Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Southern Implants (Pty) Ltd Colin Saffy Head of Regulatory Affairs and Ouality 1 Albert Road Irene, Gauteng 0062 SOUTH AFRICA Re: K230873 Trade/Device Name: Angulated Screw Channel (ASC) Solution Abutments and SI-BASE Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA. PNP Dated: June 29, 2023 Received: June 30, 2023 Dear Colin Saffy: 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. {1}------------------------------------------------ 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 mediation-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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K230873 #### Device Name Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments #### Indications for Use (Describe) The Angulated Screw Channel (ASC) Solution Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The ASC Solution Abutments and SI-BASE Abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAD software, ceramic material, milling machine and associated tooling and accessories. The intended use for the engaging ASC Solution Abutments and SI-BASE Abutments used with the Ø3.0 External-Hex implants, Ø3.3 PROVATA implants and Ø3.5/Ø4.0 Deep Conical implants are intended for use with a straight mesostructure component. The intended use for the engaging ASC Solution Abutments and SI-BASE Abutments used with the Ø3.4 and Ø4.0 External-Hex implants. PROVATA implants and 03.5 and 04.3 TRI-NEX implants is limited to replacement of maxillary and mandibular lateral and central incisors. The ASC Solution Abutments and SI-BASE Abutments for Compact Conical Abutments are intended for use on straight Compact Conical Abutments with a straight mesostructure component. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <span> <span style="text-decoration: underline;"></span>Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> | |-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------| |-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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](mailto: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."* Form Approved: OMB No. 0910-0120 PSC Publishing Services (301) 443-6740 {3}------------------------------------------------ # 510(k) Summary K230873 # Angulated Screw Channel (ASC) Solution and SI-BASE Abutments # Southern Implants (Pty) Ltd July 31, 2023 #### 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 | Colin A. Saffy<br>Head of Regulatory Affairs and Quality | #### DEVICE NAME AND CLASSIFICATION Trade/Proprietary name Common name Classification name Classification regulation Primary Product Code Secondary Product Code Classification Panel Reviewing Branch Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments Dental Abutment Endosseous Dental Implant Abutment 21 CFR 872.3630, Class II NHA PNP Email: colin.s(@southernimplants.com Dental Products Panel Dental Devices Branch #### PREDICATE DEVICE INFORMATION The primary predicate device is K193084 The reference predicate devices are K173706, K222457, K163634, K163060, K053478, K070905, K130991, K130436, and K151455. {4}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT The Angulated Screw Channel (ASC) Solution Abutments and SI-BASE Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The ASC Solution Abutments and SI-BASE Abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a multi-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. The intended use for the engaging ASC Solution Abutments and SI-BASE Abutments used with the Ø3.0 External-Hex implants, 03.3 PROVATA implants and 03.5/04.0 Deep Conical implants are intended for use with a straight mesostructure component. The intended use for the engaging ASC Solution Abutments and SI-BASE Abutments used with the 03.4 and Ø4.0 External-Hex implants , PROVATA implants and Ø3.5 and Ø4.3 TRI-NEX implants is limited to replacement of maxillary and mandibular lateral and central incisors. The ASC Solution Abutments and SI-BASE Abutments for Compact Conical Abutments are intended for use on straight Compact Conical Abutments with a straight mesostructure component. #### SUBJECT DEVICE DESCRIPTION This submission includes two major components which make up the ASC Solution and SI-BASE Abutments - The ASC Solution and SI-BASE Abutment Base and the mesostructure restoration. Twopiece and three-piece abutments models are included. Two-piece abutments consist of the ti-base abutment and mesostructure. Three-piece abutments consist of the ti-base abutment, mesostructure, and compatible compact conical abutments. The ASC Solution and SI-BASE Abutments are standard premanufactured titanium alloy abutments for supporting a dental restoration and mesostructure. The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The ASC Solution and SI-BASE Abutments then serve as the interface between the endosseous implant and the zirconia restoration. The abutments are 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 function 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 ASC Solution and SI-BASE Abutments are compatible with the Southern Implants' Deep Conical, External Hex, Provata and Tri-Nex implants and screws. The abutments are manufactured from Titanium alloy conforming to ASTM F136 and are color coded by Titanium nitride coating (ASC Solution Abutments) or yellow anodizing (SI-BASE Abutments). The TiN coating and anodization processes are 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 K130991. 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) . {5}------------------------------------------------ - Intra-oral scanner: 3Shape E3 Desktop Scanner - Abutment design software: 3Shape Abutment Designer Software (K151455) - Milling machine: Roland DWX51D Milling Unit ● ## 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 - Part1: Evaluation and testing within a risk management process" and ISO 10993-5 "Biological Evaluation of Medical Devices - Part 5: Tests for In-Vitro Cytotoxicity"; validated sterilization instructions per ISO 17665-1 and 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 according to ISO 14801. No clinical data was included in this submission. Software verification and validation testing was provided for the subject abutment design library to demonstrate use with both the 3Shape Abutment Designer Software verification and validation testing were conducted to demonstrate that the restrictions prevent design of the top half component of the multi-piece abutment outside of the allowable design limitations, including screenshots under user verification testing. In addition, the encrypted abutment design library was validated to demonstrate that the established design limitations are locked and cannot be modified within the abutment design library. 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" was performed on the previously cleared devices, K222457, PROVATA Implant System. The ASC Solution Abutments and SI-BASE Abutments were compared to the predicate devices. The ASC Solution and SI-BASE abutments 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. ## 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 substantially equivalent in indications and design principles to the following legally marketed predicate devices: K 193084, TIB Abutment System, Southern Implants (Pty) Ltd. K173706, Piccolo Implants and Accessories, Southern Implants (Pty) Ltd. K222457, PROVATA Implant System, Southern Implants (Pty) Ltd. K 163634, External Hex Implants and Accessories, Southern Implants (Pty) Ltd. K163060, Deep Conical (DC) Implants and Accessories, Southern Implants (Pty) Ltd. K053478, Endosseous Dental Implant System, Northern Implants (Pty) Ltd. K070905, Endosseous Dental Implant System, Southern Implants (Pty) Ltd. K130991, Zirconia restorative material, SageMaxx NexxZr K130436, Multilink Hybrid Abutment Cement, Ivoclar Vivadent K151455, 3Shape Abutment Designer Software, 3Shape A/S The primary predicate device is K193084. The reference predicate devices are K053478, K070905, K163060, K163634, K22457 K130991, K130436, and K151455. A comparison of the technological characteristics of the subject device and the predicate devices is provided in the following table: {6}------------------------------------------------ | | Subject Device | Primary Predicate Device | Reference Device | Reference Device | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Comparison | Angulated Screw Channel (ASC)<br>Abutment System and SI-BASE<br>Abutment System<br>Southern Implants (Pty) Ltd<br>(External Hex ASC Abutments) | K193084<br>TIB Abutment System<br>Southern Implants (Pty) Ltd | K173706<br>Piccolo Implants and Accessories<br>Southern Implants (Pty) Ltd | K163634<br>External Hex Implants<br>Southern Implants (Pty) Ltd | | Indications for Use<br>Statement | The Angulated Screw Channel (ASC)<br>Solution Abutments and SI-BASE<br>Abutments are premanufactured<br>prosthetic components directly<br>connected to endosseous dental implants<br>and are intended for use as an aid in<br>prosthetic rehabilitation. The ASC<br>Solution Abutments and SI-BASE<br>Abutments consist of two major parts.<br>Specifically, the titanium base and<br>mesostructure components make up a<br>multi-piece abutment. The system<br>integrates multiple components of the<br>digital dentistry workflow: Scan files<br>from desktop scanners, CAD software,<br>CAM software, ceramic material,<br>milling machine and associated tooling<br>and accessories.<br>The intended use for the engaging ASC<br>Solution Abutments and SI-BASE<br>Abutments used with the Ø3.0 External-<br>Hex implants are intended for use with a<br>straight mesostructure component.<br>The intended use for the engaging ASC<br>Solution Abutments and SI-BASE<br>Abutments used with the Ø3.4 and Ø4.0<br>External-Hex implants is limited to<br>replacement of maxillary and<br>mandibular lateral and central incisors. | The TIB Abutments are premanufactured<br>prosthetic components directly connected<br>to endosseous dental implants and are<br>intended for use as an aid in prosthetic<br>rehabilitation. The TIB abutments consists<br>of two major parts. Specifically, the<br>titanium base and mesostructure<br>components make up a two-piece<br>abutment. The system integrates multiple<br>components of the digital dentistry<br>workflow: Scan files from desktop<br>scanners, CAD software, CAM software,<br>ceramic material, milling machine and<br>associated tooling and accessories. | The Piccolo Implants and Accessories are<br>intended for both one- and two-stage surgical<br>procedures in the following situations and with the<br>following clinical protocols:<br>· replacing maxillary lateral incisors and<br>mandibular incisors,<br>· immediate placement in extraction sites and in<br>situations with a partially or completely healed<br>alveolar ridge,<br>· immediate loading when good primary stability<br>with appropriate occlusal loading is achieved,<br>except in soft bone (type IV) where implant<br>stability may be difficult to obtain. | 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. | | Product Code | NHA, PNP | NHA, PNP | DZE, NHA | DZE, NHA | | Reason for<br>Predicate/Reference | n/a | Abutment (general design and functioning)<br>Software Compatibility<br>Abutment Connection Type and Size | Ø3.0 External Hex Abutment Connection Type<br>and Size<br>Abutment Surface | External Hex Abutment Connection Type<br>and Size<br>Abutment Post Height | | Abutment Types | External Hex Angulated Screw<br>Channels<br>External Hex SI-BASE Abutments | External Hex TiBase Abutments | Piccolo Abutments | Straight titanium abutments:<br>Titanium cylinders<br>Anatomic abutments | | Prothesis Attachment | Cement-retained<br>Screw-retained | Cement-retained<br>Screw-retained | Cement-retained<br>Screw-retained | Cement-retained<br>Screw-retained | | Restoration | Single-unit | Single-unit | Single-unit | Single-unit | | Abutment Connection<br>Interface | Southern Implants External Hex | Southern Implants External Hex | Southern Implants External Hex | Southern Implants External Hex | | Abutment Connection<br>Interface Diameters | Ø3.00 to Ø4.07 | Ø3.43 to Ø4.07 | 03.00 | Ø3.43 to Ø4.07 | | Abutment Restorative<br>Platform Diameter | Ø4.00 to Ø4.60 | Ø4.30 to Ø5.10 | 03.5 | Ø3.40 to Ø4.05 | | Collar/Gingival<br>Height | 1.5mm | 0.6, 1.5 or 3mm | 0.6, 0.75 or 1 mm | 1mm to 5mm | | Abutment Post<br>Height | Minimum 4.5mm | Minimum 4.5mm | Minimum 4mm | n/a | | Abutment Angulation | 0° | 0° | 0° | 0° | | Abutment Material | Titanium Grade 5 Alloy (ASTM F136) | Titanium Grade 5 Alloy (ASTM F136) | Titanium Grade 5 Alloy (ASTM F136) or<br>Titanium Grade 4 (ASTM F67) or Gold Alloy | Titanium Grade 5 Alloy (ASTM F136) or<br>Titanium Grade 4 (ASTM F67) or Gold<br>Alloy | | Abutment Surface | Machined | Machined | Machined | Machined | | | Knurled (grooved)<br>Titanium nitride coated | Knurled (grooved)<br>Anodized | Knurled (grooved)<br>Titanium nitride coated | Knurled (grooved) and smooth<br>Titanium nitride coated | | Restoration Material | Zirconia - Sage Maxx NexxZr<br>(K130991) | Zirconia - Sage Maxx NexxZr (K130991) | n/a…