non-engaging (straight) | 5.0 | 17° | 2.9, 3.9 |
| | | | | |
| | External Hex | 5.0 | 30° | 4, 5, 6, |
| | Engaging (angled) Non-engaging (straight) | | | |
| | External Hex | 6.0 | 0° | 1.58, 2, 3, 4, 5.5 |
| | Engaging (angled) Non-engaging (straight) | | | |
| | External Hex | 6.0 | 17° | 308, 4.08 |
| | Engaging (angled) Non-engaging (straight) | | | |
| | External Hex | 6.0 | 30° | 4.3, 5.3, 6.3 |
| | Engaging (angled) Non-engaging (straight) | | | |
| Passive Abutments | External Hex | 6.0 | 0 | 0.4 - 0.6 |
| | Compact Conical | | | |

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## PERFORMANCE DATA

Non-clinical testing data submitted or relied upon to demonstrate substantial equivalence included: radiation sterilization validation according to ISO 11137-1 and 11137-2 and steam sterilization according to ISO 17665-1 and ISO 17665-2, demonstrating a sterility assurance level (SAL) of 10-6; Shelf life testing according to ISO, 11607-1, ISO 11607-2, ASTM F88, ASTM 1929, and ASTM 1980; bacterial endotoxin testing to AAMI/ANSI ST 72, demonstrating acceptable endotoxin limits; biocompatibility testing according to ISO 10993-5 (cytotoxicity), demonstrating acceptable biocompatibility; and mechanical testing according to ISO 14801, demonstrating that the subject device is strong enough for its intended use.

## EQUIVALENCE TO MARKETED DEVICE

The subject device is substantially equivalent in indications and design principles to the predicate devices shown above. Below are summary tables comparing the Indications for Use and the technological characteristics of the subject device and the predicate devices.

| Subject Device | Indications for Use Statement |
|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| External Hex Implants | Southern Implants' External Hex Implants are intended for surgical placement in the upper or lower<br>jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed<br>or immediate loading.<br>Southern Implants' External Hex Implants are intended for immediate function when good primary<br>stability with appropriate occlusal loading is achieved. |
| Primary Predicate Device | |
| K133049<br>3i T3 External Hex Dental<br>implants<br>Biomet 3i | 3i T3® Dental Implants are intended for surgical placement in the upper or lower jaw to provide a<br>means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans<br>with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary<br>abutment for fixed or removable bridgework, and to retain overdentures.<br>3i T3® Dental Implants are intended for immediate function on single tooth and/or multiple tooth<br>applications when good primary stability is achieved, with appropriate occlusal loading, in order to<br>restore chewing function. |
| Reference Predicate<br>Devices | |
| | K003620<br>Endosseous implant and<br>accessories (NSI Hexed<br>and Non-Hexed Implant<br>System)<br>NSI Inc |
| K020617<br>Endosseous implant and<br>accessories (NSI Hexed<br>and Non-Hexed Implant<br>System)<br>NSI Inc | Indication for Use: The NSI Implant System is intended to be implanted in the upper or<br>lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth,<br>partially edentulous prostheses, or full arch prostheses. |

| Comparison of Indications for Use Statements | | | | | |
|----------------------------------------------|--|--|--|--|--|
|----------------------------------------------|--|--|--|--|--|

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| K082651 | Indication for Use: The 24° Co-Axis implant is intended to be implanted in the upper or lower<br>jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially<br>edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement<br>and function on single and splinted multiple unit restorations when good primary stability is<br>achieved and with appropriate occlusal loading, to restore chewing function.<br>This implant is not intended, nor should it be used, in conjunction with an angled abutment. |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Endosseous implant and<br>accessories | |
| Southern Implants Inc. | |
| K053478 | Indication for Use: The NSI Implant System is intended to be implanted in the upper or lower jaw<br>arches to provide support for fixed or removable dental prostheses in a single tooth, partially<br>edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on<br>single and splinted multiple unit restorations when good primary stability is achieved and with<br>appropriate occlusal loading, to restore chewing function. |
| Endosseous implant and<br>accessories | |
| Northern Implants, LLC | |
| K070841 | Indication for Use: The NSI Implant System is intended to be implanted in the upper or lower jaw<br>arches to provide support for fixed or removable dental prostheses in a single tooth, partially<br>dentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on<br>single and splinted multiple unit restorations when good primary stability is achieved and with<br>appropriate occlusal loading, to restore chewing function. |
| Endosseous implant and<br>accessories | |
| Southern Implants Inc. | |
| K070905 | Indication for Use: The NSI Implant System is intended to be implanted in the upper or lower<br>jaw arches-to provide support for fixed or removable dental prostheses in a single tooth, partially<br>edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on<br>single and splinted multiple unit restorations when good primary stability is achieved and with<br>appropriate occlusal loading, to restore chewing function. |
| Endosseous implant and<br>accessories | |
| Southern Implants Inc. | |
| K092341 | BIOMET 3i Low Profile Abutments are intended for use as accessories to endosseous dental<br>implants to support a prosthetic device in a partially or completely edentulous patient. A dental<br>abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or<br>maxilla. The prosthesis is screw retained to the abutment. |
| Low Profile Abutment | |
| Southern Implants Inc. | |
| K160244 | VARIOflex |
| VARIOunite | Thommen Medical VARIOflex abutments are intended to be used in conjunction with Thommen<br>System dental implants in the maxillary and/or mandibular arch to provide support for crowns,<br>bridges and overdentures. |
| Thommen Medical AG | |
| | VARIOtemp |
| | Thommen Medical VARIOtemp abutments are intended to be used in conjunction with Thommen<br>System dental implants in the maxillary and/or mandibular arch to provide support for crowns,<br>bridges and overdentures. |
| K150669 | Neoss TiBase: |
| Neoss TiBase and CoCr<br>Abutments | Neoss Abutments are designed to be connected to the Neoss Implants and intended for use as an aid<br>in prosthetic rehabilitation.<br>The Neoss TiBase is compatible with the Sirona Dental System inCoris ZI Meso L. All digitally<br>designed copings and/or crowns for use with the Neoss TiBase Abutments are to be designed and<br>milled using the Sirona Dental CAD/CAM System.<br>Neoss CoCr Abutments:<br>Neoss abutments are designed to be connected to the Neoss Implants and intended for use as an aid in<br>prosthetic rehabilitation. |
| Neoss, Ltd. | |
| K120414 | The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the<br>following situations and with the following clinical protocols:<br>* replacing single and multiple missing teeth in the mandible and maxilla,<br>* immediate placement in extraction sites and in situations with a partially or completely healed<br>alveolar ridge,<br>* especially indicated for use in soft bone applications where implants with other implant surface<br>treatments may be less effective,<br>* immediate loading in all indications, except in single tooth situations on implants shorter than<br>8 mm, or in soft bone (type IV) where implant stability may be difficult to obtain and immediate<br>loading may not be appropriate.<br>The intended use for OsseoSpeed™ Plus 3.0S is limited to replacement of maxillary lateral incisors<br>and mandibular incisors. |
| OsseoSpeed™ Plus | |
| Astra Tech AB<br>[Dentsply] | |

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The subject device and predicate devices are substantially equivalent in intended use, design and function. All predicates are implant systems placed in the maxilla or mandible for single or multi-unit restorations with possible immediate loading. Minor differences in the Indications for Use Statement between the subject device and the primary predicate device do not change the intended use of implant placement and function. Compared to the primary predicate, the subject device Indications for Use statement simplifies repeated references to different types of restorations, in varying language, to say crowns, bridges or overdentures.

Subject device implants have an external hex implant/abutment interface and threaded design substantially equivalent to K133049, K003620, K020617, K082651, K053478, K070905. They have the same implant surface as K003620, K020617, K082651, K053478, K070841, and K070905. CoAxis implants have the same or a substantially equivalent angle as K082651. Subject device abutments are substantially equivalent in design and material to K053478, K070905, K092341, K150669 and K120414. Further detail is outlined in the table of technological characteristics below.

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# Comparison of Technological Characteristics

| | Subject Device | Primary Predicate | Reference Predicates | | | | | | | | | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------|-----------------------------------|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | External Hex Implants | 3i T3<br>External Hex Dental<br>implants | Endosseous implant and<br>accessories (NSI Hexed<br>and Non-Hexed Implant<br>System) | Endosseous implant<br>and accessories (NSI<br>Hexed and Non-Hexed<br>Implant System) | Endosseous implant and<br>accessories | Endosseous Dental<br>Implant System | Endosseous Dental<br>Implant System | Endosseous Dental<br>Implant System | Low Profile Abutment | VARIOunite | Neoss TiBase and CoCr<br>Abutments | OsseoSpeed™ Plus<br>Astra Tech AB<br>[Dentsply] |
| Comparison | Southern Implants (Pty) Ltd. | Biomet 3i | NSI Inc | NSI Inc | Southern Implants, Inc. | Northern Implants,<br>LLC | Southern Implants, Inc. | Southern Implants, Inc | Biomet 3i | Thommen Medical AG | Neoss, Ltd. | |
| 510(k) Number | K163634 | K133049 | K003620 | K020617 | K082651 | K053478 | K070841 | K070905 | K092341 | K160244 | K150669 | K120414 |
| IMPLANTS<br>Implant Design | Straight, Threaded;<br>Angled (12°, 24°), Threaded | Straight, Threaded | Straight, Threaded | Straight, Threaded | Straight, Threaded;<br>Angled (24°), Threaded | Straight, Threaded | Straight, Threaded;<br>Angled (12°), Threaded | Straight, Threaded | NA | NA | NA | Straight, Threaded |
| Implant Lengths (mm) | 6, 7, 8.5, 10, 11.5, 13, 15, 16,<br>18, 20 | 6.5, 8.5, 10, 11.5, 13, 15,<br>18 | 7, 8.5, 10, 11.5, 13, 15,<br>16, 18, 20 | 7, 10, 11.5, 13, 15 | 10, 11.5, 13, 15, 18 | 8.5, 10, 11.5, 13, 15, 18 | 8.5, 10, 11.5, 13, 15, 18 | 10.5, 13.5, 16.5 | NA | NA | NA | 6, 8, 9, 11, 13, 15, 17 |
| Implant Body Diameters<br>(mm) | 3.25, 3.75, 4.0, 4.7, 5.0, 5.7,<br>6.0 | 3.25, 4.0, 5.0, 6.0 | 3.75, 4.0, 5.0 | 4.7, 5.7, 6.0 | 4.7, 5.7 | 3.25 | 4.0 | 3.5, 4.3, 5.0 | NA | NA | NA | 3.0, 3.6, 4.2, 4.8, 5.4 |
| Implant Angle | 0°, 12°, 24° | NA | NA | NA | 24° | NA | 12° | 0° | NA | NA | NA | NA |
| Implant Material | CPTi | CPTi | CPTi | CPTi | CPTi | CPTi | CPTi | CPTi | NA | NA | NA | CPTi |
| Implant Surface | Grit blasted<br>Machine collar versions<br>available | Osseotite, NanoTite | Grit blasted | Grit blasted | Grit blasted | Grit blasted | Grit blasted | Grit blasted | NA | NA | NA | OsseoSpeed |
| Implant/ Abutment<br>Interface | External hex | External hex | External hex | External hex | External hex | External hex | External hex | Tri-lobe | External hex, Internal | Internal | Internal | Internal |
| Implant Sterilization | Sterile - irradiation | Sterile - irradiation | Sterile - irradiation | Sterile - irradiation | Sterile - irradiation | Sterile - irradiation | Sterile - irradiation | Sterile - irradiation | NA | NA | NA | Sterile - irradiation |
| ABUTMENTS | | | | | | | | | | | | |
| Abutment Angle | 0°, 12°, 17°, 24°, 30° | 0°, 15°, 17°, 25° | 0° | 0° | NA | 0° | 0° | 0° | 0°, 17°, 30° | 0° | 20° | 0°, 15°, 20°, 30° |
| Abutment Design /<br>Sterilization | Sterile: Cover Screw , Healing<br>Caps, Healing Abutments,<br>Titanium Abutments, Anatomic<br>Abutments, Cosmetic Abutments,<br>Compact Conical Abutments<br>Non-sterile: Gold Abutments,<br>Chrome Cobalt Abutments,<br>Passive Abutments | Specific Abutments not<br>identified in 510(k) Summary | No 510(k) Summary<br>Available | Specific Abutments not<br>identified in 510(k)<br>Summary | NA | Specific Abutments not<br>identified in 510(k)<br>Summary | Specific Abutments not<br>identified in 510(k)<br>Summary | Specific Abutments not<br>identified in 510(k)<br>Summary | Non-Sterile Titanium<br>Abutments | Non-Sterile Titanium<br>Abutments | Non-Sterile TiBase<br>Abutments and CoCr<br>Abutments | Sterile and Non-Sterile<br>Abutments: Cover screw<br>Healing Abutments,<br>Temporary Abutments,<br>Cast-To Abutments, Ball<br>Abutments, Straight and<br>Angled Abutments |
| Abutment Diameters | 3.43, 3.5, 3.6, 4.05, 4.5, 4.6, 4.8,<br>5.0, 5.2, 5.5, 6.0, 6.2, 6.4, 6.5, 7.0,<br>7.5 | Specific Abutments not<br>identified in 510(k) Summary | No 510(k) Summary<br>Available | Specific Abutments not<br>identified in 510(k)<br>Summary | NA | Specific Abutments not<br>identified in 510(k)<br>Summary | Specific Abutments not<br>identified in 510(k)<br>Summary | Specific Abutments not<br>identified in 510(k)<br>Summary | 3.4, 4.1, 5.0 | 3.5, 4.0, 4.5, 5.0 6.0 | 4.1 | 3.0, 3.6, 4.2, 4.8, 5.4 |
| Surface Treatment | Smooth, Grooved | NA | NA | NA | NA | Smooth, Grooved | Smooth | NA | NA | NA | Smooth | NA |
| Restoration | Single-unit or multi-unit | Single-unit or multi-unit | Single-unit or multi-unit | Single-unit or multi-unit | NA | Single-unit or multi-unit | Multi-unit | Single-unit or multi-unit | Single-unit or multi-unit | Single-unit or multi-unit | Single-unit or multi-unit | Single-unit or multi-unit |
| Abutment Material | CPTi, Titanium alloy, Gold,<br>CoCr | Titanium alloy | Gold alloy | Titanium alloy,<br>Gold alloy | NA | CPTi,<br>Titanium alloy, Gold<br>alloy | CPTi or<br>Titanium alloy | Titanium alloy, Gold<br>alloy, Stainless Steel | Titanium alloy | Titanium alloy | Titanium alloy, CoCr | Titanium alloy, Gold<br>Zirconia, PEEK |

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#### CONCLUSION

The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject devices encompass the same range of physical dimensions, including diameter, length and angle of the abutments. The subject and predicate devices are packaged in similar materials and are to be sterilized using similar methods.

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.