Predicate Devices

K163634, External Hex Implants, Southern Implants (Pty) Ltd.

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a dental implant system and its components, focusing on materials, dimensions, intended use, and performance testing. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.

Therapeutic

Yes
The dental implants described are therapeutic because they are intended for "surgical placement... to provide a means for prosthetic attachment of crowns, bridges or overdentures," which directly addresses and treats the loss of teeth, aiming to restore esthetics and chewing function.

Diagnostic

No

The device is an implantable dental device (dental implants) intended for prosthetic attachment, not for diagnosing a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly details physical dental implants made of titanium, including their dimensions, surface treatments, and mechanical properties. There is no mention of software as the primary or sole component of the device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Definition of IVD: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
Intended Use: The intended use of this device is for "surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures." This is a surgical implant used directly in the body for structural support and prosthetic attachment.
Device Description: The device is described as "fully-threaded, tapered, root-form dental implants." This further confirms its nature as a physical implant for surgical placement.
Lack of IVD Characteristics: There is no mention of analyzing biological specimens, providing diagnostic information, or any of the typical functions of an IVD.

Therefore, this device is a dental implant, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For Standard Length IBR36d Implant Range:

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. When using Southern Implants' Standard Length IBR36D Implants with angulation of 36° a minimum of 4 implants must be used and splinted
The angled Co-Axis External Hex Implants are intended to be used with straight multiple-unit abutments (Compact Conical abutments) only with no additional angulation allowable on the restoration.

For Extra Length IBR36d Implant Range:

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.

Extra Length IBR36d Implants can be placed bicortically in cases of reduced bone density. Extra Length IBR36d Implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. Extra Length IBR36d Implants are indicated for surgical installation in the pterygoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.

The angled Co-Axis External Hex Implants are intended to be used with straight multiple-unit abutments (Compact Conical abutments) only with no additional angulation allowable on the restoration.

For Extra Length IBR24d Implant Range:

Southern Implants' External Hex Implants are intended for surgical placement in the upper 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.

Southern Implants' Extra Length IBR24d Implant Range when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

The angled Co-Axis External Hex Implants are intended to be used with straight multiple-unit abutments (Compact Conical abutments) only with no additional angulation allowable on the restoration.

Product codes (comma separated list FDA assigned to the subject device)

DZE

Device Description

External Hex implants are fully-threaded, tapered, root-form dental implants with an external hexagonal abutment interface, and are threaded internally for attachment of mating multiple-unit abutments, cover screws, or healing abutments. The External Hex implants have a Co-Axis design with the prosthetic platform angled at 36° and 24° (inclined) from orthogonal to the long axis of the implant.

Additionally, the External Hex implants are provided in two configurations, regular surface and MSC surface implants. The regular surface implants are fully roughened excluding a machined collar at the coronal aspect of the implant. The MSC surface implants have an extended length of machined area at the coronal aspect of the implant, with the remaining implant length being roughened.

The implants subject to this submission are the External Hex IBR36d and IBR24d implant range. The reduced platform MSC-IBR24d implants are only provided as Co-Axis implants, in both the regular surface and MSC surface configuration. The reduced platform IBR36d implants are only provided as Co-Axis implants, in regular surface configuration. The IBR36d implants are available in two body configurations depending on the implant length.

The IBR36d implants of overall lengths 8.5 mm to 18 mm have a major body diameter of 4.20 mm tapering to 2.60 mm. The IBR36d implants of overall lengths 20 mm to 24 mm have a major body diameter of 4.20 mm tapering to 2.00 mm. Both the IBR24d and MSC-IBR24d implants of overall lengths 20 mm have a major body diameter 4.07 mm tapering to 2.60 mm. All of the subject device implants utilize the same prosthetic connection, previously cleared in K163634.

All External Hex implants are manufactured from unalloyed titanium (cold-worked, grade 4, UTS >= 900 MPa). The MSC-IBR24d implants have a smooth machined surface of length 3 mm extending parallel from the implant prosthetic platform for all implant lengths. The remainder of the implant is grit-blasted with aluminum oxide particles to provide a surface roughness of 1-2 um. The subject device implant material and surface are identical to those of the implants cleared in K163634.

The IBR36d and IBR24d External Hex implants are provided with a dedicated pre-mounted fixture mount of 36° and 24 respectively, similar to that provided with the other Co-Axis External Hex implants cleared in K163634.

All of the subject device implants utilize the same prosthetic connection, previously cleared in K163634 for the External Hex IBR24d and MSC-IBR24d implants. The External Hex implants are used in conjunction with the same abutments cleared for use with the External Hex IBR24d implants (implants cleared in K163634). These abutments are cleared in K053478, K070841, K093562, and K163634. The components that are compatible with the External Hex implants include Cover Screw, Healing Abutment, and Compact Conical Abutments. The Compact Conical Abutments are compatible with Temporary Titanium Abutment Cylinders, Gold Abutment Cylinders, and Passive Abutments.

The subject device Co-Axis implants are indicated for use with straight multiple-unit abutments with a 0° allowable restoration angle, only. This includes restricting straight abutments, that can be restored on a multi-unit abutment, that have an allowable restoration angle of up to 20° associated with them, so that they may only have a restoration angle of 0°. Thus, all the possible compatible abutments will have a 0° allowable restoration angle.

All External Hex implants are provided sterile to the end-user in a single-unit package, and are for single-patient, single-use only.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper or lower jaw

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone perforamnce, key results)

Non-clinical data:

Study Type: Biocompatibility evaluations
Sample Size: Not specified
Key Results: According to ISO 10993-1 (referenced from K163634), the device is biocompatible.
Study Type: Engineering analysis
Sample Size: Not specified
Key Results: Not specified
Study Type: Dimensional analysis
Sample Size: Not specified
Key Results: Not specified
Study Type: Sterilization according to ISO 11137-1, ISO 11137-2
Sample Size: Not specified
Key Results: Not specified
Study Type: Bacterial endotoxin according to USP 39-NF 34
Sample Size: Not specified
Key Results: Not specified
Study Type: Sterile barrier shelf life
Sample Size: Not specified
Key Results: Referenced from K222457
Study Type: Static and dynamic compression-bending to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. Fatigue testing was performed on the representative worst-case construct for angulation and abutment/screw materials.
Sample Size: Twelve (12) samples for each subject device group.
Key Results: The fatigue limit was determined to be where a total of three (3) samples endured 5 x 10^6 cycles with no failures. Results of mechanical testing confirmed that the strength of the subject device is sufficient for its intended use.
Study Type: 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 F2013, ASTM F2182, ASTM F2119).
Sample Size: Not specified
Key Results: The subject devices were compared to the predicate devices and 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.

Clinical data:

Study Type: Retrospective analysis of real-world clinical data (Standard length IBR36d) utilizing clinical literature.
Sample Size: Not specified, data from 14 articles reviewed.
Key Results: Data demonstrates implants with length of 7-18mm placed within angulation range of 20-50° as part of splinted approach present with similar success rates to standard implants. Survival rates and clinical indices were favorable in both maxillary and mandibular applications. Immediate and delayed loading protocols showed favorable results. The standard length IBR36d implants (8-18mm length, 36° angle) are within the window of successful implants identified in the literature.
Study Type: Retrospective analysis of real-world clinical data (Extra length IBR36d) utilizing clinical literature.
Sample Size: Not specified, data from 5 articles reviewed.
Key Results: Long implants (10-25 mm in length, angles 15-90°) used in the pterygoid region have similar success rates to standard implants. The extra length IBR36d implants (20-24mm length, 36° angle) are within the window of successful implants identified in the literature.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Survival rates for Standard length IBR36d implants:

97.51% at up to 17 years in maxilla, 96.91% at up to 16 years in mandible ([1] E. L. Agliardi et al.)
100% survival rate at 3 years (42 m) ([2] M. Ayna et al.)
98.7% survival rate at 36 months ([3] C. A. Babbush et al.)
96.1% for tilted and 95.7% for axial implants after 5 years ([4] M. Hopp et al.)
10% implant failures, but equal for tilted and straight implants ([5] R. A. Landázuri-Del Barrio et al.)
96.6% after 5 years ([6] A. Lopes et al.)
94.5% after 7 years ([7] A. Lopes et al.)
94.8% at 10 years for both axial and tilted implants ([8] P. Malo et al.)
98.1% for tilted implants at 3 years ([9] P. Maló et al.)
93.9% cumulative survival rate after 13 years ([10] P. Maló et al.)
93% after 18 years ([11] P. Maló et al.)
100% survival rate for tilted implants at 13 months ([12] H. Najafi et al.)
No statistically significant difference in survival rates between axial and tilted implants at 3 years (42 m) ([13] G. Sannino and A. Barlattani)
100% survival rate ([14] Á. L. Szabó et al.)

Survival rates for Extra length IBR36d implants:

90% to 100% after 1 to 12 years with minimal complications, for pterygoid implants ([1] P. V. R. Nag et al.)
Weighted average success of pterygoid implants was 90.7% ([2] E. Candel et al.)
96.8% at 2 years for TTPHIL pterygoid implant surgery protocol ([3] V. P. R. Nag et al.)
Mean implant survival rate of 94.87% ([4] R. Z. Araujo et al.)
93.9% survival rate after 3 years of loading ([5] M. M. Curi et al.)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K163634, External Hex Implants, Southern Implants (Pty) Ltd.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K212785, Blue Sky Bio Implant System, Blue Sky Bio, LLC., K160119, NobelSpeedy Groovy, Nobel Biocare AB, K050406, NobelSpeedy Implants, Nobel Biocare AB, K222457, Provata Implant System, Southern Implants (Pty) Ltd.

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.

April 1, 2024

Southern Implants (Pty) Ltd Jade Rawlins Design Engineer 1 Albert Road Irene, Gauteng 0062 SOUTH AFRICA

Re: K232726

Trade/Device Name: External Hex Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: February 28, 2024 Received: March 4, 2024

Dear Jade Rawlins:

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.

1

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.

2

3

For comprehensive regulatory information about medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

3

Indications for Use

510(k) Number (if known) K232726

Device Name External Hex Implant System

Indications for Use (Describe)

For Standard Length IBR36d Implant Range:

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.

When using Southern Implants' Standard Length IBR36D Implants with angulation of 36° a minimum of 4 implants must be used and splinted

The angled Co-Axis External Hex Implants are intended to be used with straight multiple-unit abutments (Compact Conical abutments) only with no additional angulation allowable on the restoration.

For Extra Length IBR36d Implant Range:

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.

Extra Length IBR36d Implants can be placed bicortically in cases of reduced bone density. Extra Length IBR36d Implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. Extra Length IBR36d Implants are indicated for surgical installation in the ptervgoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.

The angled Co-Axis External Hex Implants are intended to be used with straight multiple-unit abutments (Compact Conical abutments) only with no additional angulation allowable on the restoration.

For Extra Length IBR24d Implant Range:

Southern Implants' External Hex Implants are intended for surgical placement in the upper 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.

Southern Implants' Extra Length IBR24d Implant Range when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

The angled Co-Axis External Hex Implants are intended to be used with straight multiple-unit abutments (Compact Conical abutments) only with no additional angulation allowable on the restoration.

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

External Hex Implant System

Southern Implants (Pty) Ltd

1st April, 2024

ADMINISTRATIVE INFORMATION

| Manufacturer Name | Southern Implants (Pty) Ltd
1 Albert Road
Irene, Gauteng, 0062 South Africa
Telephone: +27 12 667 1046
Fax: +27 12 667 1029 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Jade Rawlins
Design Engineer
Email: jade.r@southernimplants.com |

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	External Hex Implant System
Common Name	Dental implant
Classification Name	Endosseous dental implant
Classification Regulation	21 CFR 872.3640, Class II
Product Code	DZE
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch

PREDICATE DEVICE INFORMATION

Primary predicate devices: K163634, External Hex Implants, Southern Implants (Pty) Ltd.

Reference devices: K212785, Blue Sky Bio Implant System, Blue Sky Bio, LLC. K160119, NobelSpeedy Groovy, Nobel Biocare AB K050406, NobelSpeedy Implants, Nobel Biocare AB K222457, Provata Implant System, Southern Implants (Pty) Ltd.

INDICATIONS FOR USE STATEMENT

For Standard Length IBR36d Implant Range:

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. When using Southern Implants' Standard Length IBR36D Implants with angulation of 36° a minimum of 4 implants must be used and splinted

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The angled Co-Axis External Hex Implants are intended to be used with straight multiple-unit abutments (Compact Conical abutments) only with no additional angulation allowable on the restoration.

For Extra Length IBR36d Implant Range:

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.

Extra Length IBR36d Implants can be placed bicortically in cases of reduced bone density. Extra Length IBR36d Implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. Extra Length IBR36d Implants are indicated for surgical installation in the pterygoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.

The angled Co-Axis External Hex Implants are intended to be used with straight multiple-unit abutments (Compact Conical abutments) only with no additional angulation allowable on the restoration.

For Extra Length IBR24d Implant Range:

Southern Implants' External Hex Implants are intended for surgical placement in the upper 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.

Southern Implants' Extra Length IBR24d Implant Range when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

The angled Co-Axis External Hex Implants are intended to be used with straight multiple-unit abutments (Compact Conical abutments) only with no additional angulation allowable on the restoration.

SUBJECT DEVICE DESCRIPTION

External Hex implants are fully-threaded, tapered, root-form dental implants with an external hexagonal abutment interface, and are threaded internally for attachment of mating multiple-unit abutments, cover screws, or healing abutments. The External Hex implants have a Co-Axis design with the prosthetic platform angled at 36° and 24° (inclined) from orthogonal to the long axis of the implant.

Additionally, the External Hex implants are provided in two configurations, regular surface and MSC surface implants. The regular surface implants are fully roughened excluding a machined collar at the coronal aspect of the implant. The MSC surface implants have an extended length of machined area at the coronal aspect of the implant, with the remaining implant length being roughened.

The implants subject to this submission are the External Hex IBR36d and IBR24d implant range. The reduced platform MSC-IBR24d implants are only provided as Co-Axis implants, in both the regular surface and MSC surface configuration. The reduced platform IBR36d implants are only provided as Co-Axis implants, in regular surface configuration. The IBR36d implants are available in two body configurations depending on the implant length.

The IBR36d implants of overall lengths 8.5 mm to 18 mm have a major body diameter of 4.20 mm tapering to 2.60 mm. The IBR36d implants of overall lengths 20 mm to 24 mm have a major body diameter of 4.20 mm tapering to 2.00 mm. Both the IBR24d and MSC-IBR24d implants of overall lengths 20 mm have a major body diameter 4.07 mm tapering to 2.60 mm. All of the subject device implants utilize the same prosthetic connection, previously cleared in K163634.

All External Hex implants are manufactured from unalloyed titanium (cold-worked, grade 4, UTS ≥ 900 MPa). The MSC-IBR24d implants have a smooth machined surface of length 3 mm extending parallel from the implant prosthetic platform for all implant lengths. The remainder of the implant is grit-blasted with aluminum oxide

7

particles to provide a surface roughness of 1-2 um. The subject device implant material and surface are identical to those of the implants cleared in K163634.

The IBR36d and IBR24d External Hex implants are provided with a dedicated pre-mounted fixture mount of 36° and 24 respectively, similar to that provided with the other Co-Axis External Hex implants cleared in K163634.

All of the subject device implants utilize the same prosthetic connection, previously cleared in K163634 for the External Hex IBR24d and MSC-IBR24d implants. The External Hex implants are used in conjunction with the same abutments cleared for use with the External Hex IBR24d implants (implants cleared in K163634). These abutments are cleared in K053478, K070841, K093562, and K163634. The components that are compatible with the External Hex implants include Cover Screw, Healing Abutment, and Compact Conical Abutments. The Compact Conical Abutments are compatible with Temporary Titanium Abutment Cylinders, Gold Abutment Cylinders, and Passive Abutments.

The subject device Co-Axis implants are indicated for use with straight multiple-unit abutments with a 0° allowable restoration angle, only. This includes restricting straight abutments, that can be restored on a multi-unit abutment, that have an allowable restoration angle of up to 20° associated with them, so that they may only have a restoration angle of 0°. Thus, all the possible compatible abutments will have a 0° allowable restoration angle.

All External Hex implants are provided sterile to the end-user in a single-unit package, and are for single-patient, single-use only.

PERFORMANCE DATA

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility evaluations according to ISO 10993-1 (referenced from K163634); engineering analysis; dimensional analysis; sterilization according to ISO 11137-1, ISO 11137-2, ; bacterial endotoxin according to USP 39-NF 34; and sterile barrier shelf life (referenced from K222457).

Additionally, static and dynamic compression-bending to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants was submitted. Fatigue testing for the subject device External Hex IBR36d and Extra Length IBR24d Implants was conducted on the representative worst-case construct for angulation and abutment/screw materials. For each subject device group, a total of twelve (12) samples were subjected to fatigue testing. The fatigue limit was determined to be where a total of three (3) samples endured 5 x 10° cycles with no failures. Results of mechanical testing performed in conformance to ISO 14801 confirmed that the strength of the subject device is sufficient for its intended use.

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 F2013, ASTM F2182, ASTM F2119) was performed on the previously cleared devices (referenced from K222457). The subject devices were compared to the predicate 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.

CLINICAL DATA

Standard length IBR36d:

A retrospective analysis of real-world clinical data was conducted as a means to support the clinical safety and performance of the Standard length IBR36d, with regards to the angulation of >30° and full scope of proposed indications, including longest implant body lengths, greatest allowed angulation, immediate and delayed loading protocols, splinting across multiple implants, and placement in both upper and lower jaws.

This clinical literature is presented as support for the subject implant's angulation and dimensions as part of this submission. The dimensions of the implants identified in the literature are substantially equivalent or otherwise representative of the subject device (Ø4.2 and lengths of 8.5-18mm).

8

The indications for use for the subject device are in line with those reported on in the literature. These included the indication for use as prosthetic retention method in the rehabilitation of edentulism), suitability for both 1 - and 2- stage surgical techniques (i.e., delayed or immediate loading) based on the user's evaluation, placement in the mandible and maxilla and the requirement for splinting.

The table below outlines the clinical literature submitted in the premarket notification for a determination of substantial equivalence in support of the standard length IBR36d implants. These articles provide information that demonstrates that standard length implants used clinically with an angulation range inclusive of 36° as part of a splinted approach are clinically safe and effective for their intended use.

This clinical data demonstrates that implants with a length of 7-18mm placed within an angulation range of 20-50° as part of a splinted approach present with similar success rates to standard implants. Survival rates and clinical indices were favorable in both maxillary and mandibular applications. Additionally, the data reported on immediate and delayed loading protocols, with favorable results observed in both indications. The standard length IBR36d implants are provided in lengths of 8-18mm and placed at angle of 36°. This is within the window of successful implants identified in the literature.

Extra length IBR36d:

A retrospective analysis of real-world clinical data was conducted as a means to support the clinical safety and performance of the extra length IBR36d, with regards to its full scope of proposed indications, with a specific focus on its longest implant body lengths, greatest allowed angulation, and use in the pterygoid region.

This clinical literature is presented as support for the subject implant's angulation and dimensions as part of this submission. The subject device dimensions (Ø4.2 and lengths of 20-24mm) are substantially equivalent for pterygoid placement.

The extra length IBR36d implants are intended to be used in the pterygoid region of the maxilla as shown in the clinical literature and as shown for the predicate devices in publicly available literature.

The table below outlines the clinical literature submitted in the premarket notification for a determination of substantial equivalence in support of the extra length IBR36d implants. These articles provide information to show that long implants used clinically in the pterygoid region are clinically safe and effective for their intended use.

Implants from 10 – 25 mm in length placed at angles 15 - 90° are used in the pterygoid region with a similar success rate to standard implants. The extra length IBR36d implants are provided in lengths of 20 mm – 24 mm and placed at an angle of 36°. This is within the window of the successful implants identified in the literature.

Conclusion:

The subject device implants with dimensions of Ø4.2mm and lengths of 8 mm - 24 mm do not raise new questions of safety and effectiveness compared to the predicate devices and the clinical literature available.

The standard length IBR36d implants are provided in lengths of 8.5 mm – 18 mm and placed at an angle of 36°. This is within the window of the successful implants identified in the literature. The angulation is smaller than the largest angulation reported where these greater angulations presented with favorable clinical outcomes. Additionally, the survival and success rates reported for angulated implants were consistent with those observed for implants placed under similar clinical conditions The standard length IBR36d implants present similar risks and benefits as angulated implants used in splinted restorations.

The extra length IBR36d implants are provided in lengths of 20 mm - 24 mm, placed at an angle in line with the protocol for pterygoid implant placement and feature a platform angle of 36°. This is within the window of the successful implants identified in the literature. Further, these implants are shorter than those placed in the zygoma which have less bone to implant contact and greater fulcrum force. Therefore, extra length IBR36d implants do not present greater risk than zygomatic implants or other alternative therapies.

9

K232726

Clinical Data for Standard Length IBR36d

Article	Ang. (°)	Length	Diameter	Arch	Loading	FU	Comments	Reference
1	30 - 45	8.5 - 18mm	NM	Both	Immediate	15 y	Survival rates of 97.51% at up to 17 years of function in the maxilla and 96.91% at up to 16 years of function in the mandible. In the maxilla, there was no difference observed between axial and tilted implants in all intervals considered. However, there was significantly less marginal bone loss observed around tilted implants of the mandible with respect to those placed axially, for most of the intervals considered.	E. L. Agliardi, A. Pozzi, D. Romeo, and M. Del Fabbro, "Clinical outcomes of full-arch immediate fixed prostheses supported by two axial and two tilted implants: A retrospective cohort study with 12-15 years of follow-up," Clinical Oral Implants Res, vol. 34, no. 4, pp. 351-366, Apr. 2023, doi: 10.1111/clr.14047.
2	30 - 45	13- 15mm	4mm	Mand.	Immediate	3 y (42 m)	100% survival rate	M. Ayna, A. Gülses, and Y. Acil, "A comparative study on 7-year results of 'All-on-FourTM' immediate-function concept for completely edentulous mandibles: metal-ceramic vs. bar- retained superstructures," Odontology, vol. 106, no. 1, pp. 73-82, Mar. 2017, doi: 10.1007/s10266-017-0304-7.
3	45	11.5 -18 mm	3.5-5.0 mm	Both	Immediate	3 years	Survival rate of 98.7% at 36 months	C. A. Babbush, A. Kanawati, and J. Brokloff, "A New Approach to the All-on-Four Treatment Concept Using Narrow Platform NobelActive Implants," Journal of Oral Implantology, vol. 39, no. 3, pp. 314- 325, Jun. 2013, doi: 10.1563/AAID- JOI-D-12-00223.
4	30 - 45	7 - 18mm	3.3-5mm	Max.	Immediate	5 y	Reported survival rates of 96.1% and 95.7% for tilted and axial implants, respectively. The marginal bone loss difference observed between the axial and tilted implant groups was not statistically significant.	M. Hopp, M. De Araújo Nobre, and P. Maló, "Comparison of marginal bone loss and implant success between axial and tilted implants in maxillary All-on-4 treatment concept rehabilitations after 5 years of follow- up," Clin Implant Dent Rel Res, vol. 19, no. 5, pp. 849-859, Oct. 2017, doi: 10.1111/cid.12526.
5	30 - 45	11 - 15mm	4mm	Mand.	Immediate	1 y	This study reported a high level of implant failures (10%), however; the same number of tilted implants.	R. A. Landázuri-Del Barrio, J. Cosyn, W. N. De Paula, H. De Bruyn, and E.
							and straight implants failed suggesting that the
angulation was not the principal reason for failure.	Marcantonio, "A prospective study on
implants installed with flapless-guided
surgery using the all-on-four concept
in the mandible," Clinical Oral
Implants Res, vol. 24, no. 4, pp. 428-
433, Apr. 2013, doi: 10.1111/j.1600-
0501.2011.02344.x
6	30 - 45	8.5 - 18
mm	4mm	Both	Immediate	5 y	Survival rate of 96.6% after 5 years. Reported a high
level of mechanical complications which were
attributed to the higher than normal incidence of heavy
bruxer patients and had no negative impact on marginal
bone loss or implant survival.	A. Lopes, P. Maló, M. De Araújo
Nobre, and E. Sanchez-Fernández,
"The NobelGuide® All-on-4®
Treatment Concept for Rehabilitation
of Edentulous Jaws: A Prospective
Report on Medium- and Long-Term
Outcomes," Clin Implant Dent Rel
Res, vol. 17, no. S2, Oct. 2015, doi:
10.1111/cid.12260.
7	30 - 45	8.5 -
18mm	4mm	Both	Immediate	7 y	Reported a survival rate of 94.5% after 7 years.	A. Lopes, P. Maló, M. De Araújo
Nobre, E. Sánchez-Fernández, and I.
Gravito, "The NobelGuide All-on-4
Treatment Concept for Rehabilitation
of Edentulous Jaws: A Retrospective
Report on the 7-Years Clinical and 5-
Years Radiographic Outcomes," Clin
Implant Dent Rel Res, vol. 19, no. 2,
pp. 233-244, Apr. 2017, doi:
10.1111/cid.12456.
8	30 - 45	8.5 -
18mm	4mm	Mand.	Immediate	10 y	The implant survival rate at 10 years was 94.8%. This
survival rate accounts for both the axial and tilted
implants; however, less than 50% of the implants that
failed were tilted.	P. Malo, M. De Araújo Nobre, A.
Lopes, S. M. Moss, and G. J. Molina,
"A longitudinal study of the survival
of All-on-4 implants in the mandible
with up to 10 years of follow-up," The
Journal of the American Dental
Association, vol. 142, no. 3, pp. 310-
320, Mar. 2011, doi:
10.14219/jada.archive.2011.0170.
9	10	NM	Both	Immediate	3 y
(42
m)	Survival rate of 100%. The authors observed a yearly
bone loss greater than the accepted level (0.2mm) in
both groups. This was justified by the inclusion of
patients with unfavourable or chronic conditions that
are known to affect the clinical outcome and survival of
dental implants.	Á. L. Szabó et al., "Distally Tilted
Implants According to the All-on-
Four® Treatment Concept for the
Rehabilitation of Complete
Edentulism: A 3.5-Year Retrospective
Radiographic Study of Clinical
Outcomes and Marginal Bone Level
Changes," Dentistry Journal, vol. 10,
no. 5, p. 82, May 2022, doi:
10.3390/dj10050082.

10

11

12

Clinical Data for Extra Length IBR36d

Article	Diameter	Length	Angle	Comment	Reference
1	3.75 - 4.2mm	18 - 25mm	25-45°	As part of the conclusion, it was stated that the use of a "[p]terygoid implant provides a reasonable alternative to 3D maxillary reconstruction, sinus lifts, and bone augmentation technique. Many authors have reported success rates of pterygoid implants ranging from 90% to 100% after follow-up period ranging from 1 to 12 years with minimal complications. Avoidance of a prosthetic distal cantilever with good stability fit for immediate loading is possible with this technique."	P. V. R. Nag, P. Sarika, T. Bhagwatkar, and V. Dhara, "Pterygoid implant: Option for rehabilitation of the atrophic posterior maxilla," International Journal of Contemporary Dental and Medical Reviews, vol. 2019.
2	3.75 -4.0mm where not all diameters	10 - 22mm	35-55°	Thirteen articles were included, reporting a total of 1053 pterygoid implants in 676 patients. The weighted average success of pterygoid implants was 90.7%; bone loss evaluated radiographically ranged between 0 and 4.5 mm. No additional complications compared with conventional implants were	E. Candel, D. Peñarrocha, and M. Peñarrocha, "Rehabilitation of the Atrophic Posterior Maxilla With Pterygoid Implants: A Review," Journal of Oral Implantology,

13

| 3 | 3.75 -
4.2mm | 18-25mm | 25-45° | This retrospective study evaluated implants of varying lengths used in the
TTPHIL pterygoid implant surgery protocol. After 2 years of follow up,
121/125 of the implants were considered successful. Four implants failed
within 2 months of placement and were accompanied by patient's complaints
on pain, prosthetic mobility, bleeding or discomfort. The failures were
confirmed by failed clinical mobility testing. Overall, this study reported a
survival rate of 96.8% at 2 years and bone loss of 0.25 and 0.28mm at 1 and
2 years, respectively. 1 patient had ceramic chipping. | V. P. R. Nag et al., "Minimally Invasive
Reconstruction of Atrophic Maxilla Using
Novel TTPHIL Technique - A Retrospective
Evaluation of Pterygoid Implants and
Prosthesis Success in 75 Patients," Dent Adv
Res, vol. 7, no. 1, Jan.
2022, doi:
10.29011/2574-7347.100086. |
|---|--------------------------------------------------------------------------|--------------|----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4 | Stated as
considered
but not
specified in
the
publication | 13 -
20mm | 15 - 90° | A total of 634 patients received 1.893 pterygoid implants, with a mean
implant survival rate of 94.87%. The mean prevalence of implant failure
was 0.056 with a 95% CI of 0.04 - 0.077. This study demonstrates that
pterygoid implants can be successfully used in patients with atrophic
posterior maxilla | R. Z. Araujo, J. F. Santiago Júnior, C. L.
Cardoso, A. F. Benites Condezo, R.
Moreira Júnior, and M. M. Curi, "Clinical
outcomes of pterygoid implants: Systematic
review and meta-analysis," J
Craniomaxillofac Surg, vol. 47, no. 4, pp.
651-660, Apr. 2019, doi:
10.1016/j.jcms.2019.01.030. |
| 5 | 3.75 -
4.0mm | 18-20mm | 15-60° | This retrospective study reported a survival rate of 93.9% and mean bone
loss of 1.21mm after 3 years of loading. | M. M. Curi, C. L. Cardoso, and K. D. C. B.
Ribeiro, "Retrospective Study of Pterygoid
Implants in the Atrophic Posterior Maxilla:
Implant and Prosthesis Survival Rates Up
to 3 Years," Int J Oral Maxillofac Implants,
vol. 30, no. 2, pp. 378-383, Mar. 2015, doi: 10.11607/jomi.3665. |

14

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 device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

K163634, External Hex Implants, Southern Implants (Pty) Ltd. K160119, NobelSpeedy Groovy, Nobel Biocare AB K212785, Blue Sky Bio Implant System, Blue Sky Bio, LLC. K050406, NobelSpeedy Implants, Nobel Biocare AB

The primary predicate device for the subject device Standard Length IBR36d implants design is K163634. The reference device isK050406.

The primary predicate device for the subject device Extra Length IBR36d implants design is K163634. The reference device is K212785.

The primary predicate device for the subject device Extra Length IBR24d implants is K163634. The reference device is K160119.

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

15

Comparison	Subject Device	Primary Predicate Device	Reference Device
	Standard Length IBR36d Implant
Range	K163634	K212785	K050406
	Southern Implants (Pty) Ltd	External Hex Implants
Southern Implants (Pty) Ltd	Blue Sky Bio Implant System
Blue Sky Bio, LLC	NOBELSPEEDY Implants
Nobel Biocare USA, LLC
Indications for Use
Statement	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.

When using Southern Implants' Standard
Length IBR36D Implants with angulation of
36° a minimum of 4 implants must be used
and splinted.

The angled Co-Axis External Hex Implants
are intended to be used with straight
multiple-unit abutments (Compact Conical
abutments) only with no additional
angulation allowable on the restoration. | 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. | Blue Sky Bio Multi One Implant System is
intended for surgical placement in the bone
of the upper or lower jaw to provide support
for prosthetic devices to restore chewing
function. Implants may be used with single-
stage or two-stage procedures. They can be
loaded immediately when good primary
stability is achieved and with appropriate
occlusal loading.

Blue Sky Bio Multi One Implant System
with a 45° angulation are indicated for
surgical installation in the pterygoid region
only, in cases of severe jaw resorption, in
order to restore patient esthetics and
chewing function. | NobelSpeedy
implants are root-form
endosseous implants intended to be
surgically placed in the bone of the upper or
lower jaw arches to provide support for
prosthetic devices, such as an artificial
tooth, in order to restore patient esthetics
and chewing function. Nobel Biocare's
NobelSpeedy implants are indicated for
single or multiple unit restorations in
splinted or non-splinted applications.
NobelSpeedy implants may be placed
immediately and put into immediate
function providing that initial stability
requirements detailed in the surgical manual
are satisfied.

NobelSpeedy implants are indicated for use
in soft bone or whenever immediate or early
loading is applied. The NobelSpeedy
implants incorporate a groove on the
implant thread and are11refered over
models without the groove in these soft
bone indications because bone forms more
rapidly in the groove than on other parts of
the implant resulting in increased stability
when compared to non-groove implants. In
addition, the NobelSpeedy implants are
preferred in these soft bone indications
because bone formation on the TiUnite®
surface is more rapid and greater than on
machined surface implants resulting in
better maintenance of initial implant
stability, faster and stronger
osseointegration, and higher success rates.

16

	Subject Device	Primary Predicate Device	Reference Device
Comparison	Extra Length IBR36d Implant Range
Southern Implants (Pty) Ltd	K163634
External Hex Implant System
Southern Implants (Pty) Ltd	K212785
Blue Sky Bio Implant System
Blue Sky Bio, LLC
Indications for Use Statement	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.
Extra Length IBR36d Implants can be placed bicortically
in cases of reduced bone density.
Extra Length IBR36d Implants are only indicated for
multiple unit restorations in splinted applications that
utilize at least two implants. Extra Length IBR36d
Implants are indicated for surgical installation in the
pterygoid region only, in cases of severe jaw resorption,
in order to restore patient esthetics and chewing function.
The angled Co-Axis External Hex Implants are intended
to be used with straight multiple-unit abutments (Compact
Conical abutments) only with no additional angulation
allowable on the restoration.	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.	Blue Sky Bio Long Implant System is intended for
surgical placement in the bone of the upper jaw to provide
support for prosthetic devices, such as artificial teeth, to
restore chewing function. Implants may be used with
single-stage or two-stage procedures, and may be loaded
immediately when good primary stability is achieved and
with appropriate occlusal loading. Blue Sky Bio Long
implants can be placed bicortically in cases of reduced
bone density.
Blue Sky Bio Long implants are only indicated for
multiple unit restorations in splinted applications that
utilize at least two implants. Blue Sky Bio Long Implant
System with a 45° angulation are indicated for surgical
installation in the pterygoid region only, in cases of severe
jaw resorption, in order to restore patient esthetics and
chewing function.
Product Code	DZE	DZE	DZE
Intended Use	Functional and esthetic rehabilitation of the edentulous
maxilla.	Functional and esthetic rehabilitation of the edentulous
maxilla.	Functional and esthetic rehabilitation of the edentulous
maxilla.
Reason for Predicate/Reference	Not applicable	Implant Design
External Connection and Prosthetic Diameter
Machined Collar
Material and Surface
Sterility and Usage	Implant Design
Implant Length
Implant Diameter
Platform Angle
Item Code	IBR36d-2X	IBR24d; MSC-IBR24d	Not Provided
Implant Design	Fully threaded tapered root-form dental implants	Fully threaded tapered root-form dental implants	Threaded root-form implant to be used with mating
abutments
Implant Diameter	4.20 mm	4.07 mm	3.7, 4.3, 5.0 mm
Implant Length	20, 22, 24 mm	8.5, 10, 11.5, 13, 15, 18 mm	20, 22.5, 25 mm
Platform Angle, Relative to
orthogonal to implant long axis	36° (inclined)	24° (inclined)	Straight, 12°, 17°, 24°, 30°, 45° (inclined)
(45° in pterygoid placement only)
Implant Prosthetic Diameter	3.43 mm	3.43 mm	Not provided
Machined Collar	Regular implants: 0.6 mm	Regular implants: 0.6 mm
MSC implants: 3 mm	Not provided
Implant Interface	External Hex	External Hex	Internal hex with 12° taper
Internal hex with 45° bevel
Implant Material	Unalloyed titanium (ASTM F67) Grade 4, and UTS ≥
900MPa (cold-worked)	Unalloyed titanium (ASTM F67) Grade 4, and UTS ≥
900MPa (cold-worked)	Ti-6Al-4V titanium alloy
Implant Endosseous Surface	Grit-blasted	Grit-blasted	Grit blasted and acid etched
How Provided
Sterility	Provided sterile	Provided sterile	Provided sterile
Sterilization	Gamma irradiation	Gamma irradiation	Gamma irradiation
Usage	Single-patient, single-use	Single-patient, single-use	Single-patient, single-use

17

18

	Subject Device	Primary Predicate Device	Reference Device
Comparison	Extra Length IBR24d Implant Range
Southern Implants (Pty) Ltd	K163634
External Hex Implant System
Southern Implants (Pty) Ltd	K160119
NobelSpeedy® Groovy
Nobel Biocare LLC
Indications for Use Statement	Southern Implants' External Hex Implants are intended
for surgical placement in the upper 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.
Southern Implants' Extra Length IBR24d Implants allow
also for bi-cortical anchorage in cases of reduced bone
density.
Southern Implants' Extra Length IBR24d Implant Range
when placed in the maxilla are only indicated for multiple
unit restorations in splinted applications that utilize at
least two implants.
The angled Co-Axis External Hex Implants are intended
to be used with straight multiple-unit abutments (Compact
Conical abutments) only with no additional angulation
allowable on the restoration.	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.	NobelSpeedy® Groovy implants are endosseous implants
intended to be surgically placed in the upper or lower jaw
bone for anchoring or supporting tooth replacements to
restore patient esthetics and chewing function.
NobelSpeedy® Groovy implants are indicated for single
or multiple unit restorations in splinted or non-splinted
applications. This can be achieved by a 2- stage or 1-stage
surgical technique in combination with immediate, early
or delayed loading protocols, recognizing sufficient
primary stability and appropriate occlusal loading for the
selected technique. Implants allow also for bi-cortical
anchorage in cases of reduced bone density.
NobelSpeedy® Groovy implants 20, 22, 25 mm when
placed in the maxilla are only indicated for multiple unit
restorations in splinted applications that utilize at least
two implants.
Product Code	DZE	DZE	DZE
Intended Use	Functional and esthetic rehabilitation of the edentulous
mandible and maxilla.	Functional and esthetic rehabilitation of the edentulous
mandible and maxilla.	Functional and esthetic rehabilitation of the edentulous
mandible and maxilla.
Reason for Predicate/Reference	Not applicable	Implant Design
External Connection and Prosthetic Diameter	Implant Length
Implant Design

19

| | | Implant Diameter
Platform Angle
Machined Collar
Material and Surface
Sterility and Usage | |
|----------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Item Code | IBR24d; MSC-IBR24d | IBR24d; MSC-IBR24d | Not provided |
| Implant Design | Fully threaded tapered root-form dental implants | Fully threaded tapered root-form dental implants | Tapered apex with bone cutting flutes, to be used with
mating abutments |
| Implant Diameter | 4.07 mm | 4.07 mm | 4.0 mm |
| Implant Length | 20, 22, 24 mm | 6, 8.5, 10, 11.5, 13, 15, 18 mm | 20, 22, 25 mm |
| Platform Angle, Relative to
orthogonal to implant long axis | 24° (inclined) | 24° (inclined) | 0° (straight) |
| Implant Prosthetic Diameter | 3.43 mm | 3.43 mm | Not provided |
| | | | |
| Machined Collar | Regular implants: 0.6 mm | Regular implants: 0.6 mm | Not provided |
| | MSC implants: 3 mm | MSC implants: 3 mm | |
| | | | |
| Implant Interface | External Hex | External Hex | External Hex |
| Implant Material | Unalloyed titanium (ASTM F67) Grade 4, and UTS ≥
900MPa (cold-worked) | Unalloyed titanium (ASTM F67) Grade 4, and UTS ≥
900MPa (cold-worked) | CP Titanium |
| Implant Endosseous Surface | Grit-blasted | Grit-blasted | TiUnite |
| How Provided | | | |
| Sterility | Provided sterile | Provided sterile | Provided sterile |
| Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| Usage | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use |

20

Subject device Standard Length IBR36d implants

The primary predicate device K163634 is for substantial equivalence of the subject device Standard Length IBR36d implant designs. The subject device implants have a similar indication for use, external hex connection, and lengths as implants cleared in K163634, specifically the IBR24d implants. The primary predicate device K163634 is also for substantial equivalence of the subject device implant material, machined collar length, endosseous surface, usage, sterilization method and packaging shelf life.

The reference device K050406 is for substantial equivalence of the subject device implant platform angle and intended use restriction, indicating that for implants with an angulation of 36° a minimum of 4 implants must be used and splinted. Labeling mitigations were used to address differences in surpical protocol and technological characteristics as compared to predicate devices, to ensure safe and effective use of the subject device.

Subject device Extra Length IBR36d implants

The reference device K212785 is for substantial equivalence of the subject device Extra Length IBR36d implant designs. The reference device K212785 is for substantial equivalence of the subject device implant platform angle and lengths. Although differences in platform angle and lengths exist between the subject device and reference device, the reference device platform angles (17°, 30° and 45°) and implant lengths (20, 22.5 and 25 mm) encompasses the platform angle (36°) and implant lengths (20, 22 and 24 mm) of the subject device, as such the subject device does not represent a worst-case scenario in comparison to the reference device. The primary predicate device K163634 is used for substantial equivalence of the subject device external hex connection, implant material, machined collar length, endosseous surface, usage, sterilization method, packaging shelf life, and indications for use statement, with a restriction limiting the use of these implants to surgical installation in the pterygoid region only, as per the reference device K212785. Labeling mitigations such as were used to address differences in surgical protocol and technological characteristics as compared to predicate devices, to ensure safe and effective use of the subject device.

Subject device Extra Length IBR24d implants

The primary predicate device K163634 is for substantial equivalence of the subject device Extra Length IBR24d implant designs. The subject device implants have a similar indication for use, identical external hex connection, platform angle machined collar, implant material, endosseous surface, usage, sterilization method and packaging as implants in K163634, specifically the IBR24d and MSC-IBR24d implants.

The indications for use of the subject device implants in long lengths (i.e., 20, 22 and 24 mm) is limited to multiple unit restorations in splinted applications that utilize at least two implants, similar to the reference device K160119. Labeling mitigations were used to address differences in surgical and technological characteristics as compared to predicate devices, to ensure safe and effective use of the subject device. The reference device K160119 is for the substantial equivalence of the subject device implant lengths (i.e., length 20, 22 and 24mm).

The subject device implants incorporate the same materials and encompass similar ranges of dimensions as the reference devices cleared in K163634, K212785, K160119, and K050406. The surface treatment applied to the endosseous threads of the subject device implants is identical to that cleared in K163634. All subject device components are for single-patient, single-use, and are provided sterile (the same as the reference devices cleared in K163634, K212785, K160119, and K050406).

Substantial equivalence of the subject device components in terms of biocompatibility is supported by the fact that materials are identical in formulation, processing, component interactions, and storage conditions to the predicate devices in K163634.

In support of substantial equivalence in terms of mechanical performance, dynamic compression-bending testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants was performed. Dynamic testing was performed on worst-case subject device constructs. The results from the testing demonstrated fatigue performance of the subject devices that exceeds its indication.

CONCLUSION

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

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