Southern Implants MAX Implant System

K191054 · Southern Implants (Pty), Ltd. · DZE · Dec 9, 2019 · Dental

Device Facts

• Record ID: K191054
• Device Name: Southern Implants MAX Implant System
• Applicant: Southern Implants (Pty), Ltd.
• Product Code: DZE · Dental
• Decision Date: Dec 9, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Southern Implants MAX implant is intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications. This MAX implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

Device Story

Threaded root-form dental implants; external hex, internal tri-lobe, or internal hex interfaces; diameters 6-9mm; lengths 6-11mm. Used by dental surgeons in clinical settings to replace missing teeth; provide support for fixed/removable prostheses; enable immediate loading. Implants made of unalloyed titanium (ASTM F67); grit-blasted surface; some coronal portions unroughened. Includes various abutments (healing, titanium cylinder, cosmetic, gold cylinder, passive, compact conical) and screws. Surgeon selects implant based on bone availability and stability requirements; implants placed in maxillary/mandibular molar regions. Output is a stable foundation for dental restorations; restores chewing function; improves patient quality of life. Non-clinical testing includes engineering, dimensional, and pull-out analysis; biocompatibility established via predicate comparison.

Clinical Evidence

No clinical data included. Substantial equivalence supported by non-clinical bench testing: biocompatibility (referenced), engineering analysis, dimensional analysis, sterilization validation (ISO 11137, ISO 17665), bacterial endotoxin testing (USP 39-NF34), pull-out tests, and surface area analysis.

Technological Characteristics

Threaded root-form dental implants; unalloyed titanium (ASTM F67) or titanium alloy (ASTM F136); grit-blasted surface; external hex, tri-lobe, or internal hex interfaces. Dimensions: 6-9mm diameter, 6-11mm length. Sterilization: sterile (gamma/moist heat) or moist heat for specific abutments. No software or electronic components.

Indications for Use

Indicated for patients requiring dental implants in the maxillary or mandibular molar region where bone is present, specifically when narrower implants risk failure due to poor primary stability or surgical complications. Supports fixed or removable prostheses (single, partial, or full arch) and allows immediate loading on single or splinted restorations when primary stability and occlusal conditions are met.

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

• Endosseous Dental Implant (K071161)

Reference Devices

• External Hex Implants (K163634)
• Endosseous Dental Implant (K070905)
• Provata Implant System (K180465)

Submission Summary (Full Text)

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December 9, 2019

Southern Implants (Pty) Ltd Lauranda Breytenbach Head of Regulatory Affairs and Quality 1 Albert Road Irene, Gauteng 0062 SOUTH AFRICA

Re: K191054

Trade/Device Name: Southern Implants MAX Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 6, 2019 Received: September 10, 2019

Dear Lauranda Breytenbach:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located 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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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K191054

Device Name Southern Implants MAX Implant System

#### Indications for Use (Describe)

Southern Implants MAX implant is intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications. This MAX implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses or full arch prostheses. It further adds the option for immediate loading on single unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| <div> <span> <b> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <b> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 510(k) Summary Southern Implants MAX Implant System Southern Implants (Pty) Ltd December 9, 2019

## K191054

#### ADMINISTRATIVE INFORMATION Manufacturer Name

Southern Implants (Pty) Ltd 1 Albert Road Irene, Gauteng, 0062 South Africa [phone] Telephone Fax [phone]

Official Contact

Lauranda G. Breytenbach Head of Regulatory Affairs and Quality Email: [e-mail]

#### DEVICE NAME AND CLASSIFICATION Trade/Proprietary name Common name

Classification name Classification regulation Product Code

Classification Panel Reviewing Branch

Southern Implants MAX Implant System Dental Implant

Endosseous dental implant 21 CFR 872.3640, Class II DZE, NHA

Dental Products Panel Dental Devices Branch

PREDICATE DEVICE INFORMATION The primary predicate device is K071161 The reference devices are K163634, K070905 and K180465

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## INDICATIONS FOR USE STATEMENT

Southern Implants MAX implant is intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications. This MAX implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

## SUBJECT DEVICE DESCRIPTION

This submission includes threaded root-form dental implants with an external hex and internal tri-lobe interface and mating abutments. The implants are provided in diameters of 6, 7, 8 and 9mm and lengths of 6, 7, 9 and 11mm. Specifically:

- MAX Implants with External Hex Connection .
- o Ø6 mm at lengths of 6, 7, 9, 11 mm
- o Ø7 mm at lengths of 7, 9, 11 mm
- Ø8 mm at lengths of 7, 9, 11 mm O
- Ø9 mm at lengths of 7, 9, 11 mm O
- TRIMAX Implants with Tri-lobe Connection
- Ø7 mm at lengths of 7, 9, 11 mm o
- Ø8 mm at lengths of 7, 9, 11 mm O
- Ø9 mm at lengths of 7, 9, 11 mm O
- PROMAX Implants with Internal Hex Connection ●
- Ø6 mm at lengths of 7, 9, 11 mm O
- Ø7 mm at lengths of 7, 9, 11 mm O
- Ø8 mm at lengths of 7, 9, 11 mm O
- Ø9 mm at lengths of 7, 9, 11 mm O

This submission also includes: Coverscrews in two diameters and implant connection interfaces: Healing Abutments in two implant connection interfaces (tri-lobe and internal hex) with lengths between 3 and 6mm and diameters between 6 and 7.8mm; Titanium Cylinder abutments for temporary restorations in two implant connection interfaces (tri-lobe and internal hex) in engaging and non-engaging configurations; Cosmetic Abutments for permanent restorations in two engaging implant connection interfaces (tri-lobe and internal hex); Gold Cylinder Abutments for permanent restorations in three implant connection interfaces (external hex, tri-lobe and internal hex) in engaging and non-engaging configurations; Passive Abutments for permanent restorations in two implant connection interfaces (trilobe and internal hex) in engaging and non-engaging configurations; Compact Conical abutments in an internal hex connection for multi-unit restorations; and abutment screws. The Gold Cylinder Abutments and Passive Abutments are UCLA castable abutments which interface with a plastic, burn-out sleeve used to fabricate a prosthesis that is bonded directly to the top of the abutment.

All MAX implants are manufactured from unalloyed titanium conforming to ASTM F67. The implant surface is grit blasted with varying lengths of unroughened coronal portions. The Cover Screw, Healing Abutment, Titanium Cylinder Abutment, Cosmetic Abutment and Passive Abutment are manufactured from unalloyed titanium conforming to ASTM F67. The Gold Cylinder Abutment is manufactured from a gold alloy. The Compact Conical Abutments manufactured from titanium alloy conforming to ASTM

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F136. The abutment screws are manufactured from titanium alloy conforming to ASTM F136, or goldplatinum alloy. All subject device components are manufactured in the same facilities using the same materials and manufacturing processes as used for the Southern Implants devices previously cleared in K071161, K163634, K070905 and K180465.

### PERFORMANCE DATA

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility (referenced from K071161 and K180465); engineering analysis; dimensional analysis; sterilization validation according to ISO 11137-1, ISO 11137-2, ISO 17665-1, ISO TS 17665-2; bacterial endotoxin according to USP 39-NF34; sterile barrier shelf life (referenced from K071161). Pull out tests and surface area analysis comparing the worst-case subject device to the predicate device were performed. No clinical data were included in this submission.

## EQUIVALENCE TO MARKETED DEVICE

Southern Implants (Pty) Ltd submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed devices: K071161, Endosseous Dental Implant, Southern Implants (Pty) Ltd

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

K070905, Endosseous Dental Implant, Southern Implants (Pty) Ltd

K180465, Provata Implant System, Southern Implants (Pty) Ltd

The primary predicate device is K071161.

The reference devices are K163634, K070905 and K180465

A comparison of the technological characteristics of the subject device and the primary predicate device K071161 is provided in the following table.

| Comparison | Subject device | Primary Predicate device |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use statement | Southern Implants MAX implant is<br>intended for implantation in the<br>maxillary or mandibular molar<br>region where bone exists and the<br>surgeon has determined that the<br>placement of a narrower diameter<br>implant would increase the<br>probability of failure due to poor<br>primary stability, or increased<br>surgical procedures leading to<br>complications. This MAX implant<br>provides support for fixed or<br>removable dental prostheses in a<br>single tooth, partially edentulous<br>prostheses or full arch prostheses.<br>It further adds the option for<br>immediate loading on single and<br>splinted multiple unit restorations | K071161, Endosseous Dental<br>Implant, Southern Implants (Pty)<br>Ltd<br>NSI MAX implant is intended for<br>implantation in the maxillary or<br>mandibular molar region where<br>bone exists and the surgeon has<br>determined that the placement of a<br>narrower diameter implant would<br>increase the probability of failure<br>due to poor primary stability, or<br>increased surgical procedures<br>leading to complications. This<br>MAX implant provides support for<br>fixed or removable dental<br>prostheses in a single tooth,<br>partially edentulous prostheses or<br>full arch prostheses. It further adds<br>the option for immediate loading on<br>single and splinted multiple unit<br>restorations when good primary |
| | when good primary stability is<br>achieved and with appropriate<br>occlusal loading, to restore chewing<br>function. | stability is achieved and with<br>appropriate occlusal loading, to<br>restore chewing function. |
| Implant Design | | |
| Implant Diameter | 6, 7, 8, 9mm | 8, 9mm |
| Implant Length | 6, 7, 9, 11mm | 7, 9, 11, 13mm |
| Implant Platform Diameter | Ø4.5, 5.5, 5.7, 6.5, 7.5mm | Ø6.5, 7.5mm |
| Implant Prosthetic Diameter | Ø3.575, 4, 5, 5.575, 6, 7mm | Ø6, 7mm |
| Implant Interface | External hex<br>Tri-lobe<br>Internal Hex | External hex |
| Material | Unalloyed titanium (ASTM F67) | Unalloyed titanium (ASTM F67) |
| Implant endosseous surface | Grit-blasted | Grit-blasted |
| Cover Screw | | |
| Platform diameter | Ø5.575, 6mm | Ø7mm |
| Maximum diameter | Ø5.6, 6mm | Ø7mm |
| Material | Unalloyed titanium (ASTM F67),<br>anodized | Unalloyed titanium (ASTM F67) |
| Healing Abutment | | |
| Collar height | 3, 5, 6mm | 4, 5.5, 7mm |
| Collar diameter | 6, 7, 7.8mm | 8mm |
| Material | Unalloyed titanium (ASTM F67),<br>anodized | Unalloyed titanium (ASTM F67) |
| Titanium Cylinder Abutment | | |
| Connection configurations | Engaging (single-unit) and Non-<br>engaging (Multi-unit) | Engaging (single-unit) and Non-<br>engaging (Multi-unit) |
| Prosthesis Attachment | Cement-retained | Cement-retained |
| Collar height | 1, 3mm | 1mm |
| Collar diameter | 6.33, 6.55mm | 7.33mm |
| Abutment Angle | 0° | 0° |
| Abutment Material | Unalloyed titanium (ASTM F67),<br>anodized | Unalloyed titanium (ASTM F67) |
| Abutment Screw Material | Titanium Alloy (ASTM F136) or<br>Gold Alloy | Titanium Alloy (ASTM F136) or<br>Gold Alloy |
| Cosmetic Abutment | | |
| Connection configurations | Engaging | N/A |
| Prosthesis Attachment | Cement-retained | N/A |
| Collar height | Varying from 1.6mm to 2.9mm | N/A |
| Collar diameter | Varying from 6.86 mm to 7.92mm | N/A |
| Abutment Angle | 0° | N/A |
| Abutment Material | Unalloyed titanium (ASTM F67),<br>anodized | N/A |
| Abutment Screw Material | Titanium Alloy (ASTM F136) or<br>Gold Alloy | N/A |
| Gold Cylinder Abutment | | |
| Connection configurations | Engaging (single-unit) and Non-<br>engaging (Multi-unit) | N/A |
| Prosthesis Attachment | Screw-retained | N/A |
| Collar height | 0.5, 0.56, 0.64mm | N/A |
| Collar diameter | 4.3, 6.15, 6.45, 7.15mm | N/A |
| Abutment Angle | 0° | N/A |
| Abutment Material | Gold Alloy | N/A |
| Abutment Screw Material | | N/A |
| | Titanium Alloy (ASTM F136) or<br>Gold Alloy | |
| Passive Abutment | | |
| Connection configurations | Engaging (single-unit) and Non-<br>engaging (Multi-unit) | Engaging (single-unit) and Non-<br>engaging (Multi-unit) |
| Prosthesis Attachment | Screw-retained | Screw-retained |
| Collar height | 0.3, 0.4mm…