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:

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.

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.

AI/ML Overview

The provided text describes the 510(k) summary for the "External Hex Implant System" and references performance data to support its substantial equivalence to legally marketed predicate devices. However, it does not contain explicit "acceptance criteria" for the device, nor a study design with specific performance metrics against those criteria in the way typically seen for AI/ML device evaluations.

Instead, the document focuses on demonstrating substantial equivalence based on non-clinical performance data (mechanical testing and biocompatibility) and clinical literature review. The clinical literature review is used to show that similar devices with comparable characteristics (e.g., angulation, length) have proven safe and effective.

Therefore, I cannot directly provide a table of acceptance criteria and reported device performance with specific metrics like sensitivity, specificity, or AUC, as these are not defined or reported in the provided text. The "performance" discussed relates to the device's mechanical strength and the success rates of similar implants documented in clinical literature, not an AI algorithm's diagnostic performance.

However, I can extract the relevant information regarding the studies referenced to support the device's safety and effectiveness, interpreting "acceptance criteria" as the demonstration of substantial equivalence through various assessments:

Interpretation of "Acceptance Criteria" for this device:

For this device, "acceptance criteria" are not quantitative performance metrics in the traditional sense for diagnostic AI. Instead, they are met by demonstrating the device's substantial equivalence to legally marketed predicate devices through:

Biocompatibility: Conformance to ISO 10993-1.
Mechanical Performance: Conformance to ISO 14801 (static and dynamic compression-bending fatigue test), with results showing sufficient strength for intended use.
Sterilization: Conformance to ISO 11137-1, ISO 11137-2, and USP 39-NF 34 for bacterial endotoxin.
Dimensional Analysis: Verification of critical dimensions.
Clinical Safety and Performance (via Literature Review): Demonstrated favorable survival rates and clinical indices for comparable implants under similar conditions and specifications (length, angulation, loading protocols). This implicitly acts as an "acceptance criterion" for clinical effectiveness by showing established safety and effectiveness of similar devices.
MR Safety: Conformance to FDA Guidance Document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" (ASTM F2503, ASTM F2013, ASTM F2182, ASTM F2119).

Summary of Information from the Provided Text:

1. Table of "Acceptance Criteria" (interpreted as equivalence demonstration points) and "Reported Device Performance":

| Area of "Acceptance Criteria" (Demonstration of Equivalence) | Reported Device Performance / Evidence |
| Biocompatibility | Evaluated according to ISO 10993-1 (referenced from K163634). |
| Mechanical Performance (Static & Dynamic Compression-Bending) | Testing to ISO 14801 was performed on representative worst-case constructs for angulation and abutment/screw materials. Twelve (12) samples for each subject device group were subjected to fatigue testing. The fatigue limit was determined to be where a total of three (3) samples endured 5 x 10^6 cycles with no failures. Results confirmed that the strength of the subject device is sufficient for its intended use. |
| Sterilization & Shelf Life | Sterilization according to ISO 11137-1, ISO 11137-2. Bacterial endotoxin according to USP 39-NF 34. Sterile barrier shelf life (referenced from K222457). |
| Dimensional Analysis | Performed. (No specific values reported in this section, but implied to meet design specifications). |
| Clinical Safety & Performance (Standard Length IBR36d) | Retrospective analysis of real-world clinical data (literature review). The literature review demonstrated that implants with lengths of 7-18mm and angulation range of 20-50° as part of a splinted approach showed similar success rates to standard implants. Survival rates and clinical indices were favorable in both maxillary and mandibular applications, with immediate and delayed loading protocols. The subject device (8.5-18mm lengths, 36° angle) falls within this "window of successful implants." |
| Clinical Safety & Performance (Extra Length IBR36d) | Retrospective analysis of real-world clinical data (literature review). The literature review supported the use of long implants (10-25mm) placed at angles of 15-90° in the pterygoid region, showing similar success rates to standard implants. The subject device (20-24mm lengths, 36° angle) falls within this "window of successful implants." |
| MR (Magnetic Resonance) Safety | MR safety testing (ASTM F2503, F2013, F2182, F2119) was performed on previously cleared devices (referenced from K222457). The subject devices are considered equally MR Safe as the predicate devices because they are not worst-case components in terms of material, size, or shape. |

2. Sample Size and Data Provenance for Test Set (Clinical Literature Review):

Standard Length IBR36d: A retrospective analysis of real-world clinical data was conducted by reviewing 14 clinical literature articles.
- Sample Size (Patients/Implants, per article):
  - Article 1: Not specified, but follow-up up to 17 years.
  - Article 2: Not specified (100% survival rate), follow-up 3 years (42 months).
  - Article 3: Not specified (98.7% survival rate), follow-up 3 years.
  - Article 4: Not specified (96.1% and 95.7% survival rates), follow-up 5 years.
  - Article 5: "High level of implant failures (10%), however; the same number of tilted implants and straight implants failed." Follow-up 1 year.
  - Article 6: Not specified (96.6% survival rate), follow-up 5 years.
  - Article 7: Not specified (94.5% survival rate), follow-up 7 years.
  - Article 8: Not specified (94.8% survival rate), follow-up 10 years.
  - Article 9: Not specified (98.1% for tilted implants), follow-up 3 years.
  - Article 10: Not specified (93.9% cumulative survival rate), follow-up 5-13 years.
  - Article 11: Not specified (93% survival rate), follow-up 18 years.
  - Article 12: Not specified (100% survival rate for tilted implants), follow-up 13 months.
  - Article 13: Not specified, follow-up 3 years (42 months).
  - Article 14: Not specified (100% survival rate), follow-up 3 years (42 months).
  - Note: Specific sample sizes (number of patients or implants) for each referenced article are generally not provided in the summary, which is common for literature reviews used in 510(k) submissions to support equivalence.
- Data Provenance: Retrospective analysis of real-world clinical data (published literature). The country of origin of the data is not specified for individual studies but can be inferred from the journal names and author affiliations in the references (e.g., Clinical Oral Implants Research, Odontology, Journal of Oral Implantology, Clin Implant Dent Rel Res, European Journal of Oral Implantology, The Journal of the American Dental Association, Dentistry Journal).
Extra Length IBR36d: A retrospective analysis of real-world clinical data was conducted by reviewing 5 clinical literature articles.
- Sample Size (Patients/Implants, per article):
  - Article 1: "Many authors have reported success rates of pterygoid implants ranging from 90% to 100% after follow-up period ranging from 1 to 12 years."
  - Article 2: "Thirteen articles were included, reporting a total of 1053 pterygoid implants in 676 patients."
  - Article 3: "121/125 of the implants were considered successful" after 2 years.
  - Article 4: "A total of 634 patients received 1,893 pterygoid implants."
  - Article 5: Not specified (93.9% survival rate), follow-up 3 years.
- Data Provenance: Retrospective analysis of real-world clinical data (published literature). The country of origin of the data is not specified for individual studies but can be inferred from the journal names and author affiliations in the references (e.g., International Journal of Contemporary Dental and Medical Reviews, Journal of Oral Implantology, Dent Adv Res, Journal of Craniomaxillofacial Surgery, International Journal of Oral Maxillofacial Implants).

3. Number of Experts and Qualifications for Ground Truth: No direct "ground truth" establishment by experts for specific cases in the context of an AI algorithm is mentioned in this document. The clinical studies cited in the literature review represent real-world clinical outcomes and expert clinical practice by the authors of those papers. Their original reports would have involved clinical expertise to determine success/failure, bone loss, etc.

4. Adjudication Method: Not applicable. This document relies on published clinical literature, not an internal test set requiring adjudication for ground truth. The adjudication method, if any, would have been part of each individual study in the literature review.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This document does not pertain to an AI algorithm or human-in-the-loop performance. It describes a physical dental implant device.

6. Standalone (Algorithm Only) Performance Study: No. This document describes a physical dental implant device, not an algorithm.

7. Type of Ground Truth Used (for Clinical Performance): The "ground truth" for the clinical performance claims is derived from real-world clinical outcomes data reported in the referenced scientific literature. This includes:
* Implant survival rates
* Marginal bone loss (MBL)
* Clinical indices (e.g., pain, prosthetic mobility, bleeding, discomfort)
* Success rates of implants under various loading protocols (immediate/delayed) and angulations.

8. Sample Size for the Training Set: Not applicable. This document describes a physical dental implant system, not a machine learning model that requires a training set. The "training" for the device's design would be engineering principles, material science, and clinical experience/literature.

9. How the Ground Truth for the Training Set was Established: Not applicable, as it's not an AI/ML device.

Summary

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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.

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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 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

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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:

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:

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' 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) Ltd1 Albert RoadIrene, Gauteng, 0062 South AfricaTelephone: +27 12 667 1046Fax: +27 12 667 1029
Official Contact	Jade RawlinsDesign EngineerEmail: 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:

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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:

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' 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

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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.

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).

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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.

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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 theangulation was not the principal reason for failure.	Marcantonio, "A prospective study onimplants installed with flapless-guidedsurgery using the all-on-four conceptin the mandible," Clinical OralImplants Res, vol. 24, no. 4, pp. 428-433, Apr. 2013, doi: 10.1111/j.1600-0501.2011.02344.x
6	30 - 45	8.5 - 18mm	4mm	Both	Immediate	5 y	Survival rate of 96.6% after 5 years. Reported a highlevel of mechanical complications which wereattributed to the higher than normal incidence of heavybruxer patients and had no negative impact on marginalbone loss or implant survival.	A. Lopes, P. Maló, M. De AraújoNobre, and E. Sanchez-Fernández,"The NobelGuide® All-on-4®Treatment Concept for Rehabilitationof Edentulous Jaws: A ProspectiveReport on Medium- and Long-TermOutcomes," Clin Implant Dent RelRes, 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 AraújoNobre, E. Sánchez-Fernández, and I.Gravito, "The NobelGuide All-on-4Treatment Concept for Rehabilitationof Edentulous Jaws: A RetrospectiveReport on the 7-Years Clinical and 5-Years Radiographic Outcomes," ClinImplant 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%. Thissurvival rate accounts for both the axial and tiltedimplants; however, less than 50% of the implants thatfailed were tilted.	P. Malo, M. De Araújo Nobre, A.Lopes, S. M. Moss, and G. J. Molina,"A longitudinal study of the survivalof All-on-4 implants in the mandiblewith up to 10 years of follow-up," TheJournal of the American DentalAssociation, vol. 142, no. 3, pp. 310-320, Mar. 2011, doi:10.14219/jada.archive.2011.0170.
9	<45	13 -18mm	4mm	Max.	Immediate	10 y	Survival rate of 98.1% for tilted implants at 3 years. Afavorable level of bone loss was observed for tiltedimplants based on the Albrektsson criteria.	P. Maló, M. de A. Nobre, and A.Lopes, "Immediate loading of 'All-on-4' maxillary prostheses using trans-
								sinus tilted implants without sinusbone grafting: a retrospective studyreporting the 3-year outcome," Eur JOral Implantol, vol. 6, no. 3, pp. 219-226, 2013.
10	30 - 45	7 –18mm	3.3-5mm	Max.	Immediate	13 y	Cumulative survival rate of 93.9% and favourablelevels of MBL.	P. Maló, M. De Araújo Nobre, A.Lopes, A. Ferro, and M. Nunes, "TheAll-on-4 concept for full-archrehabilitation of the edentulousmaxillae: A longitudinal study with 5-13 years of follow-up," Clin ImplantDent Rel Res, vol. 21, no. 4, pp. 538-549, Aug. 2019, doi:10.1111/cid.12771.
11	≈45	8.5-18mm	3.75mm	Max.	Immediate	18 y	Survival rate of 93% after 18 years. There was anincreased density of failures observed following the 10year follow-up which was partially explained by theadvancing age of the population and the associateddecrease in oral health practices and overall well-being.However, the observed survival rate of 93% at 18 yearsis higher than the acceptable level of survival oftitanium implants proposed by Albrektsson of 91% at15 years.	P. Maló, M. De Araújo Nobre, A.Lopes, A. Ferro, and J. Botto, "TheAll-on-4 treatment concept for therehabilitation of the completelyedentulous mandible: A longitudinalstudy with 10 to 18 years of follow-up," Clin Implant Dent Rel Res, vol.21, no. 4, pp. 565-577, Aug. 2019,doi: 10.1111/cid.12769.
12	45	NM	NM	Both	Immediateanddelayed	13 m	100% survival rate for tilted implants.The marginal bone loss difference observed betweenthe axial and tilted implant groups was not statisticallysignificant.	H. Najafi, H. Siadat, S. Akbari, and A.Rokn, "Effects of Immediate andDelayed Loading on the Outcomes ofAll-on-4 Treatment: A ProspectiveStudy," Journal of Dentistry (Tehran),vol. 13, no. 6, pp. 415-422.
13	20 - 40	10-15mm	3.5-4.3mm	Mand.	Immediate	3 y(42m)	No statistically significant difference was observed inmarginal bone resorption or survival rates of the axialand tilted implant.	G. Sannino and A. Barlattani,"Straight Versus AngulatedAbutments on Tilted Implants inImmediate Fixed Rehabilitation of theEdentulous Mandible: A 3-YearRetrospective Comparative Study,"Int J Prosthodont, vol. 29, no. 3, pp.219-226, May 2016, doi:10.11607/ijp.4448
14	≤45	>10	NM	Both	Immediate	3 y(42m)	Survival rate of 100%. The authors observed a yearlybone loss greater than the accepted level (0.2mm) inboth groups. This was justified by the inclusion ofpatients with unfavourable or chronic conditions thatare known to affect the clinical outcome and survival ofdental implants.	Á. L. Szabó et al., "Distally TiltedImplants According to the All-on-Four® Treatment Concept for theRehabilitation of CompleteEdentulism: A 3.5-Year RetrospectiveRadiographic Study of ClinicalOutcomes and Marginal Bone LevelChanges," Dentistry Journal, vol. 10,no. 5, p. 82, May 2022, doi:10.3390/dj10050082.

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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,

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3	3.75 -4.2mm	18-25mm	25-45°	This retrospective study evaluated implants of varying lengths used in theTTPHIL pterygoid implant surgery protocol. After 2 years of follow up,121/125 of the implants were considered successful. Four implants failedwithin 2 months of placement and were accompanied by patient's complaintson pain, prosthetic mobility, bleeding or discomfort. The failures wereconfirmed by failed clinical mobility testing. Overall, this study reported asurvival rate of 96.8% at 2 years and bone loss of 0.25 and 0.28mm at 1 and2 years, respectively. 1 patient had ceramic chipping.	V. P. R. Nag et al., "Minimally InvasiveReconstruction of Atrophic Maxilla UsingNovel TTPHIL Technique - A RetrospectiveEvaluation of Pterygoid Implants andProsthesis Success in 75 Patients," Dent AdvRes, vol. 7, no. 1, Jan.2022, doi:10.29011/2574-7347.100086.
4	Stated asconsideredbut notspecified inthepublication	13 -20mm	15 - 90°	A total of 634 patients received 1.893 pterygoid implants, with a meanimplant survival rate of 94.87%. The mean prevalence of implant failurewas 0.056 with a 95% CI of 0.04 - 0.077. This study demonstrates thatpterygoid implants can be successfully used in patients with atrophicposterior maxilla	R. Z. Araujo, J. F. Santiago Júnior, C. L.Cardoso, A. F. Benites Condezo, R.Moreira Júnior, and M. M. Curi, "Clinicaloutcomes of pterygoid implants: Systematicreview and meta-analysis," JCraniomaxillofac 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 boneloss of 1.21mm after 3 years of loading.	M. M. Curi, C. L. Cardoso, and K. D. C. B.Ribeiro, "Retrospective Study of PterygoidImplants in the Atrophic Posterior Maxilla:Implant and Prosthesis Survival Rates Upto 3 Years," Int J Oral Maxillofac Implants,vol. 30, no. 2, pp. 378-383, Mar. 2015, doi: 10.11607/jomi.3665.

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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.

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Comparison	Subject Device	Primary Predicate Device	Reference Device	Reference Device
	Standard Length IBR36d ImplantRange	K163634	K212785	K050406
	Southern Implants (Pty) Ltd	External Hex ImplantsSouthern Implants (Pty) Ltd	Blue Sky Bio Implant SystemBlue Sky Bio, LLC	NOBELSPEEDY ImplantsNobel Biocare USA, LLC
Indications for UseStatement	Southern Implants' External Hex Implantsare intended for surgical placement in theupper or lower jaw to provide a means forprosthetic attachment of crowns, bridges oroverdentures utilizing delayed or immediateloading. Southern Implants' External HexImplants are intended for immediatefunction when good primary stability withappropriate occlusal loading is achieved.When using Southern Implants' StandardLength IBR36D Implants with angulation of36° a minimum of 4 implants must be usedand splinted.The angled Co-Axis External Hex Implantsare intended to be used with straightmultiple-unit abutments (Compact Conicalabutments) only with no additionalangulation allowable on the restoration.	Southern Implants' External Hex Implantsare intended for surgical placement in theupper or lower jaw to provide a means forprosthetic attachment of crowns, bridges oroverdentures utilizing delayed or immediateloading. Southern Implants' External HexImplants are intended for immediatefunction when good primary stability withappropriate occlusal loading is achieved.	Blue Sky Bio Multi One Implant System isintended for surgical placement in the boneof the upper or lower jaw to provide supportfor prosthetic devices to restore chewingfunction. Implants may be used with single-stage or two-stage procedures. They can beloaded immediately when good primarystability is achieved and with appropriateocclusal loading.Blue Sky Bio Multi One Implant Systemwith a 45° angulation are indicated forsurgical installation in the pterygoid regiononly, in cases of severe jaw resorption, inorder to restore patient esthetics andchewing function.	NobelSpeedyimplants are root-formendosseous implants intended to besurgically placed in the bone of the upper orlower jaw arches to provide support forprosthetic devices, such as an artificialtooth, in order to restore patient estheticsand chewing function. Nobel Biocare'sNobelSpeedy implants are indicated forsingle or multiple unit restorations insplinted or non-splinted applications.NobelSpeedy implants may be placedimmediately and put into immediatefunction providing that initial stabilityrequirements detailed in the surgical manualare satisfied.NobelSpeedy implants are indicated for usein soft bone or whenever immediate or earlyloading is applied. The NobelSpeedyimplants incorporate a groove on theimplant thread and are11refered overmodels without the groove in these softbone indications because bone forms morerapidly in the groove than on other parts ofthe implant resulting in increased stabilitywhen compared to non-groove implants. Inaddition, the NobelSpeedy implants arepreferred in these soft bone indicationsbecause bone formation on the TiUnite®surface is more rapid and greater than onmachined surface implants resulting inbetter maintenance of initial implantstability, faster and strongerosseointegration, and higher success rates.NobelSpeedy implants may be tilted up to45°. When used with angulations between30° and 45° a minimum of 4 implants mustbe used and splinted.
Product Code	DZE	DZE	DZE	DZE
Intended Use	Functional and esthetic rehabilitation of theedentulous mandible and maxilla.	Functional and esthetic rehabilitation of theedentulous mandible and maxilla.	Functional and esthetic rehabilitation of theedentulous mandible and maxilla.	Functional and esthetic rehabilitation of theedentulous mandible and maxilla.
Reason forPredicate/Reference	Not applicable	Implant LengthImplant DesignExternal Connection and ProstheticDiameterMachined CollarMaterial and SurfaceSterility and Usage	Implant DesignImplant DiameterPlatform Angle	Implant AngulationIndications for use restriction of 4 implantsto be used and splinted.
Item Code	IBR36d	IBR24d; MSC-IBR24d	Not provided	Not provided
Implant Design	Fully threaded tapered root-form dentalimplants	Fully threaded tapered root-form dentalimplants	One-piece implant/abutment	Tapered apex with bone cutting flutes
Implant Diameter	4.20 mm	4.07 mm	3.0, 3.25, 3.5, 3.7 4.3 mm	Not provided
Implant Length	8.5, 10, 11.5, 13, 15, 18 mm	8.5, 10, 11.5, 13, 15, 18 mm	10, 11.5, 13, 16, 18, 20 mm	7, 8.5, 10, 11.5, 13, 15, 18 mm
Platform Angle, Relativeto orthogonal to implantlong axis	36° (inclined)	24° (inclined)	Straight, 17°, 30°, 45° (inclined)(45° in pterygoid placement only)	NobelSpeedy implants may be tilted up to450.
Implant ProstheticDiameter	3.43 mm	3.43 mm	Not provided	Not provided
Machined Collar	Regular implants: 0.6 mm	Regular implants: 0.6 mmMSC implants: 3 mm	Not provided	Not provided
Implant Interface	External Hex	External Hex	One Piece	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)	Ti-6Al-4V titanium alloy	CP Titanium
Implant EndosseousSurface	Grit-blasted	Grit-blasted	Grit blasted and acid etched	TiUnite
Sterility	Provided sterile	Provided sterile	Provided sterile	Provided sterile
Sterilization	Gamma irradiation	Gamma irradiation	Gamma irradiation	Gamma irradiation
Usage	Single-patient, single-use	Single-patient, single-use	Single-patient, single-use	Single-patient, single-use

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	Subject Device	Primary Predicate Device	Reference Device
Comparison	Extra Length IBR36d Implant RangeSouthern Implants (Pty) Ltd	K163634External Hex Implant SystemSouthern Implants (Pty) Ltd	K212785Blue Sky Bio Implant SystemBlue Sky Bio, LLC
Indications for Use Statement	Southern Implants' External Hex Implants are intendedfor surgical placement in the upper or lower jaw toprovide a means for prosthetic attachment of crowns,bridges or overdentures utilizing delayed or immediateloading. Southern Implants' External Hex Implants areintended for immediate function when good primarystability with appropriate occlusal loading is achieved.Extra Length IBR36d Implants can be placed bicorticallyin cases of reduced bone density.Extra Length IBR36d Implants are only indicated formultiple unit restorations in splinted applications thatutilize at least two implants. Extra Length IBR36dImplants are indicated for surgical installation in thepterygoid 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 intendedto be used with straight multiple-unit abutments (CompactConical abutments) only with no additional angulationallowable on the restoration.	Southern Implants' External Hex Implants are intendedfor surgical placement in the upper or lower jaw toprovide a means for prosthetic attachment of crowns,bridges or overdentures utilizing delayed or immediateloading. Southern Implants' External Hex Implants areintended for immediate function when good primarystability with appropriate occlusal loading is achieved.	Blue Sky Bio Long Implant System is intended forsurgical placement in the bone of the upper jaw to providesupport for prosthetic devices, such as artificial teeth, torestore chewing function. Implants may be used withsingle-stage or two-stage procedures, and may be loadedimmediately when good primary stability is achieved andwith appropriate occlusal loading. Blue Sky Bio Longimplants can be placed bicortically in cases of reducedbone density.Blue Sky Bio Long implants are only indicated formultiple unit restorations in splinted applications thatutilize at least two implants. Blue Sky Bio Long ImplantSystem with a 45° angulation are indicated for surgicalinstallation in the pterygoid region only, in cases of severejaw resorption, in order to restore patient esthetics andchewing function.
Product Code	DZE	DZE	DZE
Intended Use	Functional and esthetic rehabilitation of the edentulousmaxilla.	Functional and esthetic rehabilitation of the edentulousmaxilla.	Functional and esthetic rehabilitation of the edentulousmaxilla.
Reason for Predicate/Reference	Not applicable	Implant DesignExternal Connection and Prosthetic DiameterMachined CollarMaterial and SurfaceSterility and Usage	Implant DesignImplant LengthImplant DiameterPlatform 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 matingabutments
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 toorthogonal 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 mmMSC implants: 3 mm	Not provided
Implant Interface	External Hex	External Hex	Internal hex with 12° taperInternal 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

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	Subject Device	Primary Predicate Device	Reference Device
Comparison	Extra Length IBR24d Implant RangeSouthern Implants (Pty) Ltd	K163634External Hex Implant SystemSouthern Implants (Pty) Ltd	K160119NobelSpeedy® GroovyNobel Biocare LLC
Indications for Use Statement	Southern Implants' External Hex Implants are intendedfor surgical placement in the upper jaw to provide a meansfor prosthetic attachment of crowns, bridges oroverdentures utilizing delayed or immediate loading.Southern Implants' External Hex Implants are intendedfor immediate function when good primary stability withappropriate occlusal loading is achieved.Southern Implants' Extra Length IBR24d Implants allowalso for bi-cortical anchorage in cases of reduced bonedensity.Southern Implants' Extra Length IBR24d Implant Rangewhen placed in the maxilla are only indicated for multipleunit restorations in splinted applications that utilize atleast two implants.The angled Co-Axis External Hex Implants are intendedto be used with straight multiple-unit abutments (CompactConical abutments) only with no additional angulationallowable on the restoration.	Southern Implants' External Hex Implants are intendedfor surgical placement in the upper or lower jaw toprovide a means for prosthetic attachment of crowns,bridges or overdentures utilizing delayed or immediateloading. Southern Implants' External Hex Implants areintended for immediate function when good primarystability with appropriate occlusal loading is achieved.	NobelSpeedy® Groovy implants are endosseous implantsintended to be surgically placed in the upper or lower jawbone for anchoring or supporting tooth replacements torestore patient esthetics and chewing function.NobelSpeedy® Groovy implants are indicated for singleor multiple unit restorations in splinted or non-splintedapplications. This can be achieved by a 2- stage or 1-stagesurgical technique in combination with immediate, earlyor delayed loading protocols, recognizing sufficientprimary stability and appropriate occlusal loading for theselected technique. Implants allow also for bi-corticalanchorage in cases of reduced bone density.NobelSpeedy® Groovy implants 20, 22, 25 mm whenplaced in the maxilla are only indicated for multiple unitrestorations in splinted applications that utilize at leasttwo implants.
Product Code	DZE	DZE	DZE
Intended Use	Functional and esthetic rehabilitation of the edentulousmandible and maxilla.	Functional and esthetic rehabilitation of the edentulousmandible and maxilla.	Functional and esthetic rehabilitation of the edentulousmandible and maxilla.
Reason for Predicate/Reference	Not applicable	Implant DesignExternal Connection and Prosthetic Diameter	Implant LengthImplant Design

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		Implant DiameterPlatform AngleMachined CollarMaterial and SurfaceSterility 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 withmating 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 toorthogonal 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

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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.

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.