(124 days)
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, 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.
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)
- Intra-oral scanner: 3Shape E3 Desktop Scanner
- Abutment design software: 3Shape Abutment Designer Software (K151455)
- Milling machine: Roland DWX51D Milling Unit
The provided text describes the Angulated Screw Channel (ASC) Solution Abutments and SI-BASE Abutments for dental implants. The document is a 510(k) summary submitted to the FDA to demonstrate substantial equivalence to legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner with defined thresholds. Instead, it demonstrates compliance through comparison to predicate devices and adherence to relevant standards and guidance documents. The "reported device performance" is largely qualitative and comparative, focusing on demonstrating equivalence rather than meeting specific numerical performance targets.
However, based on the "PERFORMANCE DATA" section and "Table of Substantial Equivalence", we can infer the following:
| Acceptance Criteria (Inferred from regulatory requirements and predicate comparison) | Reported Device Performance (as demonstrated by the study) |
|---|---|
| Biocompatibility: Meet FDA Guidance Document for ISO 10993-1 and ISO 10993-5 (In-Vitro Cytotoxicity) | Materials are identical in formulation, processing, component interactions, and storage conditions to predicate device K193084. Performed biocompatibility testing per ISO 10993-1. |
| Sterilization: Validation per ISO 17665-1 and ISO 17665-2 | Validated sterilization instructions per ISO 17665-1 and ISO 17665-2 (though the device is provided non-sterile, indicating the sterilization protocol is for other components or processes). |
| Software Validation: Meet FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices | Software validation testing performed per FDA Guidance Document. Verification and validation testing conducted for the abutment design library to demonstrate that restrictions prevent design outside allowable limitations. |
| Mechanical Performance (Fatigue): Meet ISO 14801 (dynamic compression-bending) | Dynamic testing performed on worst-case subject device constructs. Results demonstrated fatigue performance exceeding its indication and supported by bench testing previously cleared in K173706 and K222457. |
| MR Safety: Meet FDA Guidance Document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" | MR safety testing performed on previously cleared devices (K222457). Subject devices compared to predicates and considered "equally MR Safe" as they are not worst-case in terms of material, size, or shape. |
| Design Workflow: Equivalent design and manufacturing workflows to predicates | Uses the same scanners (3Shape E3 Desktop Scanner) and software (3Shape Abutment Designer Software, WorkNC CAM software) and milling unit (Roland DWX51D) as the primary predicate. |
| Material Equivalence: Identical or similar materials to predicates | Titanium Grade 5 Alloy (ASTM F136) for abutments and screws, Zirconia (Sage Maxx NexxZr, K130991) for restoration material, consistent with predicates. |
| Indications for Use: Similar to predicate and reference devices | Indications for use statement is very similar to predicate and reference devices, differing only in device name and specific application paragraphs, but expressing shared intended use. |
2. Sample sizes used for the test set and the data provenance
- Sample Sizes for Test Set:
- Biocompatibility: Not explicitly stated as a number of devices. The statement mentions "materials are identical in formulation, processing, component interactions, and storage conditions to the predicate device" and "biocompatibility testing per the FDA Guidance Document for Use of Standard ISO 10993-1... and ISO 10993-5 'Biological Evaluation of Medical Devices - Part 5: Tests for In-Vitro Cytotoxicity' was performed." This implies biological samples were used for in-vitro cytotoxicity, but the number is not specified.
- Mechanical Performance (Fatigue): "Dynamic testing was performed on worst-case subject device constructs." The exact number is not provided, but typically, mechanical fatigue testing involves a statistically significant number of samples per "worst-case construct" to establish fatigue limits.
- Software Validation: Not explicitly stated as a numerical sample size. It involved verification and validation for the "abutment design library" and screenshots under user verification testing, indicating a functional test rather than a numerical sample size.
- MR Safety: Not explicitly stated for the subject device. It refers to testing performed on "previously cleared devices, K222457, PROVATA Implant System."
- Data Provenance: Not explicitly stated for any of the tests. Given it's a 510(k) summary, the testing was likely conducted by or on behalf of Southern Implants (Pty) Ltd, which is located in "Irene, Gauteng, 0062 South Africa." The studies appear to be non-clinical (bench testing) and retrospective in the sense that they rely on comparisons to previously cleared devices and established standards, rather than new prospective human clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The studies described are primarily non-clinical bench testing, software validation, and biocompatibility assessments, which typically do not involve establishing "ground truth" through expert consensus in the way a diagnostic AI device would. Instead, performance is measured against engineering specifications, standards (like ISO 14801), and equivalence to predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable to the types of non-clinical, hardware-focused studies described. Adjudication methods are typically used in clinical studies or studies evaluating subjective interpretations (e.g., image reading) to establish a consensus ground truth.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There was no MRMC comparative effectiveness study and no mention of AI assistance. This device is a component for dental implants (abutments), not a diagnostic AI system or an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical component (dental abutment) and related software for design. While software validation was performed, it's for design limitations and functionality, not for an "algorithm only" performance in a diagnostic or interpretive sense. The "standalone" concept typically applies to AI algorithms that provide a diagnosis or interpretation without human intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as it applies to diagnostic or prognostic data is not directly applicable to these non-clinical studies. Instead, the "truth" or reference for the tests described is:
- Biocompatibility: Established biological safety standards (ISO 10993-1, ISO 10993-5) and comparison to predicate device materials.
- Mechanical Performance: International standard ISO 14801 for dynamic fatigue testing of dental implants and abutments. This involves objective physical measurements.
- Software Validation: Functional specifications of the software and demonstration that defined design limitations are enforced.
- MR Safety: FDA guidance document recommendations and physical testing methods to determine MR compatibility.
8. The sample size for the training set
This information is not applicable. This device is not an AI diagnostic or predictive algorithm that requires a training set in the conventional sense. The "design workflow" involves CAD/CAM software but this refers to a process for custom fabrication, not machine learning model training.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
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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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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
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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) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------- |
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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) Ltd1 Albert RoadIrene, Gauteng, 0062 South AfricaTelephone +27 12 667 1046Fax +27 12 667 1029 |
|---|---|
| Official Contact | Colin A. SaffyHead 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.
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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) .
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- 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:
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| Subject Device | Primary Predicate Device | Reference Device | Reference Device | |
|---|---|---|---|---|
| Comparison | Angulated Screw Channel (ASC)Abutment System and SI-BASEAbutment SystemSouthern Implants (Pty) Ltd(External Hex ASC Abutments) | K193084TIB Abutment SystemSouthern Implants (Pty) Ltd | K173706Piccolo Implants and AccessoriesSouthern Implants (Pty) Ltd | K163634External Hex ImplantsSouthern Implants (Pty) Ltd |
| Indications for UseStatement | The Angulated Screw Channel (ASC)Solution Abutments and SI-BASEAbutments are premanufacturedprosthetic components directlyconnected to endosseous dental implantsand are intended for use as an aid inprosthetic rehabilitation. The ASCSolution Abutments and SI-BASEAbutments consist of two major parts.Specifically, the titanium base andmesostructure components make up amulti-piece abutment. The systemintegrates multiple components of thedigital dentistry workflow: Scan filesfrom desktop scanners, CAD software,CAM software, ceramic material,milling machine and associated toolingand accessories.The intended use for the engaging ASCSolution Abutments and SI-BASEAbutments used with the Ø3.0 External-Hex implants are intended for use with astraight mesostructure component.The intended use for the engaging ASCSolution Abutments and SI-BASEAbutments used with the Ø3.4 and Ø4.0External-Hex implants is limited toreplacement of maxillary andmandibular lateral and central incisors. | The TIB Abutments are premanufacturedprosthetic components directly connectedto endosseous dental implants and areintended for use as an aid in prostheticrehabilitation. The TIB abutments consistsof two major parts. Specifically, thetitanium base and mesostructurecomponents make up a two-pieceabutment. The system integrates multiplecomponents of the digital dentistryworkflow: Scan files from desktopscanners, CAD software, CAM software,ceramic material, milling machine andassociated tooling and accessories. | The Piccolo Implants and Accessories areintended for both one- and two-stage surgicalprocedures in the following situations and with thefollowing clinical protocols:· replacing maxillary lateral incisors andmandibular incisors,· immediate placement in extraction sites and insituations with a partially or completely healedalveolar ridge,· immediate loading when good primary stabilitywith appropriate occlusal loading is achieved,except in soft bone (type IV) where implantstability may be difficult to obtain. | Southern Implants' External Hex Implantsare intended for surgical placement in theupper or lower jaw to provide a means forprosthetic attachment of crowns, bridges oroverdentures utilizing delayed or immediateloading. Southern Implants' External HexImplants are intended for immediatefunction when good primary stability withappropriate occlusal loading is achieved. |
| Product Code | NHA, PNP | NHA, PNP | DZE, NHA | DZE, NHA |
| Reason forPredicate/Reference | n/a | Abutment (general design and functioning)Software CompatibilityAbutment Connection Type and Size | Ø3.0 External Hex Abutment Connection Typeand SizeAbutment Surface | External Hex Abutment Connection Typeand SizeAbutment Post Height |
| Abutment Types | External Hex Angulated ScrewChannelsExternal Hex SI-BASE Abutments | External Hex TiBase Abutments | Piccolo Abutments | Straight titanium abutments:Titanium cylindersAnatomic abutments |
| Prothesis Attachment | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained |
| Restoration | Single-unit | Single-unit | Single-unit | Single-unit |
| Abutment ConnectionInterface | Southern Implants External Hex | Southern Implants External Hex | Southern Implants External Hex | Southern Implants External Hex |
| Abutment ConnectionInterface Diameters | Ø3.00 to Ø4.07 | Ø3.43 to Ø4.07 | 03.00 | Ø3.43 to Ø4.07 |
| Abutment RestorativePlatform Diameter | Ø4.00 to Ø4.60 | Ø4.30 to Ø5.10 | 03.5 | Ø3.40 to Ø4.05 |
| Collar/GingivalHeight | 1.5mm | 0.6, 1.5 or 3mm | 0.6, 0.75 or 1 mm | 1mm to 5mm |
| Abutment PostHeight | 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) orTitanium Grade 4 (ASTM F67) or Gold Alloy | Titanium Grade 5 Alloy (ASTM F136) orTitanium Grade 4 (ASTM F67) or GoldAlloy |
| Abutment Surface | Machined | Machined | Machined | Machined |
| Knurled (grooved)Titanium nitride coated | Knurled (grooved)Anodized | Knurled (grooved)Titanium nitride coated | Knurled (grooved) and smoothTitanium nitride coated | |
| Restoration Material | Zirconia - Sage Maxx NexxZr(K130991) | Zirconia - Sage Maxx NexxZr (K130991) | n/a | n/a |
| MaximumRestoration Angle | 20° | 20° | 20° | 20° |
| Screw Material | Titanium Grade 5 Alloy (ASTM F136) | Titanium Grade 5 Alloy (ASTM F136) | Titanium Grade 5 Alloy (ASTM F136) | Titanium Grade 5 Alloy (ASTM F136) |
| Screw Thread | M1.6, M2 | 1-72 unf-2b, M1.6, M1.8 and M2 | M1.6 | M2.0 |
| CAD/CAM DesignWorkflow | 3Shape E3 Desktop Scanner (3ShapeA/S)3Shape Abutment Designer Software | 3Shape E3 Desktop Scanner (3Shape A/S)3Shape Abutment Designer Software | n/a | n/a |
| CAD/CAMManufacturingWorkflow | WorkNC CAM software, RolandDWX51D milling unit | WorkNC CAM software, RolandDWX51D milling unit | n/a | n/a |
| How Provided | ||||
| Sterility | Non-sterile | Non-sterile | Sterile: Titanium AbutmentsNon-sterile: Gold Abutments, Passive Abutments | Sterile: Titanium Abutments |
| Usage | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use |
| Subject Device | Primary Predicate Device | Reference Device | Reference Device | |
| Comparison | Angulated Screw Channel (ASC)Abutment System and SI-BASEAbutment SystemSouthern Implants (Pty) Ltd(Internal Connection ASCAbutments) | K193084TIB Abutment SystemSouthern Implants (Pty) Ltd | K222457PROVATA Implant SystemSouthern Implants (Pty) Ltd | K163634External Hex ImplantsSouthern Implants (Pty) Ltd |
| Indications for UseStatement | The Angulated Screw Channel (ASC)Solution Abutments and SI-BASEAbutments are premanufacturedprosthetic components directlyconnected to endosseous dentalimplants and are intended for use as anaid in prosthetic rehabilitation. TheASC Solution Abutments and SI-BASE Abutments consist of two majorparts. Specifically, the titanium baseand mesostructure components makeup a multi-piece abutment. The systemintegrates multiple components of thedigital dentistry workflow: Scan filesfrom desktop scanners, CAD software,CAM software, ceramic material,milling machine and associated toolingand accessories.The intended use for the engagingASC Solution Abutments and SI-BASE Abutments used with the Ø3.3PROVATA implants and Ø3.5/Ø4.0Deep Conical implants are intended foruse with a straight mesostructurecomponent.The intended use for the engagingASC Solution Abutments and SI-BASE Abutments used with thePROVATA implants and Ø3.5 andØ4.3 TRI-NEX implants is limited toreplacement of maxillary andmandibular lateral and central incisors. | The TIB Abutments are premanufacturedprosthetic components directly connectedto endosseous dental implants and areintended for use as an aid in prostheticrehabilitation. The TIB abutments consistsof two major parts. Specifically, thetitanium base and mesostructurecomponents make up a two-pieceabutment. The system integrates multiplecomponents of the digital dentistryworkflow: Scan files from desktopscanners, CAD software, CAM software,ceramic material, milling machine andassociated tooling and accessories. | The Provata Implant System is intendedfor surgical placement in the upper orlower jaw to provide a means forprosthetic attachment of crowns, bridgesor overdentures utilizing delayed orimmediate loading. The Provata ImplantSystem is intended for immediatefunction when good primary stabilitywith appropriate occlusal loading isachieved.The intended use for the 03.30 Provataimplants is limited to replacement ofmaxillary and mandibular lateral andcentral incisors. The 12° angled Co-AxisProvata Implants are intended to only beused with straight abutments.The TIB Abutments arepremanufactured prosthetic componentsdirectly connected to endosseous dentalimplants and are intended for use as anaid in prosthetic rehabilitation. The TIBabutments consist of two major parts.Specifically, the titanium base andmesostructure components make up atwo-piece abutment. The systemintegrates multiple components of thedigital dentistry workflow: Scan filesfrom desktop scanners, CAD software,CAM software, ceramic material,milling machine and associated toolingand accessories. | Southern Implants' External HexImplants are intended for surgicalplacement in the upper or lower jaw toprovide a means for prostheticattachment of crowns, bridges oroverdentures utilizing delayed orimmediate loading. Southern Implants'External Hex Implants are intended forimmediate function when good primarystability with appropriate occlusalloading is achieved. |
| Product Code | NHA, PNP | NHA, PNP | NHA, PNP | DZE, NHA |
| Reason forPredicate/Reference | n/a | Abutment (general design and functioning)Software CompatibilityAbutment Connection Type and Size | Internal Hex Abutment Connection Typeand Size | Abutment materialSurface treatmentPackaging methods |
| Abutment Types | All Southern Implants Internal HexAngulated Screw Channel AbutmentsAll Southern Implants Internal Hex SI-BASE Abutments | All Southern Implants Internal Hex TiBaseAbutments | Narrow PROVATA TiBase Abutment | Compact Conical Abutments |
| Prothesis Attachment | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Screw-retained |
| Restoration | Single-unit | Single-unit | Single-unit | Multi-unit |
| Abutment ConnectionInterface | Southern Implants Internal HexConnections | Southern Implants Internal HexConnections | Southern Implants Internal HexConnections | Southern Implants External Hex |
| Abutment ConnectionInterface Diameters | Ø3.30 to Ø4.07 | Ø3.50 to Ø4.30 | Ø3.30 | Ø3.0, 3.43, 4.05, 5.0 and 6.0mm |
| Abutment RestorativePlatform Diameter | Ø4.00 to Ø4.60 | Ø4.30 to Ø5.00 | Ø3.85 | Ø4.8 and Ø6.0 |
| Collar/GingivalHeight | 1.5mm | 0.6 to 3mm | 1.5mm or 3mm | 1.58, 2, 3, 4, and 5.5mm |
| Abutment PostHeight | Minimum 4.5mm | Minimum 4.5mm | Minimum 4.5mm | n/a |
| Abutment Angulation | 0° | 0° | 0° | 0° - 30° |
| Abutment Material | Titanium Grade 5 Alloy (ASTM F136) | Titanium Grade 5 Alloy (ASTM F136) | Titanium Grade 5 Alloy (ASTM F136) | Titanium Grade 5 Alloy (ASTM F136) |
| Abutment Surface | MachinedKnurled (grooved)Titanium nitride coatedAnodized | MachinedKnurled (grooved)Anodized | MachinedKnurled (grooved)Anodized | MachinedTitanium nitride coated |
| Restoration Material | Zirconia - Sage Maxx NexxZr(K130991) | Zirconia - Sage Maxx NexxZr (K130991) | Zirconia - Sage Maxx NexxZr(K130991) | n/a |
| MaximumRestoration Angle | 20° | 20° | 20° | n/a |
| Screw Material | Titanium Grade 5 Alloy (ASTM F136) | Titanium Grade 5 Alloy (ASTM F136) | Titanium Grade 5 Alloy (ASTM F136) | Titanium Grade 5 Alloy (ASTM F136) |
| Screw Thread | 1-72 unf-2b, M1.6, M1.8, M2 | 1-72 unf-2b, M1.6, M1.8 and M2 | M1.6 | M1.4 |
| CAD/CAM DesignWorkflow | 3Shape E3 Desktop Scanner (3ShapeA/S)3 Shape Abutment Designer Software | 3Shape E3 Desktop Scanner (3Shape A/S)3Shape Abutment Designer Software | 3Shape E3 Desktop Scanner (3ShapeA/S)3Shape Abutment Designer Software | n/a |
| CAD/CAMManufacturingWorkflow | WorkNC CAM software, RolandDWX51D milling unit | WorkNC CAM software, RolandDWX51D milling unit | WorkNC CAM software. RolandDWX51D milling unit | n/a |
| How Provided | ||||
| Sterility | Non-sterile | Non-sterile | Non-sterile | Sterile |
| Usage | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use |
| Subject Device | Reference Device | Primary Predicate Device | Reference Device | |
| Comparison | Angulated Screw Channel (ASC)Abutment System and SI-BASEAbutment SystemSouthern Implants (Pty) Ltd(Internal Connection ASCAbutments) | K053478/K070905Endosseous Implant and AccessoriesNorthern Implants (Pty) Ltd/ SouthernImplants (Pty) Ltd | K193084TIB Abutment SystemSouthern Implants (Pty) Ltd | K163634External Hex ImplantsSouthern Implants (Pty) Ltd |
| Indications for UseStatement | The Angulated Screw Channel (ASC)Solution Abutments and SI-BASEAbutments are premanufacturedprosthetic components directlyconnected to endosseous dentalimplants and are intended for use asan aid in prosthetic rehabilitation. TheASC Solution Abutments and SI-BASE Abutments consist of twomajor parts. Specifically, the titaniumbase and mesostructure componentsmake up a multi-piece abutment. Thesystem integrates multiplecomponents of the digital dentistryworkflow: Scan files from desktopscanners, CAD software, CAMsoftware, ceramic material, millingmachine and associated tooling andaccessories.The ASC Solution Abutments and SI-BASE Abutments for CompactConical Abutments are intended foruse on straight Compact ConicalAbutments with a straightmesostructure component. | The NSI Implant System is intended tobe implanted in the upper or lower jawarches to provide support for fixed orremovable dental prostheses in a singletooth, partially edentulous protheses, orfull arch protheses. It further adds theoption for immediate loading on singleand splinted multiple unit restorationswhen good primary stability is achievedand with appropriate occlusal loading, torestore chewing function. | The TIB Abutments are premanufacturedprosthetic components directly connectedto endosseous dental implants and areintended for use as an aid in prostheticrehabilitation. The TIB abutmentsconsists of two major parts. Specifically,the titanium base and mesostructurecomponents make up a two-pieceabutment. The system integrates multiplecomponents of the digital dentistryworkflow: Scan files from desktopscanners, CAD software, CAM software,ceramic material, milling machine andassociated tooling and accessories. | Southern Implants' External HexImplants are intended for surgicalplacement in the upper or lower jaw toprovide a means for prostheticattachment of crowns, bridges oroverdentures utilizing delayed orimmediate loading. Southern Implants'External Hex Implants are intended forimmediate function when good primarystability with appropriate occlusalloading is achieved. |
| Product Code | NHA, PNP | DZE | NHA, PNP | DZE, NHA |
| Reason forPredicate/Reference | n/a | Abutment (general design andfunctioning)Abutment Connection Type and SizeAbutment material | Software CompatibilitySterility | Abutment materialSurface treatmentPackaging methods |
| Abutment Type | Angulated Screw Channel CompactConical AbutmentsSI-BASE Compact ConicalAbutments | Titanium Cylinders for Compact ConicalAbutmentsCompact Conical Abutments | All non-engaging TIB Abutments | Compact Conical Abutments |
| Prosthesis Attachment | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Screw-retained |
Table of Substantial Equivalence – External Hex ASC Solution and SI-BASE Abutments
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Table of Substantial Equivalence – Internal Connection ASC Solution and SI-BASE Abutments
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Table of Substantial Equivalence – Compact Conical ASC Solution Abutments and SI-BASE Abutments
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| Restoration | Multi-unit | Multi-unit | Single-unit | Multi-unit | ||
|---|---|---|---|---|---|---|
| AbutmentConnection Interface | Ø4.8 Compact ConicalØ6.0 Compact Conical | Ø4.8 Compact ConicalØ6.0 Compact Conical | All Southern Implants Connection Types | External Hex (Ø3.0, 3.43, 4.05, 5.0 and6.0mm) | ||
| AbutmentRestorative PlatformDiameter | Ø5.20 and Ø6.40 | Ø5.20 and Ø6.40 | Varying | Ø4.8 and Ø6.0 | ||
| Collar/GingivalHeight | 1mm | 1mm | 0.6, 1.5 or 3mm | 1.58, 2, 3, 4, and 5.5mm | ||
| Abutment PostHeight | Minimum 4.5mm | n/a | Minimum 4.5mm | n/a | ||
| AbutmentAngulation | 0° | 0° | 0° | 0° | ||
| Abutment Material | Titanium Grade 5 Alloy (ASTMF136) | Titanium Grade 3 (ASTM F67) | Titanium Grade 5 Alloy (ASTM F136) | Titanium Grade 5 Alloy (ASTM F136) | ||
| Abutment Surface | MachinedKnurled (grooved)Titanium nitride coatedAnodized | MachinedKnurled (grooved) | MachinedKnurled (grooved)Anodized | MachinedKnurled (grooved)Titanium nitride coated | ||
| Restoration Material | Zirconia - Sage Maxx NexxZr(K130991) | n/a | Zirconia - Sage Maxx NexxZr (K130991) | n/a | ||
| MaximumRestoration Angle | 0° | 20° | 20° | n/a | ||
| Screw Material | Titanium Grade 5 Alloy (ASTMF136) | Titanium Grade 5 Alloy (ASTM F136) | Titanium Grade 5 Alloy (ASTM F136) | Titanium Grade 5 Alloy (ASTM F136) | ||
| Screw Thread | M1.4 | M1.4 | Varying | M1.4 | ||
| CAD/CAM DesignWorkflow | 3Shape E3 Desktop Scanner (3ShapeA/S)3Shape Abutment Designer Software | n/a | 3Shape E3 Desktop Scanner (3ShapeA/S)3Shape Abutment Designer Software | n/a | ||
| CAD/CAMManufacturingWorkflow | WorkNC CAM software, RolandDWX51D milling unit | n/a | WorkNC CAM software, RolandDWX51D milling unit | n/a | ||
| How Provided | ||||||
| Sterility | Non-Sterile | Sterile | Non-sterile | Sterile | ||
| Usage | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use |
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The Indications for Use Statement for the subject devices is very similar to the predicate device and reference devices, differing in device name and the addition of paragraphs stating the intended use of the various subject devices. The subject and predicate device Indications for Use statements have identical wording regarding the system integration of the devices into digital dentistry workflows. The Indications for Use Statements of the reference predicates K173706 and K222457, cover the additional paragraphs specified in the subject device's Indication for Use Statement. K222457 covers the indications limited to replacement of maxillary and mandibular lateral and central incisors, whereas K173706 covers indications for use with a straight mesostructure component.
The subject device's Indications for Use Statement combines the relevant features of both predicate and reference Indications for Use statements. These minor differences do not raise new concerns of safety, effectiveness or substantial equivalence as the combined Indications for Use Statements express shared intended use.
The primary predicate device K193084 is for substantial equivalence of the subject device abutment designs and abutment connection types. The subject device abutments have the similar designs, identical connection types and are both two-piece abutments with a premanufactured titanium base making up the first piece, and a ceramic composite intended to be bonded to the titanium base making up the second piece of the abutment. Design differences are covered by specified reference predicate devices. The abutment design is thus substantially equivalent to that of the primary predicate and reference predicates.
The primary predicate and the subject devices have the identical maximum angulation for the ceramic restoration and follow an equivalent design workflow. In the design workflow the primary predicate and subject devices use the same scanners and software to design the restoration.
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 both performing appropriate performance testing on the ceramic component of the two-piece abutment. The titanium abutment materials for both the subject devices and primary predicate is a Titanium Alloy (ASTM 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.
Substantial equivalence of the subject device and primary predicate 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 device in K193084.
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 and titanium nitride coating. The anodization and coating processes are 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.
In support of substantial equivalence in terms of mechanical performance, dynamic compression-bending testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants was performed. Dynamic testing was performed on worst-case subject device constructs. The results from the worst-case construct bench testing demonstrated fatigue performance of the subject device that exceeds its indication and is supported by bench testing previously cleared in K173706 and K222457.
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 K193084. Furthermore, biocompatibility testing per the FDA Guidance Document for Use of Standard ISO 10993-1, "Biological evaluation of medical devices – Part1: Evaluation
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and testing within a risk management process" was performed.
The inclusion of the 3Shape software (K151455) was validated with performance testing per the FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices.
Overall, the subject device has the following similarities to the predicate devices:
- A similar intended use
- Incorporates the same basic design
- · Incorporates the same or very similar materials,
- · Follows the equivalent design and manufacturing workflows,
- · Incorporates the same abutment surface treatment and packaging,
- Has similar fatigue limits
CONCLUSION
The subject device and the predicate devices all incorporate the same materials, basic design and intended use. The subject device and the predicate devices are for substantial equivalence of surface treatment and patient usage, and are provided non-sterile. The subject device and the primary predicate follow the same design and manufacturing CAD/CAM workflows.
The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.
§ 872.3630 Endosseous dental implant abutment.
(a)
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.(b)
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.)