(112 days)
No
The document describes a dental implant system and its components, including abutments and the use of CAD/CAM software for designing restorations. While it mentions digital workflows and software for design, there is no mention of AI or ML being used for analysis, decision-making, or any other function within the device or its associated processes. The software mentioned is for design and ensuring limitations are met, not for learning or adaptive tasks.
Yes
The device is described as a "dental implant system" intended for "surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures," which is a therapeutic function for restoring chewing function and aiding in prosthetic rehabilitation.
No
Explanation: The device is an implant system and associated prosthetic components (implants, abutments, screws) intended for surgical placement and prosthetic attachment, not for diagnosing conditions.
No
The device description clearly details physical components such as dental implants, abutments, and screws made from titanium and titanium alloy. While software is mentioned for design purposes (3Shape Abutment Designer Software), the core medical device is hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being surgically placed in the jaw to support prosthetic attachments (crowns, bridges, overdentures). This is a direct therapeutic and restorative function within the body.
- Device Description: The description details dental implants, abutments, screws, and related components used for dental prosthetics. These are all physical devices used in a surgical and restorative context.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided text does not mention any testing of biological samples or diagnostic purposes.
The device described is a dental implant system, which falls under the category of medical devices used for surgical and prosthetic purposes, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
For the implants:
The Single Platform SP1 Implant System is 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. The Single Platform SP1 Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved.
The Single Platform SP1 implants in lengths 20, 22 and 24 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
For the conventional abutment and screws:
The Conventional Abutments and Prosthetic Screws are premanufactured prosthetic components directly connected to endosseous dental implants and intended for use in fully edentulous maxilla and/or maxilla and/or mandible to provide support for crowns, bridges or overdentures.
For the Titanium Abutment Bases and Passive Abutments:
The TIB and Passive Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB and Passive 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.
For the Temporary Titanium Cylinders:
The Southern Implants Temporary Titanium Abutments are prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA, PNP
Device Description
This submission includes fully threaded root-form dental implants with an internal cone and hexagon interface and mating abutments. The implants are provided in three diameters: Ø3.5, Ø4.0 and Ø5.0 mm. The implants are provided in a straight (0° angled) configuration only, with a 3.0 mm extended machined coronal section. The implants are provided in one prosthetic diameter (2.95 mm implants are provided in overall leneths of 8, 10, 11.5, 13, 16, 18 and 20 mm. The Ø4.0 mm implants are provided in overall lengths of 8, 10, 11.5, 13, 16, 18, 20, 22 and 24 mm. The Ø5.0 mm implants are provided in overall lengths of 8, 10, 11.5, 13, 16, and 18 mm.
This submission also includes: a Cover Screw, Healing Abutments in four diameters and multiple gingival heights, Titanium Cylinder Abutments for temporary restorations, Passive Abutments with a plastic burn-out component, Equator Overdenture Abutments in multiple gingival heights, Compact Conical Abutments in straight (0) and angled (17° and 30°) designs, TIB Abutment Bases, and abutment screws.
The Passive Abutments may be restored using either traditional cast-on workflows or digital CAD/CAM workflows using milled zirconia restorations (similar use to the TIB Abutment Bases).
Using the traditional cast-on workflow, the Passive Abutments function as 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, limited to a straight (0°) restoration when utilizing precious metal cast-on restorations.
Using digital CAD/CAM workflows, the TIB Abutment Bases and Passive Abutments function as two-piece abutment designs, consisting of standard premanufactured titanium alloy abutments for supporting the second half (or top-half) of the abutment, a hybrid/crown dental restoration and mesostructure (SageMaxx Zirconia) bonded with cement (Ivoclar Vivadent Multilink Hybrid cement). The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The TIB Abutment Bases and Passive Abutments then serves as the interface between the endosseous implant and the Zirconia restoration. The TIB Abutment Bases and Passive 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 (SageMaxx 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 and a maximum allowable angulation of 20° for the mesostructured component.
All Single Platform SP1 implants are manufactured from unalloyed titanium conforming to ASTM F67, with a smooth machined collar (extended machined surface of 3 mm). The remainder of the entire endosseous threaded surface) is grit-blasted. The subject device implant material and surface is identical to the implants cleared in K222457 and K163060. The Cover Screw and Healing Abutments are manufactured from unalloyed titanium conforming to ASTM F67. The remaining Abutments are manufactured from titanium alloy conforming to ASTM F136. The abutment screws are manufactured from titanium alloy conforming to ASTM F136. 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 K222457 and K163060.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence.
Non-clinical data submitted to demonstrate substantial equivalence includes: engineering analysis; dimensional analysis; sterilization validation according to ISO 11137-1, ISO 17665-1, ISO 17665-1, ISO 17665-2; bacterial endotoxin according to USP 39-NF 34; static and dynamic compression-bending according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants; scanning and milling validation for the Passive Abutments; and 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".
Non-clinical data referenced, or relied upon to demonstrate substantial equivalence includes: biocompatibility evaluations according to ISO 10993-1 (referenced from K222457 and K163060); sterile barrier shelf life (referenced from K222457); validated steam sterilization instructions per ISO 17665-2 (applicable to the Passive Abutments and Titanium Abutment Bases (TIB) which are provided non-sterile and intended for end-user sterilization - referenced from K193084); software validation testing as per the FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices (referenced from K193084); and scanning and milling validation for the Titanium Abutment Bases (TIB) (referenced from K193084).
No clinical data were included in this submission.
Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the 3Shape Abutment Designer Software (only applicable to the TIB Abutment Bases and Passive Abutments when using the digital CAD/CAM workflows for milled zirconia restoration design). Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the top half component of the two-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 and specifications 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'' (ASTM F2503, ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119) was performed on the previously cleared devices, K222457, PROVATA Implant System. The subject devices were compared to the predicate devices. The subject 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K190958, K163060, K222457, K180536, K191191, K212785, K130991, K130436
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Southern Implants (Pty) Ltd Michelle dos Santos Senior Design Engineer 1 Albert Road Irene, Gauteng 0062 SOUTH AFRICA
Re: K232418
Trade/Device Name: Single Platform SP1 Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE. NHA. PNP Dated: November 1, 2023 Received: November 2, 2023
Dear Michelle dos Santos:
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
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 Quality Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K232418
Device Name Single Platform SP1 Implant System
Indications for Use (Describe)
For the implants:
The Single Platform SP1 Implant System is 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. The Single Platform SP1 Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved.
The Single Platform SP1 implants in lengths 20, 22 and 24 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
For the conventional abutment and screws:
The Conventional Abutments and Prosthetic Screws are premanufactured prosthetic components directly connected to endosseous dental implants and intended for use in fully edentulous maxilla and/or maxilla and/or mandible to provide support for crowns, bridges or overdentures.
For the Titanium Abutment Bases and Passive Abutments:
The TIB and Passive Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB and Passive 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.
For the Temporary Titanium Cylinders:
The Southern Implants Temporary Titanium Abutments are prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
| Form Approved: | OMB No. 0910-0120 |
|---|---|
| Expiration Date: | 06/30/2023 |
See PRA Statement below.
4
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 - K232418
Single Platform SP1 Implant System
Southern Implants (Pty) Ltd
December 01, 2023
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Southern Implants (Pty) Ltd
1 Albert Road
Irene, Gauteng, 0062 South Africa
Telephone: +27 12 667 1046
Fax: +27 12 667 1029 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Colin Saffy
Head of Regulatory Affairs and Quality
Email: colin.s@southernimplants.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Single Platform SP1 Implant System |
|---|---|
| Common Name | Dental implant |
| Classification Name | Endosseous dental implant |
| Classification Regulation | 21 CFR 872.3640, Class II |
| Product Code | DZE, NHA, PNP |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
PREDICATE DEVICE INFORMATION
Primary predicate devices:
K163194, Neodent Implant System – GM Line, JJGC Industria e Comercio de Materiais Dentarios SA.
Reference devices:
K190958, Neodent Implant System - GM Helix LG, JJGC Industria e Comercio de Materiais Dentarios SA. K163060, Deep Conical (DC) Implants and Accessories, Southern Implants (Pty) Ltd.
- K222457, Provata Implant System, Southern Implants (Pty) Ltd.
- K180536, Neodent Implant System GM Line, JJGC Industria e Comercio de Materiais Dentarios SA.
- K191191. Neodent Implant System Temporary Abutments, JJGC Industria e Comercio de Materiais Dentarios SA.
- K212785, Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments, Blue Sky Bio, LLC.
- K130991, NexxZRTM T and NexxZRTM T, Sagemax Bioceramics, Inc.
- K130436, Multilink Hybrid Abutment Cement, Ivoclar Vivadent, Inc.
INDICATIONS FOR USE STATEMENT
For the implants:
The Single Platform SP1 Implant System is 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. The
6
Single Platform SP1 Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved.
The Single Platform SP1 implants in lengths 20, 22 and 24 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
For the conventional abutment and screws:
The Conventional Abutments and Prosthetic Screws are premanufactured prosthetic components directly connected to endosseous dental imended for use in fully edentulous or partially edentulous maxilla and/or mandible to provide support for crowns, bridges or overdentures.
For the Titanium Abutment Bases (TIB) and Passive Abutments:
The TIB and Passive Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB and Passive 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.
For the Temporary Titanium Cylinders:
The Southern Implants Temporary Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
SUBJECT DEVICE DESCRIPTION
This submission includes fully threaded root-form dental implants with an internal cone and hexagon interface and mating abutments. The implants are provided in three diameters: Ø3.5, Ø4.0 and Ø5.0 mm. The implants are provided in a straight (0° angled) configuration only, with a 3.0 mm extended machined coronal section. The implants are provided in one prosthetic diameter (2.95 mm implants are provided in overall leneths of 8, 10, 11.5, 13, 16, 18 and 20 mm. The Ø4.0 mm implants are provided in overall lengths of 8, 10, 11.5, 13, 16, 18, 20, 22 and 24 mm. The Ø5.0 mm implants are provided in overall lengths of 8, 10, 11.5, 13, 16, and 18 mm.
This submission also includes: a Cover Screw, Healing Abutments in four diameters and multiple gingival heights, Titanium Cylinder Abutments for temporary restorations, Passive Abutments with a plastic burn-out component, Equator Overdenture Abutments in multiple gingival heights, Compact Conical Abutments in straight (0) and angled (17° and 30°) designs, TIB Abutment Bases, and abutment screws.
The Passive Abutments may be restored using either traditional cast-on workflows or digital CAD/CAM workflows using milled zirconia restorations (similar use to the TIB Abutment Bases).
Using the traditional cast-on workflow, the Passive Abutments function as 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, limited to a straight (0°) restoration when utilizing precious metal cast-on restorations.
Using digital CAD/CAM workflows, the TIB Abutment Bases and Passive Abutments function as two-piece abutment designs, consisting of standard premanufactured titanium alloy abutments for supporting the second half (or top-half) of the abutment, a hybrid/crown dental restoration and mesostructure (SageMaxx Zirconia) bonded with cement (Ivoclar Vivadent Multilink Hybrid cement). The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The TIB Abutment Bases and Passive Abutments then serves as the interface between the endosseous implant and the Zirconia restoration. The TIB Abutment Bases and Passive Abutments are designed to support the restoration on an endosseous implant in order to restore chewing function for the patient.
7
The mesostructured restoration is a CAD/CAM designed prosthesis milled out of Zirconia (SageMaxx 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 and a maximum allowable angulation of 20° for the mesostructured component.
All Single Platform SP1 implants are manufactured from unalloyed titanium conforming to ASTM F67, with a smooth machined collar (extended machined surface of 3 mm). The remainder of the entire endosseous threaded surface) is grit-blasted. The subject device implant material and surface is identical to the implants cleared in K222457 and K163060. The Cover Screw and Healing Abutments are manufactured from unalloyed titanium conforming to ASTM F67. The remaining Abutments are manufactured from titanium alloy conforming to ASTM F136. The abutment screws are manufactured from titanium alloy conforming to ASTM F136. 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 K222457 and K163060.
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence.
Non-clinical data submitted to demonstrate substantial equivalence includes: engineering analysis; dimensional analysis; sterilization validation according to ISO 11137-1, ISO 17665-1, ISO 17665-1, ISO 17665-2; bacterial endotoxin according to USP 39-NF 34; static and dynamic compression-bending according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants; scanning and milling validation for the Passive Abutments; and 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".
Non-clinical data referenced, or relied upon to demonstrate substantial equivalence includes: biocompatibility evaluations according to ISO 10993-1 (referenced from K222457 and K163060); sterile barrier shelf life (referenced from K222457); validated steam sterilization instructions per ISO 17665-2 (applicable to the Passive Abutments and Titanium Abutment Bases (TIB) which are provided non-sterile and intended for end-user sterilization - referenced from K193084); software validation testing as per the FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices (referenced from K193084); and scanning and milling validation for the Titanium Abutment Bases (TIB) (referenced from K193084).
No clinical data were included in this submission.
Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the 3Shape Abutment Designer Software (only applicable to the TIB Abutment Bases and Passive Abutments when using the digital CAD/CAM workflows for milled zirconia restoration design). Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the top half component of the two-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 and specifications 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'' (ASTM F2503, ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119) was performed on the previously cleared devices, K222457, PROVATA Implant System. The subject devices were compared to the predicate devices. The subject 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.
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 predicate devices listed above.
8
For the subject device Single Platform SP1 implants, the primary predicate device is K163194, and the reference devices are K190958, K163060, K222457 and K212785.
For the subject device Conventional Abutments and Prosthetic Screws for Single Platform SP1 implants, the reference devices are K163194, K163060 and K222457.
For the subject device TIB Abutment Bases and Passive Abutments for Single Platform SP1 implants, the reference devices are K222457, K180536 and K163060.
For the subject device Temporary Titanium Abutments for Single Platform SP1 implants, the reference devices are K222457 and K191191.
A comparison of the technological characteristics of the subject devices and the predicate devices is provided in the following tables.
9
| | Subject Device | Primary
Predicate
Device | Reference
Device | Reference
Device | Reference
Device | Reference
Device |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison | Single Platform
SP1 Implant
System
Southern
Implants (Pty)
Ltd | K163194
Neodent
Implant System
- GM Line
JJGC Industria
e Comercio de
Materiais
Dentarios SA | K190958
Neodent
Implant System - GM Helix LG
JJGC Industria
e Comercio de
Materiais
Dentarios SA | K163060
Deep Conical
(DC) Implants
and Accessories
Southern
Implants (Pty)
Ltd | K222457
Provata
Implant System
Southern
Implants (Pty)
Ltd | K212785
Blue Sky Bio
Dental Implant
System -
BIO MAX
MULTI ONE
Blue Sky Bio,
LLC |
| Implant | | | | | | |
| Indications
for Use
Statement | The
Single
Platform
SP1
Implant System is
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.
The
Single
Platform
SP1
Implant System is
intended
for
immediate function
when good primary
stability
with
appropriate
occlusal loading is
achieved.
The
Single
Platform
SP1
implants in lengths
20, 22 and 24 mm
when placed in the
maxilla are only
indicated
for
multiple
unit
restorations
in
splinted
applications
that
utilize at least two
implants. | The
Neodent
Implant System is
intended to be
surgically placed in
the bone of the
upper or lower jaw
to provide support
for prosthetic
devices such as
artificial teeth, to
restore chewing
function. It may be
used with single-
stage or two-stage
procedures, for
single or multiple
unit restorations,
and may be loaded
immediately when
good primary
stability is achieved
and with
appropriate
occlusal loading. | The
Neodent
Implant System is
intended to be
surgically placed in
the bone of the
upper or lower jaw
to provide support
for prosthetic
devices, such as
artificial teeth, to
restore chewing
function. It may be
used with single-
stage or two-stage
procedures, for
single or multiple
unit restorations,
and may be loaded
immediately when
good primary
stability is achieved
and with
appropriate
occlusal
loading.
The Neodent GM
Helix LG implants
can be placed
bicortically in cases
of reduced bone
density.
The
Neodent GM Helix
LG implants are
only indicated for
multiple unit
restorations in
splinted
applications that
utilize at least two
implants. | Southern Implants
Dental Implants are
intended for both
one- and two-stage
surgical procedures
in the following
situations and with
the following
clinical protocols: - replacing
single and
multiple
missing teeth
in the mandible
and maxilla, - immediate
placement in
extraction sites
and in
situations with
a partially or
completely
healed alveolar
ridge, - immediate
loading in all
indications,
except in
single tooth
situations on
implants
shorter than
8mm or in soft
bone (type IV)
where implant
stability may
be difficult to
obtain and
immediate
loading may
not be
appropriate.
The intended use
for 3.0 Deep
Conical implants is
limited to
replacement of
maxillary lateral
incisors and
mandibular
incisors. | The
Provata
Implant System is
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.
The
Provata
Implant System is
intended for
immediate function
when good primary
stability with
appropriate
occlusal loading is
achieved.
The intended use
for the 03.30
Provata implants is
limited to
replacement of
maxillary and
mandibular lateral
and central incisors.
The 12° angled Co-
Axis Provata
Implants are
intended to only be
used with straight
abutments. | Blue Sky Bio Multi
One Implant System
is intended for
surgical placement
in the bone of the
upper or lower jaw
to provide support
for prosthetic
devices to restore
chewing function.
Implants may be
used with single-
stage or two-stage
procedures.
They can be
loaded immediately when
good primary
stability is achieved
and with
appropriate occlusal
loading. Blue Sky
Bio Multi One
Implants are
indicated for multi-
unit restorations in
splinted
applications.
Blue
Sky Bio Multi One
Implant System
with a 45°
angulation 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. |
| Product
Code | DZE | DZE | DZE | DZE | DZE | DZE |
| Intended
Use | Functional
and esthetic
rehabilitation of
the edentulous
maxilla. | Root-form
implants
intended to
replace natural
tooth root. | Root-form
implants
intended to
replace natural
tooth root. | Bone anchored
dental prosthetic | Functional
and esthetic
rehabilitation of
the edentulous
maxilla. | Root-form
implants intended
to replace natural
tooth root. |
| Reason for
Predicate/
Reference | Not applicable | General implant
design, length
and diameter
Internal cone
and hex
connection | Implant lengths | General design
and diameter
Implant material
and surface
Sterility
Sterilization
Usage | Machined collar
Implant material
and surface
Shelf-life of
packaging
Sterility
Sterilization
Usage | Implant diameter
and length
combination |
10
| Item Code | MSC-SP35;
MSC-SP40;
MSC-SP50 | GM Helix | GM Helix LG | DCC35;
DCC40;
DCC50; DCT35;
DCT40; DCT50 | MSC-PRO300 | BIOMAX
MULTI ONE
Ø 3.25 mm
Straight |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------|
| Implant
Design | Fully threaded
tapered root-
form dental
implants | Threaded root-
form implant
with internal
GM Morse taper
connection with
internal hex | Threaded root-
form implant
with internal
GM Morse taper
connection with
internal hex | Fully threaded
cylindrical and
tapered root-
form dental
implants | Fully threaded
tapered root-
form dental
implants | One-piece
implant/abutment |
| Implant
Diameter | 3.50, 4.0 and 5.0
mm | 3.50, 3.75, 4.0,
4.3 and 5.0 mm | 3.75 and 4.0 mm | 3.52, 4.0 and
5.0mm | 3.30 mm | 3.25 mm |
| Implant
Length | For Ø3.5
implants: 8, 10,
11.5, 13, 16, 18,
20 mm
For Ø4.0
implants: 8, 10,
11.5, 13, 16, 18,
20, 22, 24 mm
For Ø5.0
implants: 8, 10,
11.5, 13, 16, 18
mm | 8, 10, 11.5, 13,
16, 18 mm | 20, 22, 25 mm | 8, 9, 11, 13, 15
mm | 8.5, 10, 11.5, 13,
15, 18 mm | 10, 11.5, 13, 16,
18, 20 mm |
| Platform
Angle,
Relative to
orthogonal
to implant
long axis | 0° (straight) | 0° (straight) | 0° (straight) | 0° (straight) | 0° (straight) | 0° (straight) |
| Implant
Platform
Diameter | For Ø3.5
implants: 3.30
mm
For Ø4.0
implants: 3.80
mm
For Ø5.0
implants: 4.50
mm | Not provided | Not provided | For Ø3.52 and
Ø4.0 implants:
3.10 mm
For Ø5.0
implants: 4.10
mm | 3.10 mm | 3.50 mm |
| Implant
Prosthetic
Diameter | 2.95 mm | Not provided | Not provided | For Ø3.52 and
Ø4.0 implants:
2.80 mm
For Ø5.0
implants: 3.83
mm | 2.90 mm | 3.50 mm |
| Implant
Interface | Internal Cone
and Hex | GM interface,
16° Morse taper
with anti-
rotational
features (Internal
cone and hex) | GM interface,
16° Morse taper
with anti-
rotational
features (Internal
cone and hex) | Deep Conical
(internal cone
and double hex) | Internal Hex | One piece |
| Implant
Material | Unalloyed
titanium (ASTM
F67) Grade 4,
and UTS ≥
900MPa (cold-
worked) | Unalloyed
titanium (ASTM
F67) Grade 4 | Unalloyed
titanium (ASTM
F67) Grade 4 | Unalloyed
titanium (ASTM
F67) Grade 4,
and UTS ≥
900MPa (cold-
worked) | Unalloyed
titanium (ASTM
F67) Grade 4,
and UTS ≥
900MPa (cold-
worked) | Ti-6Al-4V
Titanium Grade
5 alloy (ASTM
F136) |
| Implant
Endosseous
Surface | Grit-blasted with
a 3.0mm
machined
section only at
coronal end | Grit-blasted and
acid etched
(NeoPoros and
Acqua) | Grit-blasted and
acid etched
(NeoPoros) | Grit-blasted with
a 0.3mm
machined
section only at
coronal end | Grit-blasted with
a 3.0mm
machined
section only at
coronal end | Grit blasted and
acid etched |
| How Provided | | | | | | |
| Sterility | Provided sterile | Provided sterile | Provided sterile | Provided sterile | Provided sterile | Provided sterile |
| Sterilization | Gamma
irradiation | Gamma
irradiation | Gamma
irradiation | Gamma
irradiation | Gamma
irradiation | Gamma
irradiation |
| Usage | Single-patient,
single-use | Single-patient,
single-use | Not provided | Single-patient,
single-use | Single-patient,
single-use | Single-patient,
single-use |
| Shelf life of
packaging | 10 years | Not provided | Not provided | 5 years | 10 years | Not provided |
11
| Comparison | Subject Device | Primary Predicate Device
K163194 | Reference Device
K163060 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Conventional Abutments and | Neodent Implant System - GM | Deep Conical (DC) Implants and |
| | Prosthetic Screws for Single
Platform SP1 Implant System | Line
JJGC Industria e Comercio de | Accessories |
| | Southern Implants (Pty) Ltd | Materiais Dentarios SA | Southern Implants (Pty) Ltd |
| Indications for Use
Statement | The Conventional Abutments and
Prosthetic Screws are
premanufactured prosthetic
components directly connected to
endosseous dental implants and
intended for use in fully
edentulous or partially edentulous
maxilla and/or mandible to
provide support for crowns,
bridges or overdentures. | The Neodent Implant System is
intended to be surgically placed in
the bone of the upper or lower jaw
to provide support for prosthetic
devices such as artificial teeth, to
restore chewing function. It may be
used with single-stage or two-stage
procedures, for single or multiple
unit restorations, and may be
loaded immediately when good
primary stability is achieved and
with appropriate occlusal loading. | Southern Implants Dental Implants
are intended for both one- and two-
stage surgical procedures in the
following situations and with the
following clinical protocols:
- replacing single and multiple
missing teeth in the mandible
and maxilla, - immediate placement in
extraction sites and in situations
with a partially or completely
healed alveolar ridge, - immediate loading in all
indications, except in single
tooth situations on implants
shorter than 8mm or in soft bone
(type IV) where implant stability
may be difficult to obtain and
immediate loading may not be
appropriate.
The intended use for 3.0 Deep
Conical implants is limited to
replacement of maxillary lateral |
| | | | incisors and mandibular incisors. |
| Product Code | NHA | NHA | NHA |
| Intended Use | Functional and esthetic
rehabilitation of the edentulous
maxilla. | Immediate or conventional
rehabilitation procedures on the
maxilla or mandible. | Functional and esthetic
rehabilitation of the edentulous
maxilla. |
| Reason for
Predicate/ Reference | Not applicable | Cover Screw
Healing Abutment
Compact Conical Abutment
(general design and functioning) | Cover Screw
Healing Abutment
Compact Conical Abutment
Equator Overdenture Abutment
(general design and functioning) |
| Implant Connection | Internal Cone and Hex (SP1) | GM interface, 16° Morse taper
with anti-rotational features
(Internal cone and hex) | Deep Conical (internal cone and
double hex) |
| Cover Screw | | | |
| Item Code | CS-SP | GM Cover screw | CS-DC |
| Platform diameter | 2.95 mm | Not provided | 2.35, 2.85, 3.90 mm |
| Maximum diameter | 3.10 mm | Not provided | 2.38, 2.88, 3.93 mm |
| Abutment material | Unalloyed titanium (ASTM F67)
Grade 4 | Ti-6Al-4V ELI Titanium Alloy
(ASTM F136) | Unalloyed titanium (ASTM F67)
Grade 4 |
| Abutment surface | Machined | Machined and anodized | Machined and anodized |
| Healing Abutment | | | |
| Item Code | HA-SP | GM Healing abutment | HA-DC |
| Collar height | 2.5, 3.5, 4.5, 5.5 mm | 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm | 1.8, 3.8, 5.8 mm |
| Collar diameter | 4.5, 5.0, 5.5, 6.5 mm | 3.5, 4.5, 5.5, 6.5 mm | 4.5, 5.5, 6.5 mm |
| Abutment material | Unalloyed titanium (ASTM F67)
Grade 4 | Ti-6Al-4V ELI Titanium Alloy
(ASTM F136) | Unalloyed titanium (ASTM F67)
Grade 4 |
| Abutment surface | Machined and anodized | Machined and anodized | Machined and anodized |
| Equator Overdenture Abutment | | | |
| Item Code | EQ-SP | | EQ-DC |
| Connection
configurations | Non-engaging; Multi-unit | | Non-engaging; Multi-unit |
| Prosthesis
attachment | Removable | N/A | Removable |
| Collar height | 2.0, 4.0, 6.0 mm | | 2.0, 4.0, 6.0 mm |
| Collar diameter | 4.5 mm | | 3.5, 4.0 mm |
| Abutment angle | 0° | | 0° |
| Abutment material | Ti-6Al-4V Titanium Grade 5
alloy (ASTM F136) | GM Mini Conical Abutments | Ti-6Al-4V Titanium Grade 5 alloy
(ASTM F136) |
| Abutment surface | Machined with TiN coating | Machined | Machined with TiN coating |
| Compact Conical Abutment | | | |
| Item Code | MC-SP; MC-SP-17D; MC-SP-
30D | GM Mini Conical Abutments | MC-DC |
| Connection
configurations | 0°: Non-engaging; Multi-unit
17° and 30°: Engaging; Multi-unit | 0°: Non-engaging; Multi-unit
17° and 30°: Engaging; Multi-unit | Non-engaging; Multi-unit |
| Prosthesis
attachment | Screw-retained | Screw-retained | Screw-retained |
| Collar height | 0°: 1.5, 2.5, 3.5, 4.5 mm
17°: 1.5, 2.5, 3.5 mm (low side
height)
30°: 2.5, 3.5 mm (low side height) | 0°: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm
17° and 30°: 1.5, 2.5, 3.5 mm | 1.5, 3.0, 4.0, 5.0 mm |
| Collar diameter | 4.8 mm | 4.8 mm | 4.8, 6.0 mm |
| Abutment angle | 0°, 17°, 30° | 0°, 17°, 30° | 0° |
| Abutment material | Ti-6Al-4V Titanium Grade 5
alloy (ASTM F136) | Ti-6Al-4V ELI Titanium Alloy
(ASTM F136) | Ti-6Al-4V Titanium Grade 5 alloy
(ASTM F136) |
| Abutment surface | Machined with TiN coating | Machined | Machined with TiN coating |
| Abutment screw
material | Ti-6Al-4V Titanium Grade 5
alloy (ASTM F136) | Not provided | Ti-6Al-4V Titanium Grade 5 alloy
(ASTM F136) |
| How Provided | | | |
| Sterility | Provided sterile | Sterile | Provided sterile |
| Sterilization | Gamma irradiation | Ethylene Oxide | Gamma irradiation |
| Usage | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use |
| Shelf life of
packaging | 5 years | Not provided | 5 years |
12
13
| Subject Device | Reference Device | |
|---|---|---|
| K222457 | ||
| Comparison | TIB Abutment Bases and Passive Abutments | |
| for Single Platform SP1 Implant System | TIB Abutment Bases and Passive Abutments | |
| for Ø3.30 Provata Implant System | ||
| Southern Implants (Pty) Ltd | Southern Implants (Pty) Ltd | |
| Indications for Use | ||
| Statement | The TIB and Passive Abutments are | |
| premanufactured prosthetic components directly | ||
| connected to endosseous dental implants and are | ||
| intended for use as an aid in prosthetic | ||
| rehabilitation. The TIB and Passive 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. | 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. | ||
| Product Code | NHA, PNP | NHA, PNP |
| Intended Use | Functional and esthetic rehabilitation of the | |
| edentulous maxilla. | Functional and esthetic rehabilitation of the | |
| edentulous maxilla. | ||
| Reason for Predicate/ | ||
| Reference | Not applicable | TIB Abutment |
| Passive Abutment | ||
| (general design and functioning) | ||
| Software Compatibility | ||
| Implant Connection | Internal Cone and Hex (SP1) | Internal Hex |
| TIB Abutment Base | ||
| Item Code | TIB-SP; TIB-NSP; TIB-SP-PM | TIBS-3M-C1.5 |
| TIBS-3M-C3 | ||
| Abutment design | 2 Piece - Premanufactured titanium abutment, | |
| mounted onto the implant and fixed with a screw. | ||
| SageMaxx Zirconia (K130991) hybrid/crown | ||
| restoration milled and bonded to the titanium | ||
| abutment. | 2 Piece - Premanufactured titanium abutment, | |
| mounted onto the implant and fixed with a screw. | ||
| SageMaxx Zirconia (K130991) hybrid/crown | ||
| restoration milled and bonded to the titanium | ||
| abutment. | ||
| Collar height | 1.5, 3.0 mm | 1.5, 3.0 mm |
| Maximum abutment angle | 20° | 20° |
| Post height | Minimum 4.5 mm | Minimum 4.5 mm |
| Abutment Restorative | ||
| Platform Diameter | 4.50, 5.50 mm | 3.85 mm |
| Abutment titanium base | ||
| component material | Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136) | Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136) |
| Abutment surface | Machined and anodized | Machined and anodized |
| Abutment screw material | Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136) | Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136) |
| Passive Abutment | ||
| Item Code | PA-SP; PA-NSP; PA-SP-PM | PA-3EM-STC; PA-3NM-STC |
| Connection configurations | Engaging and non-engaging; Single-unit and | |
| multi-unit | Engaging and non-engaging; Single-unit and | |
| multi-unit | ||
| Prosthesis attachment | Screw-retained | Screw-retained |
| Collar height | 1.0 mm | 0.4 mm |
| Collar diameter | 3.9, 5.0 mm | 3 mm |
| Maximum abutment angle | 20° for zirconia restorations (digital CAD/CAM | |
| workflows) | ||
| 0° for precious metal cast-on restorations | ||
| (traditional workflows) | 0° | |
| Abutment titanium base | ||
| component material | Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136) | Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136) |
| Abutment surface | Machined and anodized | Machined |
| Abutment screw material | Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136) | Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136) |
| CAD/CAM Process | ||
| Restoration material | Zirconia - Sage Maxx NexxZr (K130991) | Zirconia - Sage Maxx NexxZr (K130991) |
| CAD/CAM Design | ||
| Workflow | 3Shape E3 Desktop Scanner (3Shape A/S) | |
| 3Shape Abutment Designer Software | 3Shape E3 Desktop Scanner (3Shape A/S) | |
| 3Shape Abutment Designer Software | ||
| CAD/CAM Manufacturing | ||
| Workflow | WorkNC CAM software, Roland DWX51D | |
| milling unit | WorkNC CAM software, Roland DWX51D | |
| milling unit | ||
| How Provided | ||
| Sterility | Provided non-sterile | Provided non-sterile |
| Usage | Single-patient, single-use | Single-patient, single-use |
| Shelf life of packaging | 5 years | 5 years |
14
15
| Subject Device | Reference Device | |
|---|---|---|
| Comparison | K222457 | |
| Temporary Titanium Abutments for Single | ||
| Platform SP1 Implant System | Temporary Titanium Abutments for Ø3.30 | |
| Provata Implant System | ||
| Southern Implants (Pty) Ltd | Southern Implants (Pty) Ltd | |
| Indications for Use | ||
| Statement | The Southern Implants Temporary Titanium | |
| Abutments are premanufactured prosthetic | ||
| components directly connected to endosseous | ||
| dental implants and are intended for provisional | ||
| use up to 180 days as an aid in prosthetic | ||
| rehabilitation. | The Southern Implants Temporary Titanium | |
| Abutments are premanufactured prosthetic | ||
| components directly connected to endosseous | ||
| dental implants and are intended for provisional | ||
| use up to 180 days as an aid in prosthetic | ||
| rehabilitation. | ||
| Product Code | NHA | NHA |
| Intended Use | Functional and esthetic rehabilitation of the | |
| edentulous maxilla. | Functional and esthetic rehabilitation of the | |
| edentulous maxilla. | ||
| Reason for | ||
| Predicate/Reference | Not applicable | Titanium Cylinder Abutment (general abutment |
| design) | ||
| Abutment and screw materials and surface | ||
| Shelf-life of packaging | ||
| Sterility status and Sterilization Method | ||
| Usage | ||
| Implant Connection | Internal Cone and Hex (SP1) | Internal Hex |
| Titanium Cylinder Abutment | ||
| Item Code | TC-SP; TC-NSP; TC-SP-PM | TC-3M; TC-3NM |
| Connection configurations | Engaging and non-engaging; Single-unit and | |
| multi-unit | Engaging and non-engaging; Single-unit and | |
| multi-unit | ||
| Prosthesis attachment | Cement-retained | Cement-retained |
| Collar height | 1.5 mm | 2.0 mm |
| Collar diameter | 4.5, 5.5 mm | 3.5 mm |
| Abutment angle | 0° | 0° |
| Abutment material | Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136) | Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136) |
| Abutment surface | Machined and anodized | Machined and anodized |
| Abutment screw material | Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136) | Ti-6Al-4V Titanium Grade 5 alloy (ASTM F136) |
| Duration of use | 180 days | 180 days |
| How Provided | ||
| Sterility | Provided sterile | Provided sterile |
| Sterilization | Gamma irradiation | Gamma irradiation |
| Usage | Single-patient, single-use | Single-patient, single-use |
| Shelf life of packaging | 5 years | 5 years |
16
The Indications for Use Statements for the subject device implants and the reference device K222457 are similar with the subject device statement including a restriction for the longer length implants (i.e., lengths 20 - 24 mm) to be splinted in multiple-unit restorations. This restriction is similar to that of reference devices K190958 and K212785.
The Indications for Use Statements for the subject device abutments and the reference device K222457 are identical for the Conventional Abutments and Prosthetic screws, the TIB Abutment Bases, and the Temporary Titanium Abutments.
For the subject device Single Platform SP1 implants, the primary predicate device is K163194, and the reference devices are K190958, K163060, K222457 and K212785. The primary predicate device K163194 is for substantial equivalence of the subject device implant connection interface, implant lengths, and general designs. The subject device implants have a similar internal cone and hex connection, similar implant diameters and lengths as implants in K163194. The reference device K190958 is for substantial equivalence of the subject device implant longer lengths of 20 – 24 mm. The subject device implants' indications for use is limited to splinted multiple-unit restorations for the longer length implants (i.e., lengths 20 - 24mm) which is similar to the indications for use of reference device K190958. The subject device implants' indications for use is similar to reference device K222457, with the reference device having an additional limitation for narrow diameter implants (