TIB Abutment System

K193084 · Southern Implants (Pty), Ltd. · NHA · Oct 27, 2020 · Dental

Device Facts

• Record ID: K193084
• Device Name: TIB Abutment System
• Applicant: Southern Implants (Pty), Ltd.
• Product Code: NHA · Dental
• Decision Date: Oct 27, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

TIB Abutment System comprises premanufactured titanium alloy (ASTM F136) base and custom-milled zirconia mesostructure; used for prosthetic rehabilitation on endosseous dental implants. Workflow: desktop scanner captures patient anatomy; 3Shape Abutment Designer software designs custom restoration; WorkNC CAM software and Roland DWX51D milling machine fabricate zirconia mesostructure. Abutment base interfaces between implant and restoration. Operated by dental laboratory technicians; output is a patient-specific dental prosthesis. Benefits include restoration of chewing function. System integrates digital dentistry components; validated via ISO 14801 fatigue testing and biocompatibility standards.

Clinical Evidence

No clinical data included. Evidence consists of bench testing: biocompatibility (ISO 10993-1, ISO 10993-5), sterilization validation (ISO 17665-2), software validation (FDA Off-The-Shelf Software Guidance), scanning/milling validation, and static/dynamic compression-bending testing (ISO 14801).

Technological Characteristics

Two-piece abutment: Titanium Grade 5 alloy (ASTM F136) base, zirconia mesostructure. Machined and gold-anodized surface. Compatible with Southern Implants platforms (External Hex, Deep Conical, Provata, Tri-Nex). CAD/CAM workflow using 3Shape E3 scanner, 3Shape Abutment Designer, WorkNC CAM, and Roland DWX51D mill. Non-sterile. Software validation per FDA guidance.

Indications for Use

Indicated for prosthetic rehabilitation in patients requiring dental restoration via endosseous dental implants. Used to support custom-designed zirconia mesostructure restorations for chewing function.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

• Universal Base Abutment (K180899)

Reference Devices

• InterActive SMARTBase Abutments (K181359)
• Sirona Dental CAD/CAM System (K111421)
• External Hex Implants (K163634)
• Zirconia restorative material, SageMaxx NexxZr (K130991)
• Multilink Hybrid Abutment Cement (K130436)
• 3Shape Abutment Designer Software (K151455)

Submission Summary (Full Text)

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October 27, 2020

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

Re: K193084

Trade/Device Name: TIB Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: October 19, 2020 Received: October 20, 2020

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 (OS) 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) K193084

Device Name TIB Abutment System

#### Indications for Use (Describe)

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

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

| <span style="font-size:10px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
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| <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary

## K193084

## TIB Abutment System

## Southern Implants (Pty) Ltd

October 27, 2020

#### ADMINISTRATIVE INFORMATION

Manufacturer Name

Official Contact

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

Lauranda G. Breytenbach Head of Regulatory Affairs and Quality Email: lauranda.b(@southernimplants.com

#### DEVICE NAME AND CLASSIFICATION

Trade/Proprietary name Common name

Classification name Classification regulation Product Code

Classification Panel Reviewing Branch

TIB Abutment System Dental Abutment

Endosseous Dental Implant Abutment 21 CFR 872.3630, Class II NHA, PNP

Dental Products Panel Dental Devices Branch

### PREDICATE DEVICE INFORMATION

The primary predicate device is K180899 The reference predicate devices are K181359, K111421, K163634, K130991, K130436 and K151455

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## INDICATIONS FOR USE STATEMENT

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

### SUBJECT DEVICE DESCRIPTION

This submission includes two major components which make up the TIB Abutment Base and the mesostructure restoration.

The TIB Abutment base is a standard premanufactured titanium alloy abutment for supporting a dental restoration and mesostructure. The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The TIB abutment base then serves as the interface between the endosseous implant and the zirconia restoration. The TIB Abutment Base is designed to support the restoration on an endosseous implant in order to restore chewing function for the patient.

The mesostructured restoration is a CAD/CAM designed prosthesis milled out of zirconia, which is designed to fit the abutment base in order to restore chewing for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case by case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration.

The TIB Abutments are compatible with the Southern Implants' Deep Conical, External Hex, Provata and Tri-Nex implants and screws. The TIB abutment bases are manufactured from Titanium alloy conforming to ASTM F136 and are color coded by gold anodizing. The anodization process is the same as used for previously cleared anodized titanium alloy devices in K163634. The Mesostructure restoration is to be manufactured from Zirconia - Sage Max NexxZr which has been previously cleared for use in K 130991.

The digital workflow includes the following products (not subject devices to this submission):

- Ceramic material: Sage Max NexxZr Zirconia Restorative material (K130991) ●
- Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436) ●
- Desktop scanner: 3Shape E3 Desktop Scanner is 510(k) exempt under regulation . 872.3661)
- . Abutment design software: 3Shape Abutment Designer Software (K151455)
- Milling machine: Roland DWX51D Milling Machine ●

### PERFORMANCE DATA

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments; Biocompatibility testing per the FDA Guidance Document for Use of Standard ISO 10993-1. "Biological evaluation of medical devices - Partl: Evaluation and testing within a risk management process" and ISO 10993-5 "Biological Evaluation of Medical Devices – Part 5: Tests for In

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Vitro Cytotoxicity": validated sterilization instructions per ISO 17665-2; software validation testing per the FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices; scanning and milling validation; and static and dynamic compression-bending to ISO 14801. No clinical data was 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 device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

K180899, Universal Base Abutment, Nobel Biocare K111421, Sirona Dental CAD/CAM System, Dentsply Sirona K181359, InterActive SMARTBase Abutments, Implant Direct K163634, External Hex Implants, Southern Implants K130991, Zirconia restorative material, SageMaxx NexxZr K130436, Multilink Hybrid Abutment Cement, Ivoclar Vivadent K151455, 3Shape Abutment Designer Software, 3Shape A/S

The primary predicate is K180899.

The reference predicate devices are K181359, K111421, K163634, K130991, K130436 and K151455.

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

| | Subject Abutment | Primary Predicate | Reference Predicates | | | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Southern<br>Implants<br>TIB<br>Abutment | Universal Base<br>Abutment<br>(K180899) | InterActive<br>SMARTBase<br>Abutments (K181359) | Sirona<br>CAD/CAM<br>(K111421) | Dental<br>System | Southern<br>Implants<br>External<br>(K163634) |
| Abutment Design | 2 Piece -<br>Premanufactured<br>titanium abutment,<br>mounted onto the<br>implant and fixed<br>with a screw.<br>SageMaxx Zirconia<br>(K130991)<br>hybrid/crown<br>restoration milled<br>and bonded to the<br>titanium abutment. | 2 Piece - Enamic<br>(K153645) bonded to<br>Universal Base<br>Abutment mounted<br>onto the implant and<br>fixed with a screw | Abutment body consisting<br>of a titanium base and<br>supplied with a fixation<br>screw. The bases are<br>provided with straight,<br>angled, and modified<br>zirconia tops for patient<br>specific devices. The<br>devices are also provided<br>without a zirconia top and<br>a superstructure or hybrid<br>crown or bridge can be<br>milled to fit the bases<br>intended to be<br>manufactured at Implant<br>Direct Manufacturing<br>facility's | The TiBase is a<br>premanufactured<br>prosthetic component<br>directly connected to<br>endosseous dental<br>implants with a screw<br>and is intended for use<br>as an aid in prosthetic<br>rehabilitation. | | Sterile: Cover Screw,<br>Healing Caps,<br>Abutments,<br>Titanium Abutments,<br>Anatomic<br>Abutments, Cosmetic<br>Abutments,<br>Compact Abutments<br><br>Non-sterile:<br>Abutments,<br>Chrome Abutments,<br>Passive Abutments |
| Maximum<br>Abutment<br>Angulation | 20° | 20° | 30° | 20° | - | - |
| Restoration<br>Material | Zirconia - Sage<br>Maxx NexxZr<br>(K130991) | Enamic (K153645) | Zenostar MT | Cercon HT | - | |
| Post Height | Minimum 4.5mm | Minimum 5.2mm | Single Unit - Minimum 4 mm<br>Multi-Unit -<br>Minimum 4 mm | Minimum 4mm | - | |
| | Subject Abutment | Primary Predicate | Reference Predicates | | | |
| Characteristics | Southern<br>Implants<br>TIB<br>Abutment | Universal<br>Base<br>Abutment<br>(K180899) | Inter Active<br>SMARTBase<br>Abutments (K181359) | Sirona<br>Dental<br>CAD/CAM<br>System<br>(K111421) | Southern<br>Implants<br>External<br>Hex<br>(K163634) | |
| Screw Thread | 1-72 unf-2b, M1.6,<br>M1.8 and M2 | Not available | M1.6, M2 | M1.6,<br>M2<br>(NobelActive) | M2 | |
| Compatible<br>Implant Platforms | Southern Implants:<br>External<br>Hex<br>Implants<br>Provata Implants<br>Deep Conical<br>Implants<br>Tri-Nex Implants | Nobel Biocare<br>External Hex<br>Narrow Platform<br>(NP)<br>Regular Platform<br>(RP)<br>Wide Platform (WP) | InterActive SMARTBase<br>abutments are compatible<br>at the implant level with<br>InterActive (3.0mm and<br>3.4mm Platform) and<br>SwishActive (3.0mm and<br>3.4mm Platform) system<br>implants. | The InCoris<br>mesostructure and<br>TiBase two-piece<br>abutment is compatible<br>with the following<br>implant systems: Nobel<br>Biocare Replace<br>(K020646), Nobel<br>Biocare Branemark<br>(K022562), Friadent<br>Xive (K013867),<br>Biomet 3i Osseotite<br>(K980549), Astra Tech<br>Osseospeed<br>(K091239), Zimmer<br>Tapered Screw-Vent<br>(K061410), Straumann<br>Synocta (K061176),<br>Straumann Bone Level<br>(K053088), Biomet 3i<br>Certain (K014235),<br>Nobel Biocare Active<br>(K071370). | Southern<br>Implants<br>External Hex Implants | |
| CAD/CAM Design<br>Workflow | 3Shape E3 Desktop<br>Scanner (3Shape<br>A/S). 3Shape<br>Abutment Designer<br>Software (Shape<br>A/S)- K151455 | 3Shape Intra oral<br>scanner Trios<br>(3Shape A/S). 3Shape<br>Abutment Designer<br>Software (Shape<br>A/S)- K151455 | 3M Tru-Definition, ITero<br>Scanner 3Shape<br>Abutment Designer<br>Software (3Shape A/S) -<br>K151455 | Sirona software – inlab<br>15.0 and above Sirona<br>software - CEREC 4.4<br>and above | | |
| CAD/CAM<br>Manufacturing<br>Workflow | WorkNC CAM<br>software, Roland<br>DWX51D milling<br>unit | CORITEC milling<br>unit (imes-icore) | Wieland-Zenotec Select<br>& Zenotec CAM | CEREC MCXL<br>product family | | |
| Mechanical Testing | Dynamic Fatigue<br>Testing per ISO<br>14801 | Dynamic Fatigue<br>Testing per ISO<br>14801 | Dynamic Fatigue Testing<br>per ISO 14801 | Dynamic Fatigue<br>Testing per ISO 14801 | Dynamic Fatigue<br>Testing per ISO 14801 | |
| Titanium<br>Abutment Material | Titanium Grade 5<br>Alloy (ASTM<br>F136) | Titanium Vanadium<br>Alloy (ASTM F136) | Titanium | TiBase - Titanium<br>6AL4V | Titanium Grade 5<br>Alloy (ASTM F136) | |
| Abutment Surface<br>Treatment | Machined and<br>Anodized gold | | Abutments are titanium<br>anodized gold and pink<br>(grooves are machined for<br>cement adhesion). | Cemented surfaces are<br>blasted with aluminum<br>oxide. | Anodized, Grooved | |
| Screw Material | Titanium Grade 5<br>(ASTM F136) | Titanium | Titanium | Titanium | Titanium Grade 5<br>(ASTM F136) | |
| Sterility | Supplied non-<br>sterile | Supplied non-sterile | Supplied non-sterile | Supplied non-sterile | Supplied sterile | |
| Use | Single-Use | | Single-Use | Single-Use | Single-Use | |
| Indications for Use | The TIB<br>Abutments are<br>premanufactured<br>prosthetic<br>components directly<br>connected to<br>endosseous dental<br>implants and are<br>intended for use as<br>an aid in<br>prosthetic<br>rehabilitation. The<br>TIB abutments | The Universal Base<br>Abutments are<br>premanufactured<br>prosthetic<br>components directly<br>connected to<br>endosseous dental<br>implants and are<br>intended for use as<br>an aid in prosthetic<br>rehabilitation. The<br>Universal Base | InterActive/SwishActive<br>Implant System consists<br>of two-piece implants for<br>one-stage or two-stage<br>surgical procedures.<br>These implants are<br>intended for use in<br>partially and fully<br>edentulous upper and<br>lower jaws in support of<br>single or multiple unit<br>restorations and terminal | The Sirona Dental<br>CAD/CAM System is<br>intended for use in<br>partially or fully<br>edentulous mandibles<br>and maxillae in support<br>of single or multiple<br>unit cement retained<br>restorations. The<br>system consists of<br>three major parts:<br>TiBase, InCoris | Southern Implants'<br>External Hex Implants<br>are intended for<br>surgical placement in<br>the upper or lower<br>jaw to provide a means<br>for prosthetic<br>attachment of crowns,<br>bridges or overdentures<br>utilizing delayed or<br>immediate loading. | |
| Characteristics | Subject Abutment | Primary Predicate | Reference Predicates | | | |
| | Southern<br>Implants<br>TIB<br>Abutment | Universal<br>Base<br>Abutment<br>(K180899) | InterActive<br>SMARTBase<br>Abutments (K181359) | Sirona<br>Dental<br>CAD/CAM<br>System<br>(K111421) | Southern<br>Implants'<br>External<br>Hex<br>(K163634) | |
| | consists of two<br>major parts.<br>Specifically, the<br>titanium base and<br>mesostructure<br>components make<br>up a two-piece<br>abutment.<br>The system<br>integrates<br>multiple<br>components of the<br>digital dentistry<br>workflow: Scan<br>files from desktop<br>scanners, CAD<br>software, CAM<br>software, ceramic<br>material, milling<br>machine and<br>associated tooling<br>and accessories. | two major parts.<br>Specifically, the<br>titanium base and<br>mesostructure<br>components make up<br>a two-piece abutment.<br>The system integrates<br>multiple components<br>of the digital dentistry<br>workflow: scan files<br>from Intra-Oral<br>Scanners, CAD<br>software, CAM<br>software, ceramic<br>material, milling<br>machine and<br>associated tooling and<br>accessories. | SMARTBase abutment<br>support for fixed<br>bridgework. The system<br>integrates multiple<br>components of the digital<br>dentistry workflow: scan<br>files from Intra-Oral<br>Scanners, CAD software,<br>CAM software, ceramic<br>material, milling machine<br>and associated tooling and<br>accessories.<br>The<br>SMARTBase Abutments<br>consist of two major parts.<br>Specifically, the titanium<br>base and zirconia top<br>components make up a<br>two-piece abutment.<br>Implants can be indicated<br>for immediate loading<br>when good primary<br>stability has been<br>achieved and with<br>appropriate occlusal<br>loading. Narrow Diameter<br>(3.2, 3.3mm) Implants:<br>Indicated for single-tooth<br>replacement of<br>mandibular central and<br>lateral incisors and<br>maxillary lateral incisors.<br>Also indicated for<br>multiple tooth<br>replacements or denture<br>stabilization. | CAD/CAM software.<br>Specifically, the<br>InCoris mesostructure<br>and TiBase<br>components make up a<br>two-piece abutment<br>which is used in<br>conjunction with<br>endosseous dental<br>implants to restore the<br>function and aesthetics<br>in the oral cavity. The<br>InCoris mesostructure<br>may also be used in<br>conjunction with the<br>Camlog Titanium base<br>CAD/CAM (types<br>K2244.xxxx)<br>(K083496) in the<br>Camlog Implant<br>System.<br>The<br>CAD/CAM software is<br>intended to design and<br>fabricate the InCoris<br>mesostructure. | Southern Implants'<br>External Hex Implants<br>are intended for<br>immediate function<br>when good<br>primary stability with<br>appropriate occlusal<br>loading is achieved. | |

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The Indications for Use Statement for the subject device is the same as that of the primary predicate device

K K 000 States 1.10 de same the comments of the shier der abies der abies deriver anders anderse anderse armer
The subject devier Listes in the market ber antier der seteller

The primary predicate and the subject device have the identical maximum angulation for t restoration and follow an equivalent design workflow. In the design workflow the primary predicate uses a different scanner but the same software to design the restoration. The design workflow differing with the scanner does not impact demonstrating substantial equivalence. The difference in scanner was shown to not affect substantial equivalence by way of software validation, scanning and milling validation, and static and dynamic compression-bending according to ISO 14801.

The subject device is also substantially equivalent to the primary predicate with reference to the abutment's restoration material with the subject and the primary predicate both making use of a ceramic composite riate performance testing on the ceramic component of the two-piece abutment. The both the subject device and primary predicate is a um Allov (ASTM

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F136), the screw material is Titanium for both the subject and primary predicate. Both the subject and the primary predicate devices are provided non-sterile. Thus, the abutment materials and method provided of the subject device are substantially equivalent to that of the primary predicate. The different manufacturing and ceramic material comparison were addressed with biocompatibility testing per the FDA Guidance Document for Use of Standard ISO 10993-1. "Biological evaluation of medical devices – Partly Evaluation and testing within a risk management process", and validated sterilization instructions per the FDA Guidance Document for Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labelling.

The reference predicate K181359 is for substantial equivalence of the Subject Device screw thread, manufacturing workflow, abutment surface treatment and usage. The subject device makes use of the same screw threads as the reference device (K181359) with a difference of the 1-72 unf-2b (1.85mm) and M1.8 screw threads. The screw threads differing with the addition of intermediary screw threads does not impact demonstrating substantial equivalence, and this was shown with static and dynamic compression-bending according to ISO 14801.

In terms of the manufacturing workflow, the subject device makes use of the WorkNC CAM software and a Roland DWX51D milling unit. The reference device (K181359) Makes use of Zenotec CAM and Wieland-Zenotec Select milling unit. While both are different brands, both devices make use of CAM software, communicating with a milling unit. The manufacturing workflow differing with CAM software and milling unit brands does not impact demonstrating substantial equivalence, and this was shown by of software validation, scanning and milling validation, and dynamic compression-bending according to ISO 14801.

The reference device (K163634) is for substantial equivalence of abutment material, surface treatment and packaging methods. The subject device abutments are manufactured from Titanium alloy conforming to ASTM F136 and are color coded by anodizing. The anodization process is the same as that used for the reference device (K163634). Both the subject and the reference device are packaged with the same methods for single use. Thus, the material, surface treatment and packaging methods of the subject device is considered substantially equivalent to that of the reference device.

The reference predicate K111421 is for substantial equivalence of the compatible implant platforms. The subject device is designed to connect directly to the Southern Implants External Hex, Deep Conical and Tri-Nex connection types. While the reference device (K111421) is designed to connect directly to multiple different implant systems, which together encompass the same range of implant platform types as that of the subject device. This, with the addition of Mechanical ISO 14801 Fatigue Testing of all four implant platforms proves substantial equivalence of the compatible implant platforms.

The post height of the subject device is indicated to a minimum of 4.5mm. The primary predicate (K180899) is indicated to a minimum of 5.2mm, while the reference device (K181359) is indicated to a minimum of 4mm. The subject device post height lies between these two predicate minimums and is thus substantially equivalent.

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. Furthermore, biocompatibility testing per the FDA Guidance Document for Use of Standard ISO 10993-1, "Biological evaluation of medical devices – Part1: Evaluation and tes…