(124 days)
No
The summary describes a digital workflow involving CAD/CAM software for designing dental prosthetics, but there is no mention of AI or ML being used in the design process or any other part of the device's function. The software is described as having "limitations" to prevent malfunctioning, which is a rule-based approach, not indicative of AI/ML.
No
The device is a prosthetic component intended to aid in prosthetic rehabilitation by supporting a dental restoration to restore chewing function. It does not directly treat or cure a disease but rather replaces a missing body part and restores functionality.
No
The device, ASC Solution Abutments and SI-BASE Abutments, is described as premanufactured prosthetic components used for prosthetic rehabilitation, supporting dental restorations and restoring chewing function. Its purpose is to interface between an endosseous implant and a restoration, not to diagnose a medical condition.
No
The device description clearly states the device includes physical components (titanium alloy abutments, mesostructure restoration made of zirconia) and is part of a larger digital workflow that includes hardware like scanners and milling machines. While software is used in the design process, the device itself is a physical medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "premanufactured prosthetic component directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation." This describes a device used in vivo (within the body) for structural support and restoration of function, not for testing biological samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details the physical components (titanium base, mesostructure), materials (titanium alloy, zirconia), and how they are used to support a dental restoration and restore chewing function. This aligns with a prosthetic device, not a diagnostic test.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information for the diagnosis, monitoring, or treatment of a disease or condition based on such analysis.
- Workflow: The described workflow involves scanning, CAD/CAM design and milling, and placement of the prosthetic component. This is a typical workflow for dental prosthetics, not IVD testing.
In summary, the device is a dental prosthetic component used for restoring function after dental implant placement, which falls under the category of medical devices used in vivo, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
NHA, PNP
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. Two-piece 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Maxillary and mandibular lateral and central incisors
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 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.
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.
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" was performed.
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.
K173706, K222457, K163634, K163060, K053478, K070905, K130991, K130436, K151455
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
§ 872.3630 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.)
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Southern Implants (Pty) Ltd Colin Saffy Head of Regulatory Affairs and Ouality 1 Albert Road Irene, Gauteng 0062 SOUTH AFRICA
Re: K230873
Trade/Device Name: Angulated Screw Channel (ASC) Solution Abutments and SI-BASE Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA. PNP Dated: June 29, 2023 Received: June 30, 2023
Dear Colin Saffy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K230873
Device Name
Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments
Indications for Use (Describe)
The Angulated Screw Channel (ASC) Solution Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The ASC Solution Abutments and SI-BASE Abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAD software, ceramic material, milling machine and associated tooling and accessories.
The intended use for the engaging ASC Solution Abutments and SI-BASE Abutments used with the Ø3.0 External-Hex implants, Ø3.3 PROVATA implants and Ø3.5/Ø4.0 Deep Conical implants are intended for use with a straight mesostructure component.
The intended use for the engaging ASC Solution Abutments and SI-BASE Abutments used with the Ø3.4 and Ø4.0 External-Hex implants. PROVATA implants and 03.5 and 04.3 TRI-NEX implants is limited to replacement of maxillary and mandibular lateral and central incisors.
The ASC Solution Abutments and SI-BASE Abutments for Compact Conical Abutments are intended for use on straight Compact Conical Abutments with a straight mesostructure component.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------- |
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3
510(k) Summary K230873
Angulated Screw Channel (ASC) Solution and SI-BASE Abutments
Southern Implants (Pty) Ltd
July 31, 2023
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Southern Implants (Pty) Ltd
1 Albert Road
Irene, Gauteng, 0062 South Africa
Telephone +27 12 667 1046
Fax +27 12 667 1029 |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Colin A. Saffy
Head of Regulatory Affairs and Quality |
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary name
Common name
Classification name Classification regulation Primary Product Code Secondary Product Code
Classification Panel Reviewing Branch
Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments Dental Abutment
Endosseous Dental Implant Abutment 21 CFR 872.3630, Class II NHA PNP
Email: colin.s(@southernimplants.com
Dental Products Panel Dental Devices Branch
PREDICATE DEVICE INFORMATION
The primary predicate device is K193084 The reference predicate devices are K173706, K222457, K163634, K163060, K053478, K070905, K130991, K130436, and K151455.
4
INDICATIONS FOR USE STATEMENT
The Angulated Screw Channel (ASC) Solution Abutments and SI-BASE Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The ASC Solution Abutments and SI-BASE Abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAD software. CAM software, ceramic material. milling machine and associated tooling and accessories.
The intended use for the engaging ASC Solution Abutments and SI-BASE Abutments used with the Ø3.0 External-Hex implants, 03.3 PROVATA implants and 03.5/04.0 Deep Conical implants are intended for use with a straight mesostructure component.
The intended use for the engaging ASC Solution Abutments and SI-BASE Abutments used with the 03.4 and Ø4.0 External-Hex implants , PROVATA implants and Ø3.5 and Ø4.3 TRI-NEX implants is limited to replacement of maxillary and mandibular lateral and central incisors.
The ASC Solution Abutments and SI-BASE Abutments for Compact Conical Abutments are intended for use on straight Compact Conical Abutments with a straight mesostructure component.
SUBJECT DEVICE DESCRIPTION
This submission includes two major components which make up the ASC Solution and SI-BASE Abutments - The ASC Solution and SI-BASE Abutment Base and the mesostructure restoration. Twopiece and three-piece abutments models are included. Two-piece abutments consist of the ti-base abutment and mesostructure. Three-piece abutments consist of the ti-base abutment, mesostructure, and compatible compact conical abutments.
The ASC Solution and SI-BASE Abutments are standard premanufactured titanium alloy abutments for supporting a dental restoration and mesostructure. The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The ASC Solution and SI-BASE Abutments then serve as the interface between the endosseous implant and the zirconia restoration. The abutments are designed to support the restoration on an endosseous implant in order to restore chewing function for the patient.
The mesostructured restoration is a CAD/CAM designed prosthesis milled out of zirconia, which is designed to fit the abutment base in order to restore chewing function for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case-by-case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration.
The ASC Solution and SI-BASE Abutments are compatible with the Southern Implants' Deep Conical, External Hex, Provata and Tri-Nex implants and screws. The abutments are manufactured from Titanium alloy conforming to ASTM F136 and are color coded by Titanium nitride coating (ASC Solution Abutments) or yellow anodizing (SI-BASE Abutments). The TiN coating and anodization processes are the same as used for previously cleared anodized titanium alloy devices in K163634. The Mesostructure restoration is to be manufactured from Zirconia - Sage Max NexxZr which has been previously cleared for use in K130991.
The digital workflow includes the following products (not subject devices to this submission):
- Ceramic material: Sage Max NexxZr Zirconia Restorative material (K130991) ●
- Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436) .
5
- Intra-oral scanner: 3Shape E3 Desktop Scanner
- Abutment design software: 3Shape Abutment Designer Software (K151455)
- Milling machine: Roland DWX51D Milling Unit ●
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments: Biocompatibility testing per the FDA Guidance Document for Use of Standard ISO 10993-1, "Biological evaluation of medical devices - Part1: Evaluation and testing within a risk management process" and ISO 10993-5 "Biological Evaluation of Medical Devices - Part 5: Tests for In-Vitro Cytotoxicity"; validated sterilization instructions per ISO 17665-1 and ISO 17665-2; software validation testing per the FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices; scanning and milling validation; and static and dynamic compression-bending according to ISO 14801. No clinical data was included in this submission.
Software verification and validation testing was provided for the subject abutment design library to demonstrate use with both the 3Shape Abutment Designer Software verification and validation testing were conducted to demonstrate that the restrictions prevent design of the top half component of the multi-piece abutment outside of the allowable design limitations, including screenshots under user verification testing. In addition, the encrypted abutment design library was validated to demonstrate that the established design limitations are locked and cannot be modified within the abutment design library.
MR safety testing as per the recommendations of the FDA Guidance Document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" was performed on the previously cleared devices, K222457, PROVATA Implant System. The ASC Solution Abutments and SI-BASE Abutments were compared to the predicate devices. The ASC Solution and SI-BASE abutments are not worst-case Southern Implants components in terms of material, size or shape and therefore the subject devices can be considered equally MR Safe as the predicate devices.
EQUIVALENCE TO MARKETED DEVICE
Southern Implants (Pty) Ltd submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the substantially equivalent in indications and design principles to the following legally marketed predicate devices:
K 193084, TIB Abutment System, Southern Implants (Pty) Ltd. K173706, Piccolo Implants and Accessories, Southern Implants (Pty) Ltd. K222457, PROVATA Implant System, Southern Implants (Pty) Ltd. K 163634, External Hex Implants and Accessories, Southern Implants (Pty) Ltd. K163060, Deep Conical (DC) Implants and Accessories, Southern Implants (Pty) Ltd. K053478, Endosseous Dental Implant System, Northern Implants (Pty) Ltd. K070905, Endosseous Dental Implant System, Southern Implants (Pty) Ltd. K130991, Zirconia restorative material, SageMaxx NexxZr K130436, Multilink Hybrid Abutment Cement, Ivoclar Vivadent K151455, 3Shape Abutment Designer Software, 3Shape A/S
The primary predicate device is K193084.
The reference predicate devices are K053478, K070905, K163060, K163634, K22457 K130991, K130436, and K151455.
A comparison of the technological characteristics of the subject device and the predicate devices is provided in the following table:
6
| Subject Device | Primary Predicate Device | Reference Device | Reference Device | |
|---|---|---|---|---|
| Comparison | Angulated Screw Channel (ASC) | |||
| Abutment System and SI-BASE | ||||
| Abutment System | ||||
| Southern Implants (Pty) Ltd | ||||
| (External Hex ASC Abutments) | K193084 | |||
| TIB Abutment System | ||||
| Southern Implants (Pty) Ltd | K173706 | |||
| Piccolo Implants and Accessories | ||||
| Southern Implants (Pty) Ltd | K163634 | |||
| External Hex Implants | ||||
| Southern Implants (Pty) Ltd | ||||
| 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 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 is limited to | ||||
| replacement of maxillary and | ||||
| mandibular lateral and central incisors. | 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 consists | ||||
| 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 Piccolo Implants and Accessories are | |||
| intended for both one- and two-stage surgical | ||||
| procedures in the following situations and with the | ||||
| following clinical protocols: | ||||
| · replacing maxillary lateral incisors and | ||||
| mandibular incisors, | ||||
| · immediate placement in extraction sites and in | ||||
| situations with a partially or completely healed | ||||
| alveolar ridge, | ||||
| · immediate loading when good primary stability | ||||
| with appropriate occlusal loading is achieved, | ||||
| except in soft bone (type IV) where implant | ||||
| stability may be difficult to obtain. | Southern Implants' External Hex Implants | |||
| are 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. Southern Implants' External Hex | ||||
| Implants are intended for immediate | ||||
| function when good primary stability with | ||||
| appropriate occlusal loading is achieved. | ||||
| Product Code | NHA, PNP | NHA, PNP | DZE, NHA | DZE, NHA |
| Reason for | ||||
| Predicate/Reference | n/a | Abutment (general design and functioning) | ||
| Software Compatibility | ||||
| Abutment Connection Type and Size | Ø3.0 External Hex Abutment Connection Type | |||
| and Size | ||||
| Abutment Surface | External Hex Abutment Connection Type | |||
| and Size | ||||
| Abutment Post Height | ||||
| Abutment Types | External Hex Angulated Screw | |||
| Channels | ||||
| External Hex SI-BASE Abutments | External Hex TiBase Abutments | Piccolo Abutments | Straight titanium abutments: | |
| Titanium cylinders | ||||
| Anatomic abutments | ||||
| Prothesis Attachment | Cement-retained | |||
| Screw-retained | Cement-retained | |||
| Screw-retained | Cement-retained | |||
| Screw-retained | Cement-retained | |||
| Screw-retained | ||||
| Restoration | Single-unit | Single-unit | Single-unit | Single-unit |
| Abutment Connection | ||||
| Interface | Southern Implants External Hex | Southern Implants External Hex | Southern Implants External Hex | Southern Implants External Hex |
| Abutment Connection | ||||
| Interface Diameters | Ø3.00 to Ø4.07 | Ø3.43 to Ø4.07 | 03.00 | Ø3.43 to Ø4.07 |
| Abutment Restorative | ||||
| Platform Diameter | Ø4.00 to Ø4.60 | Ø4.30 to Ø5.10 | 03.5 | Ø3.40 to Ø4.05 |
| Collar/Gingival | ||||
| Height | 1.5mm | 0.6, 1.5 or 3mm | 0.6, 0.75 or 1 mm | 1mm to 5mm |
| Abutment Post | ||||
| Height | Minimum 4.5mm | Minimum 4.5mm | Minimum 4mm | n/a |
| Abutment Angulation | 0° | 0° | 0° | 0° |
| Abutment Material | Titanium Grade 5 Alloy (ASTM F136) | Titanium Grade 5 Alloy (ASTM F136) | Titanium Grade 5 Alloy (ASTM F136) or | |
| Titanium Grade 4 (ASTM F67) or Gold Alloy | Titanium Grade 5 Alloy (ASTM F136) or | |||
| Titanium Grade 4 (ASTM F67) or Gold | ||||
| Alloy | ||||
| Abutment Surface | Machined | Machined | Machined | Machined |
| Knurled (grooved) | ||||
| Titanium nitride coated | Knurled (grooved) | |||
| Anodized | Knurled (grooved) | |||
| Titanium nitride coated | Knurled (grooved) and smooth | |||
| Titanium nitride coated | ||||
| Restoration Material | Zirconia - Sage Maxx NexxZr | |||
| (K130991) | Zirconia - Sage Maxx NexxZr (K130991) | n/a | n/a | |
| Maximum | ||||
| Restoration 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 Design | ||||
| Workflow | 3Shape E3 Desktop Scanner (3Shape | |||
| A/S) | ||||
| 3Shape Abutment Designer Software | 3Shape E3 Desktop Scanner (3Shape A/S) | |||
| 3Shape Abutment Designer Software | n/a | n/a | ||
| CAD/CAM | ||||
| Manufacturing | ||||
| Workflow | WorkNC CAM software, Roland | |||
| DWX51D milling unit | WorkNC CAM software, Roland | |||
| DWX51D milling unit | n/a | n/a | ||
| How Provided | ||||
| Sterility | Non-sterile | Non-sterile | Sterile: Titanium Abutments | |
| Non-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-BASE | ||||
| Abutment System | ||||
| Southern Implants (Pty) Ltd | ||||
| (Internal Connection ASC | ||||
| Abutments) | K193084 | |||
| TIB Abutment System | ||||
| Southern Implants (Pty) Ltd | K222457 | |||
| PROVATA Implant System | ||||
| Southern Implants (Pty) Ltd | K163634 | |||
| External Hex Implants | ||||
| Southern Implants (Pty) Ltd | ||||
| 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 Ø3.3 | ||||
| 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 | ||||
| PROVATA implants and Ø3.5 and | ||||
| Ø4.3 TRI-NEX implants is limited to | ||||
| replacement of maxillary and | ||||
| mandibular lateral and central incisors. | 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 consists | ||||
| 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 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. | ||||
| 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. | Southern Implants' External Hex | |||
| Implants are 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. Southern Implants' | ||||
| External Hex Implants are intended for | ||||
| immediate function when good primary | ||||
| stability with appropriate occlusal | ||||
| loading is achieved. | ||||
| Product Code | NHA, PNP | NHA, PNP | NHA, PNP | DZE, NHA |
| Reason for | ||||
| Predicate/Reference | n/a | Abutment (general design and functioning) | ||
| Software Compatibility | ||||
| Abutment Connection Type and Size | Internal Hex Abutment Connection Type | |||
| and Size | Abutment material | |||
| Surface treatment | ||||
| Packaging methods | ||||
| Abutment Types | All Southern Implants Internal Hex | |||
| Angulated Screw Channel Abutments | ||||
| All Southern Implants Internal Hex SI- | ||||
| BASE Abutments | All Southern Implants Internal Hex TiBase | |||
| Abutments | Narrow PROVATA TiBase Abutment | Compact Conical Abutments | ||
| Prothesis Attachment | Cement-retained | |||
| Screw-retained | Cement-retained | |||
| Screw-retained | Cement-retained | |||
| Screw-retained | Screw-retained | |||
| Restoration | Single-unit | Single-unit | Single-unit | Multi-unit |
| Abutment Connection | ||||
| Interface | Southern Implants Internal Hex | |||
| Connections | Southern Implants Internal Hex | |||
| Connections | Southern Implants Internal Hex | |||
| Connections | Southern Implants External Hex | |||
| Abutment Connection | ||||
| Interface 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 Restorative | ||||
| Platform Diameter | Ø4.00 to Ø4.60 | Ø4.30 to Ø5.00 | Ø3.85 | Ø4.8 and Ø6.0 |
| Collar/Gingival | ||||
| Height | 1.5mm | 0.6 to 3mm | 1.5mm or 3mm | 1.58, 2, 3, 4, and 5.5mm |
| Abutment Post | ||||
| Height | 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 | Machined | |||
| Knurled (grooved) | ||||
| Titanium nitride coated | ||||
| Anodized | Machined | |||
| Knurled (grooved) | ||||
| Anodized | Machined | |||
| Knurled (grooved) | ||||
| Anodized | Machined | |||
| Titanium nitride coated | ||||
| Restoration Material | Zirconia - Sage Maxx NexxZr | |||
| (K130991) | Zirconia - Sage Maxx NexxZr (K130991) | Zirconia - Sage Maxx NexxZr | ||
| (K130991) | n/a | |||
| Maximum | ||||
| Restoration 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 Design | ||||
| Workflow | 3Shape E3 Desktop Scanner (3Shape | |||
| A/S) | ||||
| 3 Shape Abutment Designer Software | 3Shape E3 Desktop Scanner (3Shape A/S) | |||
| 3Shape Abutment Designer Software | 3Shape E3 Desktop Scanner (3Shape | |||
| A/S) | ||||
| 3Shape Abutment Designer Software | n/a | |||
| CAD/CAM | ||||
| Manufacturing | ||||
| Workflow | WorkNC CAM software, Roland | |||
| DWX51D milling unit | WorkNC CAM software, Roland | |||
| DWX51D milling unit | WorkNC CAM software. Roland | |||
| DWX51D 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-BASE | ||||
| Abutment System | ||||
| Southern Implants (Pty) Ltd | ||||
| (Internal Connection ASC | ||||
| Abutments) | K053478/K070905 | |||
| Endosseous Implant and Accessories | ||||
| Northern Implants (Pty) Ltd/ Southern | ||||
| Implants (Pty) Ltd | K193084 | |||
| TIB Abutment System | ||||
| Southern Implants (Pty) Ltd | K163634 | |||
| External Hex Implants | ||||
| Southern Implants (Pty) Ltd | ||||
| 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 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. | The NSI Implant System is intended to | |||
| be implanted in the upper or lower jaw | ||||
| arches to provide support for fixed or | ||||
| removable dental prostheses in a single | ||||
| tooth, partially edentulous protheses, or | ||||
| full arch protheses. It further adds the | ||||
| option for immediate loading on single | ||||
| and splinted multiple unit restorations | ||||
| when good primary stability is achieved | ||||
| and with appropriate occlusal loading, to | ||||
| restore chewing function. | 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 | ||||
| consists 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. | Southern Implants' External Hex | |||
| Implants are 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. Southern Implants' | ||||
| External Hex Implants are intended for | ||||
| immediate function when good primary | ||||
| stability with appropriate occlusal | ||||
| loading is achieved. | ||||
| Product Code | NHA, PNP | DZE | NHA, PNP | DZE, NHA |
| Reason for | ||||
| Predicate/Reference | n/a | Abutment (general design and | ||
| functioning) | ||||
| Abutment Connection Type and Size | ||||
| Abutment material | Software Compatibility | |||
| Sterility | Abutment material | |||
| Surface treatment | ||||
| Packaging methods | ||||
| Abutment Type | Angulated Screw Channel Compact | |||
| Conical Abutments | ||||
| SI-BASE Compact Conical | ||||
| Abutments | Titanium Cylinders for Compact Conical | |||
| Abutments | ||||
| Compact Conical Abutments | All non-engaging TIB Abutments | Compact Conical Abutments | ||
| Prosthesis Attachment | Cement-retained | |||
| Screw-retained | Cement-retained | |||
| Screw-retained | Cement-retained | |||
| Screw-retained | Screw-retained |
Table of Substantial Equivalence – External Hex ASC Solution and SI-BASE Abutments
7
8
Table of Substantial Equivalence – Internal Connection ASC Solution and SI-BASE Abutments
9
10
Table of Substantial Equivalence – Compact Conical ASC Solution Abutments and SI-BASE Abutments
11
| Restoration | Multi-unit | Multi-unit | Single-unit | Multi-unit | ||
|---|---|---|---|---|---|---|
| Abutment | ||||||
| Connection Interface | Ø4.8 Compact Conical | |||||
| Ø6.0 Compact Conical | Ø4.8 Compact Conical | |||||
| Ø6.0 Compact Conical | All Southern Implants Connection Types | External Hex (Ø3.0, 3.43, 4.05, 5.0 and | ||||
| 6.0mm) | ||||||
| Abutment | ||||||
| Restorative Platform | ||||||
| Diameter | Ø5.20 and Ø6.40 | Ø5.20 and Ø6.40 | Varying | Ø4.8 and Ø6.0 | ||
| Collar/Gingival | ||||||
| Height | 1mm | 1mm | 0.6, 1.5 or 3mm | 1.58, 2, 3, 4, and 5.5mm | ||
| Abutment Post | ||||||
| Height | Minimum 4.5mm | n/a | Minimum 4.5mm | n/a | ||
| Abutment | ||||||
| Angulation | 0° | 0° | 0° | 0° | ||
| Abutment Material | Titanium Grade 5 Alloy (ASTM | |||||
| F136) | Titanium Grade 3 (ASTM F67) | Titanium Grade 5 Alloy (ASTM F136) | Titanium Grade 5 Alloy (ASTM F136) | |||
| Abutment Surface | Machined | |||||
| Knurled (grooved) | ||||||
| Titanium nitride coated | ||||||
| Anodized | Machined | |||||
| Knurled (grooved) | Machined | |||||
| Knurled (grooved) | ||||||
| Anodized | Machined | |||||
| Knurled (grooved) | ||||||
| Titanium nitride coated | ||||||
| Restoration Material | Zirconia - Sage Maxx NexxZr | |||||
| (K130991) | n/a | Zirconia - Sage Maxx NexxZr (K130991) | n/a | |||
| Maximum | ||||||
| Restoration Angle | 0° | 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 | M1.4 | M1.4 | Varying | M1.4 | ||
| CAD/CAM Design | ||||||
| Workflow | 3Shape E3 Desktop Scanner (3Shape | |||||
| A/S) | ||||||
| 3Shape Abutment Designer Software | n/a | 3Shape E3 Desktop Scanner (3Shape | ||||
| A/S) | ||||||
| 3Shape Abutment Designer Software | n/a | |||||
| CAD/CAM | ||||||
| Manufacturing | ||||||
| Workflow | WorkNC CAM software, Roland | |||||
| DWX51D milling unit | n/a | WorkNC CAM software, Roland | ||||
| DWX51D 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 |
12
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
13
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.