External Hex Implant System

K232726 · Southern Implants (Pty), Ltd. · DZE · Apr 1, 2024 · Dental

Device Facts

Record IDK232726
Device NameExternal Hex Implant System
ApplicantSouthern Implants (Pty), Ltd.
Product CodeDZE · Dental
Decision DateApr 1, 2024
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

Intended Use

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

Device Story

External Hex Implant System consists of fully-threaded, tapered, root-form dental implants with external hexagonal interface; internal threading for abutments/screws. Features Co-Axis design with prosthetic platform angled at 24° or 36°. Available in regular surface or MSC (machined collar) configurations. Used by dental surgeons in clinical settings for prosthetic rehabilitation of edentulous jaws. Implants placed in upper/lower jaw; provide anchorage for crowns, bridges, or overdentures. Immediate loading possible with sufficient primary stability. Extra length variants used for bicortical anchorage or pterygoid region placement. Healthcare providers use output (implant platform) to attach prosthetic components. Benefits include restoration of patient esthetics and chewing function.

Clinical Evidence

Retrospective analysis of clinical literature provided. Standard length IBR36d supported by 14 studies (n=varied) showing survival rates 93-100% for angulated/tilted implants in splinted full-arch rehabilitations. Extra length IBR36d supported by 5 studies (n=1053 implants) showing 90-100% success rates for pterygoid placement. Bench testing included ISO 14801 dynamic fatigue testing on worst-case constructs (12 samples/group, 5x10^6 cycles).

Technological Characteristics

Material: Unalloyed titanium (ASTM F67, Grade 4, UTS ≥ 900 MPa). Surface: Grit-blasted (1-2 um roughness) with machined collar (0.6mm or 3mm). Interface: External Hex. Sterilization: Gamma irradiation. Connectivity: Mechanical interface for abutments. Form factor: Tapered root-form, 4.2mm diameter, 8.5-24mm lengths.

Indications for Use

Indicated for surgical placement in upper or lower jaw for prosthetic attachment of crowns, bridges, or overdentures in edentulous patients. Supports delayed or immediate loading. Standard Length IBR36d (36° angulation) requires minimum 4 splinted implants. Extra Length IBR36d indicated for bicortical placement in reduced bone density, multiple unit splinted restorations (min 2 implants), and pterygoid region placement for severe jaw resorption. Extra Length IBR24d indicated for multiple unit splinted restorations (min 2 implants) in maxilla. Contraindicated for non-splinted applications for extra length variants.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ 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) {4}------------------------------------------------ # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ # 510(k) Summary # External Hex Implant System ## Southern Implants (Pty) Ltd # 1st April, 2024 ## ADMINISTRATIVE INFORMATION | Manufacturer Name | Southern Implants (Pty) Ltd<br>1 Albert Road<br>Irene, Gauteng, 0062 South Africa<br>Telephone: +27 12 667 1046<br>Fax: +27 12 667 1029 | |-------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | Official Contact | Jade Rawlins<br>Design Engineer<br>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 {6}------------------------------------------------ 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<br>angulation was not the principal reason for failure. | Marcantonio, "A prospective study on<br>implants installed with flapless-guided<br>surgery using the all-on-four concept<br>in the mandible," Clinical Oral<br>Implants Res, vol. 24, no. 4, pp. 428-<br>433, Apr. 2013, doi: 10.1111/j.1600-<br>0501.2011.02344.x | | 6 | 30 - 45 | 8.5 - 18<br>mm | 4mm | Both | Immediate | 5 y | Survival rate of 96.6% after 5 years. Reported a high<br>level of mechanical complications which were<br>attributed to the higher than normal incidence of heavy<br>bruxer patients and had no negative impact on marginal<br>bone loss or implant survival. | A. Lopes, P. Maló, M. De Araújo<br>Nobre, and E. Sanchez-Fernández,<br>"The NobelGuide® All-on-4®<br>Treatment Concept for Rehabilitation<br>of Edentulous Jaws: A Prospective<br>Report on Medium- and Long-Term<br>Outcomes," Clin Implant Dent Rel<br>Res, vol. 17, no. S2, Oct. 2015, doi:<br>10.1111/cid.12260. | | 7 | 30 - 45 | 8.5 -<br>18mm | 4mm | Both | Immediate | 7 y | Reported a survival rate of 94.5% after 7 years. | A. Lopes, P. Maló, M. De Araújo<br>Nobre, E. Sánchez-Fernández, and I.<br>Gravito, "The NobelGuide All-on-4<br>Treatment Concept for Rehabilitation<br>of Edentulous Jaws: A Retrospective<br>Report on the 7-Years Clinical and 5-<br>Years Radiographic Outcomes," Clin<br>Implant Dent Rel Res, vol. 19, no. 2,<br>pp. 233-244, Apr. 2017, doi:<br>10.1111/cid.12456. | | 8 | 30 - 45 | 8.5 -<br>18mm | 4mm | Mand. | Immediate | 10 y | The implant survival rate at 10 years was 94.8%. This<br>survival rate accounts for both the axial and tilted<br>implants; however, less than 50% of the implants that<br>failed were tilted. | P. Malo, M. De Araújo Nobre, A.<br>Lopes, S. M. Moss, and G. J. Molina,<br>"A longitudinal study of the survival<br>of All-on-4 implants in the mandible<br>with up to 10 years of follow-up," The<br>Journal of the American Dental<br>Association, vol. 142, no. 3, pp. 310-<br>320, Mar. 2011, doi:<br>10.14219/jada.archive.2011.0170. | | 9 | <45 | 13 -<br>18mm | 4mm | Max. | Immediate | 10 y | Survival rate of 98.1% for tilted implants at 3 years. A<br>favorable level of bone loss was observed for tilted<br>implants based on the Albrektsson criteria. | P. Maló, M. de A. Nobre, and A.<br>Lopes, "Immediate loading of 'All-on-<br>4' maxillary prostheses using trans- | | | | | | | | | | sinus tilted implants without sinus<br>bone grafting: a retrospective study<br>reporting the 3-year outcome," Eur J<br>Oral Implantol, vol. 6, no. 3, pp. 219-<br>226, 2013. | | 10 | 30 - 45 | 7 –<br>18mm | 3.3-5mm | Max. | Immediate | 13 y | Cumulative survival rate of 93.9% and favourable<br>levels of MBL. | P. Maló, M. De Araújo Nobre, A.<br>Lopes, A. Ferro, and M. Nunes, "The<br>All-on-4 concept for full-arch<br>rehabilitation of the edentulous<br>maxillae: A longitudinal study with 5-<br>13 years of follow-up," Clin Implant<br>Dent Rel Res, vol. 21, no. 4, pp. 538-<br>549, Aug. 2019, doi:<br>10.1111/cid.12771. | | 11 | ≈45 | 8.5-<br>18mm | 3.75mm | Max. | Immediate | 18 y | Survival rate of 93% after 18 years. There was an<br>increased density of failures observed following the 10<br>year follow-up which was partially explained by the<br>advancing age of the population and the associated<br>decrease in oral health practices and overall well-being.<br>However, the observed survival rate of 93% at 18 years<br>is higher than the acceptable level of survival of<br>titanium implants proposed by Albrektsson of 91% at<br>15 years. | P. Maló, M. De Araújo Nobre, A.<br>Lopes, A. Ferro, and J. Botto, "The<br>All-on-4 treatment concept for the<br>rehabilitation of the completely<br>edentulous mandible: A longitudinal<br>study with 10 to 18 years of follow-<br>up," Clin Implant Dent Rel Res, vol.<br>21, no. 4, pp. 565-577, Aug. 2019,<br>doi: 10.1111/cid.12769. | | 12 | 45 | NM | NM | Both | Immediate<br>and<br>delayed | 13 m | 100% survival rate for tilted implants.<br>The marginal bone loss difference observed between<br>the axial and tilted implant groups was not statistically<br>significant. | H. Najafi, H. Siadat, S. Akbari, and A.<br>Rokn, "Effects of Immediate and<br>Delayed Loading on the Outcomes of<br>All-on-4 Treatment: A Prospective<br>Study," Journal of Dentistry (Tehran),<br>vol. 13, no. 6, pp. 415-422. | | 13 | 20 - 40 | 10-<br>15mm | 3.5-<br>4.3mm | Mand. | Immediate | 3 y<br>(42<br>m) | No statistically significant difference was observed in<br>marginal bone resorption or survival rates of the axial<br>and tilted implant. | G. Sannino and A. Barlattani,<br>"Straight Versus Angulated<br>Abutments on Tilted Implants in<br>Immediate Fixed Rehabilitation of the<br>Edentulous Mandible: A 3-Year<br>Retrospective Comparative Study,"<br>Int J Prosthodont, vol. 29, no. 3, pp.<br>219-226, May 2016, doi:<br>10.11607/ijp.4448 | | 14 | ≤45 | >10 | NM | Both | Immediate | 3 y<br>(42<br>m) | Survival rate of 100%. The authors observed a yearly<br>bone loss greater than the accepted level (0.2mm) in<br>both groups. This was justified by the inclusion of<br>patients with unfavourable or chronic conditions that<br>are known to affect the clinical outcome and survival of<br>dental implants. | Á. L. Szabó et al., "Distally Tilted<br>Implants According to the All-on-<br>Four® Treatment Concept for the<br>Rehabilitation of Complete<br>Edentulism: A 3.5-Year Retrospective<br>Radiographic Study of Clinical<br>Outcomes and Marginal Bone Level<br>Changes," Dentistry Journal, vol. 10,<br>no. 5, p. 82, May 2022, doi:<br>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 -<br>4.2mm | 18-25mm | 25-45° | This retrospective study evaluated implants of varying lengths used in the<br>TTPHIL pterygoid implant surgery protocol. After 2 years of follow up,<br>121/125 of the implants were considered successful. Four implants failed<br>within 2 months of placement and were accompanied by patient's complaints<br>on pain, prosthetic mobility, bleeding or discomfort. The failures were<br>confirmed by failed clinical mobility testing. Overall, this study reported a<br>survival rate of 96.8% at 2 years and bone loss of 0.25 and 0.28mm at 1 and<br>2 years, respectively. 1 patient had ceramic chipping. | V. P. R. Nag et al., "Minimally Invasive<br>Reconstruction of Atrophic Maxilla Using<br>Novel TTPHIL Technique - A Retrospective<br>Evaluation of Pterygoid Implants and<br>Prosthesis Success in 75 Patients," Dent Adv<br>Res, vol. 7, no. 1, Jan.<br>2022, doi:<br>10.29011/2574-7347.100086. | |---|--------------------------------------------------------------------------|--------------|----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 4 | Stated as<br>considered<br>but not<br>specified in<br>the<br>publication | 13 -<br>20mm | 15 - 90° | A total of 634 patients received 1.893 pterygoid implants, with a mean<br>implant survival rate of 94.87%. The mean prevalence of implant failure<br>was 0.056 with a 95% CI of 0.04 - 0.077. This study demonstrates that<br>pterygoid implants can be successfully used in patients with atrophic<br>posterior maxilla | R. Z. Araujo, J. F. Santiago Júnior, C. L.<br>Cardoso, A. F. Benites Condezo, R.<br>Moreira Júnior, and M. M. Curi, "Clinical<br>outcomes of pterygoid implants: Systematic<br>review and meta-analysis," J<br>Craniomaxillofac Surg, vol. 47, no. 4, pp.<br>651-660, Apr. 2019, doi:<br>10.1016/j.jcms.2019.01.030. | | 5 | 3.75 -<br>4.0mm | 18-20mm | 15-60° | This retrospective study reported a survival rate of 93.9% and mean bone<br>loss of 1.21mm after 3 years of loading. | M. M. Curi, C. L. Cardoso, and K. D. C. B.<br>Ribeiro, "Retrospective Study of Pterygoid<br>Implants in the Atrophic Posterior Maxilla:<br>Implant and Prosthesis Survival Rates Up<br>to 3 Years," Int J Oral Maxillofac Implants,<br>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 | Reference Device | |-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Standard Length IBR36d Implant<br>Range | K163634 | K212785 | K050406 | | | Southern Implants (Pty) Ltd | External Hex Implants<br>Southern Implants (Pty) Ltd | Blue Sky Bio Implant System<br>Blue Sky Bio, LLC | NOBELSPEEDY Implants<br>Nobel Biocare USA, LLC | | Indications for Use<br>Statement | Southern Implants' External Hex Implants<br>are intended for surgical placement in the<br>upper or lower jaw to provide a means for<br>prosthetic attachment of crowns, bridges or<br>overdentures utilizing delayed or immediate<br>loading. Southern Implants' External Hex<br>Implants are intended for immediate<br>function when good primary stability with<br>appropriate occlusal loading is achieved.<br><br>When using Southern Implants' Standard<br>Length IBR36D Implants with angulation of<br>36° a minimum of 4 implants must be used<br>and splinted.<br><br>The angled Co-Axis External Hex Implants<br>are intended to be used with straight<br>multiple-unit abutments (Compact Conical<br>abutments) only with no additional<br>angulation allowable on the restoration. | Southern Implants' External Hex Implants<br>are intended for surgical placement in the<br>upper or lower jaw to provide a means for<br>prosthetic attachment of crowns, bridges or<br>overdentures utilizing delayed or immediate<br>loading. Southern Implants' External Hex<br>Implants are intended for immediate<br>function when good primary stability with<br>appropriate occlusal loading is achieved. | Blue Sky Bio Multi One Implant System is<br>intended for surgical placement in the bone<br>of the upper or lower jaw to provide support<br>for prosthetic devices to restore chewing<br>function. Implants may be used with single-<br>stage or two-stage procedures. They can be<br>loaded immediately when good primary<br>stability is achieved and with appropriate<br>occlusal loading.<br><br>Blue Sky Bio Multi One Implant System<br>with a 45° angulation are indicated for<br>surgical installation in the pterygoid region<br>only, in cases of severe jaw resorption, in<br>order to restore patient esthetics and<br>chewing function. | NobelSpeedy<br>implants are root-form<br>endosseous implants intended to be<br>surgically placed in the bone of the upper or<br>lower jaw arches to provide support for<br>prosthetic devices, such as an artificial<br>tooth, in order to restore patient esthetics<br>and chewing function. Nobel Biocare's<br>NobelSpeedy implants are indicated for<br>single or multiple unit restorations in<br>splinted or non-splinted applications.<br>NobelSpeedy implants may be placed<br>immediately and put into immediate<br>function providing that initial stability<br>requirements detailed in the surgical manual<br>are satisfied.<br><br>NobelSpeedy implants are indicated for use<br>in soft bone or whenever immediate or early<br>loading is applied. The NobelSpeedy<br>implants incorporate a groove on the<br>implant thread and are11refered over<br>models without the groove in these soft<br>bone indications because bone forms more<br>rapidly in the groove than on other parts of<br>the implant resulting in increased stability<br>when compared to non-groove implants. In<br>addition, the NobelSpeedy implants are<br>preferred in these soft bone indications<br>because bone formation on the TiUnite®<br>surface is more rapid and greater than on<br>machined surface implants resulting in<br>better maintenance of initial implant<br>stability, faster and stronger<br>osseointegration, and higher success rates.<br><br>NobelSpeedy implants may be tilted up to<br>45°. When used with angulations between<br>30° and 45° a minimum of 4 implants must<br>be used and splinted. | | Product Code | DZE | DZE | DZE | DZE | | Intended Use | Functional and esthetic rehabilitation of the<br>edentulous mandible and maxilla. | Functional and esthetic rehabilitation of the<br>edentulous mandible and maxilla. | Functional and esthetic rehabilitation of the<br>edentulous mandible and maxilla. | Functional and esthetic rehabilitation of the<br>edentulous mandible and maxilla. | | Reason for<br>Predicate/Reference | Not applicable | Implant Length<br>Implant Design<br>External Connection and Prosthetic<br>Diameter<br>Machined Collar<br>Material and Surface<br>Sterility and Usage | Implant Design<br>Implant Diameter<br>Platform Angle | Implant Angulation<br>Indications for use restriction of 4 implants<br>to be used and splinted. | | Item Code | IBR36d | IBR24d; MSC-IBR24d | Not provided | Not provided…
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