Single Platform SP1 Implant System

K232418 · Southern Implants (Pty), Ltd. · DZE · Dec 1, 2023 · Dental

Device Facts

• Record ID: K232418
• Device Name: Single Platform SP1 Implant System
• Applicant: Southern Implants (Pty), Ltd.
• Product Code: DZE · Dental
• Decision Date: Dec 1, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Single Platform SP1 Implant System is 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. The Single Platform SP1 Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved. The Single Platform SP1 implants in lengths 20, 22 and 24 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. The Conventional Abutments and Prosthetic Screws are premanufactured prosthetic components directly connected to endosseous dental implants and intended for use in fully edentulous or partially edentulous maxilla and/or mandible to provide support for crowns, bridges or overdentures. The TIB and Passive Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB and Passive abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The Southern Implants Temporary Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

Device Story

Fully threaded root-form dental implants with internal cone/hex interface; provided in diameters 3.5, 4.0, 5.0 mm. System includes cover screws, healing abutments, temporary titanium cylinders, equator overdenture abutments, compact conical abutments, and TIB/passive abutments for digital workflows. Used in dental clinics by clinicians for prosthetic rehabilitation. Digital workflow utilizes desktop scanners, 3Shape Abutment Designer software, and CAM milling of zirconia mesostructures. TIB/passive abutments serve as interface between implant and custom zirconia restoration. Provides support for crowns, bridges, or overdentures; restores chewing function. Implants manufactured from ASTM F67 unalloyed titanium; abutments from ASTM F136 titanium alloy. Fatigue performance validated via ISO 14801 testing.

Clinical Evidence

No clinical data included. Substantial equivalence supported by non-clinical bench testing: engineering/dimensional analysis, sterilization validation (ISO 11137-1, ISO 17665), bacterial endotoxin testing, and static/dynamic compression-bending fatigue testing (ISO 14801). MR safety evaluated via comparison to predicate devices.

Technological Characteristics

Root-form dental implants; internal cone and hex interface. Materials: Unalloyed titanium (ASTM F67) for implants/cover screws; titanium alloy (ASTM F136) for abutments/screws. Surface: Grit-blasted endosseous surface with 3mm machined coronal collar. Sterilization: Gamma irradiation. Connectivity: Digital workflow integration via 3Shape Abutment Designer software (locked library).

Indications for Use

Indicated for surgical placement in upper or lower jaw for prosthetic attachment of crowns, bridges, or overdentures in edentulous or partially edentulous patients. Implants 20-24mm in maxilla restricted to splinted multiple-unit restorations. Temporary abutments indicated for provisional use up to 180 days.

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

• Neodent Implant System – GM Line (K163194)

Reference Devices

• Neodent Implant System - GM Helix LG (K190958)
• Deep Conical (DC) Implants and Accessories (K163060)
• Provata Implant System (K222457)
• Neodent Implant System GM Line (K180536)
• Neodent Implant System Temporary Abutments (K191191)
• Blue Sky Bio Multi One Implant System (K212785)
• NexxZR T (K130991)
• Multilink Hybrid Abutment Cement (K130436)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Southern Implants (Pty) Ltd Michelle dos Santos Senior Design Engineer 1 Albert Road Irene, Gauteng 0062 SOUTH AFRICA

Re: K232418

Trade/Device Name: Single Platform SP1 Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE. NHA. PNP Dated: November 1, 2023 Received: November 2, 2023

Dear Michelle dos Santos:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K232418

Device Name Single Platform SP1 Implant System

Indications for Use (Describe)

For the implants:

The Single Platform SP1 Implant System is 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. The Single Platform SP1 Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

The Single Platform SP1 implants in lengths 20, 22 and 24 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

For the conventional abutment and screws:

The Conventional Abutments and Prosthetic Screws are premanufactured prosthetic components directly connected to endosseous dental implants and intended for use in fully edentulous maxilla and/or maxilla and/or mandible to provide support for crowns, bridges or overdentures.

For the Titanium Abutment Bases and Passive Abutments:

The TIB and Passive Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB and Passive abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

For the Temporary Titanium Cylinders:

The Southern Implants Temporary Titanium Abutments are prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

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

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

| Form Approved: | OMB No. 0910-0120 |
|------------------|-------------------|
| Expiration Date: | 06/30/2023 |

See PRA Statement below.

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# 510(k) Summary - K232418

# Single Platform SP1 Implant System

# Southern Implants (Pty) Ltd

# December 01, 2023

#### ADMINISTRATIVE INFORMATION

| Manufacturer Name | Southern Implants (Pty) Ltd<br>1 Albert Road<br>Irene, Gauteng, 0062 South Africa<br>Telephone: [phone]<br>Fax: [phone] |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Colin Saffy<br>Head of Regulatory Affairs and Quality<br>Email: [e-mail] |

# DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name | Single Platform SP1 Implant System |
|---------------------------|------------------------------------|
| Common Name | Dental implant |
| Classification Name | Endosseous dental implant |
| Classification Regulation | 21 CFR 872.3640, Class II |
| Product Code | DZE, NHA, PNP |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |

#### PREDICATE DEVICE INFORMATION

#### Primary predicate devices:

K163194, Neodent Implant System – GM Line, JJGC Industria e Comercio de Materiais Dentarios SA.

#### Reference devices:

K190958, Neodent Implant System - GM Helix LG, JJGC Industria e Comercio de Materiais Dentarios SA. K163060, Deep Conical (DC) Implants and Accessories, Southern Implants (Pty) Ltd.

- K222457, Provata Implant System, Southern Implants (Pty) Ltd.
- K180536, Neodent Implant System GM Line, JJGC Industria e Comercio de Materiais Dentarios SA.
- K191191. Neodent Implant System Temporary Abutments, JJGC Industria e Comercio de Materiais Dentarios SA.
- K212785, Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments, Blue Sky Bio, LLC.
- K130991, NexxZRTM T and NexxZRTM T, Sagemax Bioceramics, Inc.
- K130436, Multilink Hybrid Abutment Cement, Ivoclar Vivadent, Inc.

#### INDICATIONS FOR USE STATEMENT

#### For the implants:

The Single Platform SP1 Implant System is 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. The

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Single Platform SP1 Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

The Single Platform SP1 implants in lengths 20, 22 and 24 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

#### For the conventional abutment and screws:

The Conventional Abutments and Prosthetic Screws are premanufactured prosthetic components directly connected to endosseous dental imended for use in fully edentulous or partially edentulous maxilla and/or mandible to provide support for crowns, bridges or overdentures.

#### For the Titanium Abutment Bases (TIB) and Passive Abutments:

The TIB and Passive Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB and Passive abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

#### For the Temporary Titanium Cylinders:

The Southern Implants Temporary Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

#### SUBJECT DEVICE DESCRIPTION

This submission includes fully threaded root-form dental implants with an internal cone and hexagon interface and mating abutments. The implants are provided in three diameters: Ø3.5, Ø4.0 and Ø5.0 mm. The implants are provided in a straight (0° angled) configuration only, with a 3.0 mm extended machined coronal section. The implants are provided in one prosthetic diameter (2.95 mm implants are provided in overall leneths of 8, 10, 11.5, 13, 16, 18 and 20 mm. The Ø4.0 mm implants are provided in overall lengths of 8, 10, 11.5, 13, 16, 18, 20, 22 and 24 mm. The Ø5.0 mm implants are provided in overall lengths of 8, 10, 11.5, 13, 16, and 18 mm.

This submission also includes: a Cover Screw, Healing Abutments in four diameters and multiple gingival heights, Titanium Cylinder Abutments for temporary restorations, Passive Abutments with a plastic burn-out component, Equator Overdenture Abutments in multiple gingival heights, Compact Conical Abutments in straight (0) and angled (17° and 30°) designs, TIB Abutment Bases, and abutment screws.

The Passive Abutments may be restored using either traditional cast-on workflows or digital CAD/CAM workflows using milled zirconia restorations (similar use to the TIB Abutment Bases).

Using the traditional cast-on workflow, the Passive Abutments function as UCLA castable abutments which interface with a plastic, burn-out sleeve used to fabricate a prosthesis that is bonded directly to the top of the abutment, limited to a straight (0°) restoration when utilizing precious metal cast-on restorations.

Using digital CAD/CAM workflows, the TIB Abutment Bases and Passive Abutments function as two-piece abutment designs, consisting of standard premanufactured titanium alloy abutments for supporting the second half (or top-half) of the abutment, a hybrid/crown dental restoration and mesostructure (SageMaxx Zirconia) bonded with cement (Ivoclar Vivadent Multilink Hybrid cement). The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The TIB Abutment Bases and Passive Abutments then serves as the interface between the endosseous implant and the Zirconia restoration. The TIB Abutment Bases and Passive Abutments are designed to support the restoration on an endosseous implant in order to restore chewing function for the patient.

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The mesostructured restoration is a CAD/CAM designed prosthesis milled out of Zirconia (SageMaxx Zirconia), which is designed to fit the abutment base in order to restore chewing function for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case-by-case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration and a maximum allowable angulation of 20° for the mesostructured component.

All Single Platform SP1 implants are manufactured from unalloyed titanium conforming to ASTM F67, with a smooth machined collar (extended machined surface of 3 mm). The remainder of the entire endosseous threaded surface) is grit-blasted. The subject device implant material and surface is identical to the implants cleared in K222457 and K163060. The Cover Screw and Healing Abutments are manufactured from unalloyed titanium conforming to ASTM F67. The remaining Abutments are manufactured from titanium alloy conforming to ASTM F136. The abutment screws are manufactured from titanium alloy conforming to ASTM F136. All subject device components are manufactured in the same facilities using the same materials and manufacturing processes as used for the Southern Implants devices previously cleared in K222457 and K163060.

# PERFORMANCE DATA

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence.

Non-clinical data submitted to demonstrate substantial equivalence includes: engineering analysis; dimensional analysis; sterilization validation according to ISO 11137-1, ISO 17665-1, ISO 17665-1, ISO 17665-2; bacterial endotoxin according to USP 39-NF 34; static and dynamic compression-bending according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants; scanning and milling validation for the Passive Abutments; and MR safety testing as per the recommendations of the FDA Guidance Document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment".

Non-clinical data referenced, or relied upon to demonstrate substantial equivalence includes: biocompatibility evaluations according to ISO 10993-1 (referenced from K222457 and K163060); sterile barrier shelf life (referenced from K222457); validated steam sterilization instructions per ISO 17665-2 (applicable to the Passive Abutments and Titanium Abutment Bases (TIB) which are provided non-sterile and intended for end-user sterilization - referenced from K193084); software validation testing as per the FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices (referenced from K193084); and scanning and milling validation for the Titanium Abutment Bases (TIB) (referenced from K193084).

No clinical data were included in this submission.

Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the 3Shape Abutment Designer Software (only applicable to the TIB Abutment Bases and Passive Abutments when using the digital CAD/CAM workflows for milled zirconia restoration design). Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the top half component of the two-piece abutment outside of the allowable design limitations, including screenshots under user verification testing. In addition, the encrypted abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified within the abutment design library.

MR safety testing as per the recommendations of the FDA Guidance Document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment'' (ASTM F2503, ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119) was performed on the previously cleared devices, K222457, PROVATA Implant System. The subject devices were compared to the predicate devices. The subject devices are not worst-case Southern Implants components in terms of material, size or shape and therefore the subject devices can be considered equally MR Safe as the predicate devices.

# EQUIVALENCE TO MARKETED DEVICE

Southern Implants (Pty) Ltd submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices listed above.

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For the subject device Single Platform SP1 implants, the primary predicate device is K163194, and the reference devices are K190958, K163060, K222457 and K212785.

For the subject device Conventional Abutments and Prosthetic Screws for Single Platform SP1 implants, the reference devices are K163194, K163060 and K222457.

For the subject device TIB Abutment Bases and Passive Abutments for Single Platform SP1 implants, the reference devices are K222457, K180536 and K163060.

For the subject device Temporary Titanium Abutments for Single Platform SP1 implants, the reference devices are K222457 and K191191.

A comparison of the technological characteristics of the subject devices and the predicate devices is provided in the following tables.

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| | Subject Device | Primary<br>Predicate<br>Device | Reference<br>Device | Reference<br>Device | Reference<br>Device | Reference<br>Device |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison | Single Platform<br>SP1 Implant<br>System<br>Southern<br>Implants (Pty)<br>Ltd | K163194<br>Neodent<br>Implant System<br>- GM Line<br>JJGC Industria<br>e Comercio de<br>Materiais<br>Dentarios SA | K190958<br>Neodent<br>Implant System<br>- GM Helix LG<br>JJGC Industria<br>e Comercio de<br>Materiais<br>Dentarios SA | K163060<br>Deep Conical<br>(DC) Implants<br>and Accessories<br>Southern<br>Implants (Pty)<br>Ltd | K222457<br>Provata<br>Implant System<br>Southern<br>Implants (Pty)<br>Ltd | K212785<br>Blue Sky Bio<br>Dental Implant<br>System -<br>BIO MAX<br>MULTI ONE<br>Blue Sky Bio,<br>LLC |
| Implant | | | | | | |
| Indications<br>for Use<br>Statement | The<br>Single<br>Platform<br>SP1<br>Implant System is<br>intended<br>for<br>surgical placement<br>in the upper or<br>lower jaw to<br>provide a means for<br>prosthetic<br>attachment<br>of<br>crowns, bridges or<br>overdentures<br>utilizing delayed or<br>immediate loading.<br>The<br>Single<br>Platform<br>SP1<br>Implant System is<br>intended<br>for<br>immediate function<br>when good primary<br>stability<br>with<br>appropriate<br>occlusal loading is<br>achieved.<br>The<br>Single<br>Platform<br>SP1<br>implants in lengths<br>20, 22 and 24 mm<br>when placed in the<br>maxilla are only<br>indicated<br>for<br>multiple<br>unit<br>restorations<br>in<br>splinted<br>applications<br>that<br>utilize at least two<br>implants. | The<br>Neodent<br>Implant System is<br>intended to be<br>surgically placed in<br>the bone of the<br>upper or lower jaw<br>to provide support<br>for prosthetic<br>devices such as<br>artificial teeth, to<br>restore chewing<br>function. It may be<br>used with single-<br>stage or two-stage<br>procedures, for<br>single or multiple<br>unit restorations,<br>and may be loaded<br>immediately when<br>good primary<br>stability is achieved<br>and with<br>appropriate<br>occlusal loading. | The<br>Neodent<br>Implant System is<br>intended to be<br>surgically placed in<br>the bone of the<br>upper or lower jaw<br>to provide support<br>for prosthetic<br>devices, such as<br>artificial teeth, to<br>restore chewing<br>function. It may be<br>used with single-<br>stage or two-stage<br>procedures, for<br>single or multiple<br>unit restorations,<br>and may be loaded<br>immediately when<br>good primary<br>stability is achieved<br>and with<br>appropriate<br>occlusal<br>loading.<br>The Neodent GM<br>Helix LG implants<br>can be placed<br>bicortically in cases<br>of reduced bone<br>density.<br>The<br>Neodent GM Helix<br>LG implants are<br>only indicated for<br>multiple unit<br>restorations in<br>splinted<br>applications that<br>utilize at least two<br>implants. | Southern Implants<br>Dental Implants are<br>intended for both<br>one- and two-stage<br>surgical procedures<br>in the following<br>situations and with<br>the following<br>clinical protocols:<br>- replacing<br>single and<br>multiple<br>missing teeth<br>in the mandible<br>and maxilla,<br>- immediate<br>placement in<br>extraction sites<br>and in<br>situations with<br>a partially or<br>completely<br>healed alveolar<br>ridge,<br>- immediate<br>loading in all<br>indications,<br>except in<br>single tooth<br>situations on<br>implants<br>shorter than<br>8mm or in soft<br>bone (type IV)<br>where implant<br>stability may<br>be difficult to<br>obtain and<br>immediate<br>loading may<br>not be<br>appropriate.<br>The intended use<br>for 3.0 Deep<br>Conical implants is<br>limited to<br>replacement of<br>maxillary lateral<br>incisors and<br>mandibular<br>incisors. | The<br>Provata<br>Implant System is<br>intended for<br>surgical placement<br>in the upper or<br>lower jaw to<br>provide a means for<br>prosthetic<br>attachment of<br>crowns, bridges or<br>overdentures<br>utilizing delayed or<br>immediate loading.<br>The<br>Provata<br>Implant System is<br>intended for<br>immediate function<br>when good primary<br>stability with<br>appropriate<br>occlusal loading is<br>achieved.<br>The intended use<br>for the 03.30<br>Provata implants is<br>limited to<br>replacement of<br>maxillary and<br>mandibular lateral<br>and central incisors.<br>The 12° angled Co-<br>Axis Provata<br>Implants are<br>intended to only be<br>used with straight<br>abutments. | Blue Sky Bio Multi<br>One Implant System<br>is intended for<br>surgical placement<br>in the bone of the<br>upper or lower jaw<br>to provide support<br>for prosthetic<br>devices to restore<br>chewing function.<br>Implants may be<br>used with single-<br>stage or two-stage<br>procedures.<br>They can be<br>loaded immediately when<br>good primary<br>stability is achieved<br>and with<br>appropriate occlusal<br>loading. Blue Sky<br>Bio Multi One<br>Implants are<br>indicated for multi-<br>unit restorations in<br>splinted<br>applications.<br>Blue<br>Sky Bio Multi One<br>Implant System<br>with a 45°<br>angulation are<br>indicated for<br>surgical installation<br>in the pterygoid<br>region only, in cases<br>of severe jaw<br>resorption, in order<br>to restore patient<br>esthetics and<br>chewing function. |
| Product<br>Code | DZE | DZE | DZE | DZE | DZE | DZE |
| Intended<br>Use | Functional<br>and esthetic<br>rehabilitation of<br>the edentulous<br>maxilla. | Root-form<br>implants<br>intended to<br>replace natural<br>tooth root. | Root-form<br>implants<br>intended to<br>replace natural<br>tooth root. | Bone anchored<br>dental prosthetic | Functional<br>and esthetic<br>rehabilitation of<br>the edentulous<br>maxilla. | Root-form<br>implants intended<br>to replace natural<br>tooth root. |
| Reason for<br>Predicate/<br>Reference | Not applicable | General implant<br>design, length<br>and diameter<br>Internal cone<br>and hex<br>connection | Implant lengths | General design<br>and diameter<br>Implant material<br>and surface<br>Sterility<br>Sterilization<br>Usage | Machined collar<br>Implant material<br>and surface<br>Shelf-life of<br>packaging<br>Sterility<br>Sterilization<br>Usage | Implant diameter<br>and length<br>combination |

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| Item Code | MSC-SP35;<br>MSC-SP40;<br>MSC-SP50 | GM Helix | GM Helix LG | DCC35;<br>DCC40;<br>DCC50; DCT35;<br>DCT40; DCT50 | MSC-PRO300 | BIOMAX<br>MULTI ONE<br>Ø 3.25 mm<br>Straight |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------|
| Implant<br>Design | Fully threaded<br>tapered root-<br>form dental<br>implants | Threaded root-<br>form implant<br>with internal<br>GM Morse taper<br>connection with<br>internal hex | Threaded root-<br>form implant<br>with internal<br>GM Morse taper<br>connection with<br>internal hex | Fully threaded<br>cylindrical and<br>tapered root-<br>form dental<br>implants | Fully threaded<br>tapered root-<br>form dental<br>implants | One-piece<br>implant/abutment |
| Implant<br>Diameter | 3.50, 4.0 and 5.0<br>mm | 3.50, 3.75, 4.0,<br>4.3 and 5.0 mm | 3.75 and 4.0 mm | 3.52, 4.0 and<br>5.0mm | 3.30 mm | 3.25 mm |
| Implant<br>Length | For Ø3.5<br>implants: 8, 10,<br>11.5, 13, 16, 18,<br>20 mm<br>For Ø4.0<br>implants: 8, 10,<br>11.5, 13, 16, 18,<br>20, 22, 24 mm<br>For Ø5.0<br>implants: 8, 10,<br>11.5, 13, 16, 18<br>mm | 8, 10, 11.5, 13,<br>16, 18 mm | 20, 22, 25 mm | 8, 9, 11, 13, 15<br>mm | 8.5, 10, 11.5, 13,<br>15, 18 mm | 10, 11.5, 13, 16,<br>18, 20 mm |
| Platform<br>Angle,<br>Relative to<br>orthogonal<br>to implant<br>long axis | 0° (straight) | 0° (straight) | 0° (straight) | 0° (straight) | 0° (straight) | 0° (straight) |
| Implant<br>Platform<br>Diameter | For Ø3.5<br>implants: 3.30<br>mm<br>For Ø4.0<br>implants: 3.80<br>mm<br>For Ø5.0<br>implants: 4.50<br>mm | Not provided | Not provided | For Ø3.52 and<br>Ø4.0 implants:<br>3.10 mm<br>For Ø5.0<br>implants: 4.10<br>mm | 3.10 mm | 3.50 mm |
| Implant<br>Prosthetic<br>Diameter | 2.95 mm | Not provided | Not provided | For Ø3.52 and<br>Ø4.0 implants:<br>2.80 mm<br>For Ø5.0<br>implants: 3.83<br>mm | 2.90 mm | 3.50 mm |
| Implant<br>Interface | Internal Cone<br>and Hex | GM interface,<br>16° Morse taper<br>with anti-<br>rotational<br>features (Internal<br>cone and hex) | GM interface,<br>16° Morse taper<br>with anti-<br>rotational<br>features (Internal<br>cone and hex) | Deep Conical<br>(internal cone<br>and double hex) | Internal Hex | One piece |
| Implant<br>Material | Unalloyed<br>titanium (ASTM<br>F67) Grade 4,<br>and UTS ≥<br>900MPa (cold-<br>worked) | Unalloyed<br>titanium (ASTM<br>F67) Grade 4 | Unalloyed<br>titanium (ASTM<br>F67) Grade 4 | Unalloyed<br>titanium (ASTM<br>F67) Grade 4,<br>and UTS ≥<br>900MPa (cold-<br>worked) | Unalloyed<br>titanium (ASTM<br>F67) Grade 4,<br>and UTS ≥<br>900MPa (cold-<br>worked) | Ti-6Al-4V<br>Titanium Grade<br>5 alloy (ASTM<br>F136) |
| Implant<br>Endosseous<br>Surface | Grit-blasted with<br>a 3.0mm<br>machined<br>section only at<br>coronal end | Grit-blasted and<br>acid etched<br>(NeoPoros and<br>Acqua) | Grit-blasted and<br>acid etched<br>(NeoPoros) | Grit-blasted with<br>a 0.3mm<br>machined<br>section only at<br>coronal end | Grit-blasted with<br>a 3.0mm<br>machined<br>section only at<br>coronal end | Grit blasted and<br>acid etched |
| How Provided | | | | | | |
| Sterility | Provided sterile | Provided sterile | Provided sterile | Provided sterile | Provided sterile | Provided sterile |
| Sterilization | Gamma<br>irradiation | Gamma<br>irradiation | Gamma<br>irradiation | Gamma<br>irradiation | Gamma<br>irradiation | Gamma<br>irradiation |
| Usage | Single-patient,<br>single-use | Single-patient,<br>single-use | Not provided | Single-patient,<br>single-use | Single-patient,<br>single-use | Single-patient,<br>single-use |
| Shelf life of<br>packaging | 10 years | Not provided | Not provided | 5 years | 10 years | Not provided |

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| Comparison | Subject Device | Primary Predicate Device<br>K163194 | Reference Device<br>K163060 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Conventional Abutments and | Neodent Implant System - GM | Deep Conical (DC) Implants and |
| | Prosthetic Screws for Single<br>Platform SP1 Implant System | Line<br>JJGC Industria e Comercio de | Accessories |
| | Southern Implants (Pty) Ltd | Materiais Dentarios SA | Southern Implants (Pty) Ltd |
| Indications for Use<br>Statement | The Conventional Abutments and<br>Prosthetic Screws are<br>premanufactured prosthetic<br>components directly connected to<br>endosseous dental implants and<br>intended for use in fully<br>edentulous or partially edentulous<br>maxilla and/or mandible to<br>provide support for crowns,<br>bridges or overdentures. | The Neodent Implant System is<br>intended to be surgically placed in<br>the bone of the upper or lower jaw<br>to provide support for prosthetic<br>devices such as artificial teeth, to<br>restore chewing function. It may be<br>used with single-stage or two-stage<br>procedures, for single or multiple<br>unit restorations, and may be<br>loaded immediately when good<br>primary stability is achieved and<br>with appropriate occlusal loading. | Southern Implants Dental Implants<br>are intended for both one- and two-<br>stage surgical procedures in the<br>following situations and with the<br>following clinical protocols:<br>- replacing single and multiple<br>missing teeth in the mandible<br>and maxilla,<br>- immediate placement in<br>extraction sites and in situations<br>with a partially or completely<br>healed alveolar ridge,<br>- immediate loading in all<br>indications, except in single<br>tooth situations on implants<br>shorter than 8mm or in soft bone<br>(type IV) where implant stability<br>may be difficult to obtain and<br>immediate loading may not be<br>appropriate.<br>The intended use for 3.0 Deep<br>Conical implants is limited to<br>replacement of maxillary lateral |
| | | | incisors and mandibular incisors. |
| Product Code | NHA | NHA | NHA…