(203 days)
No
The summary describes a dental implant system and its components, including abutments and the integration with digital dentistry workflows (CAD/CAM). While it mentions software for design (3Shape Abutment Designer), there is no indication or mention of AI or ML being used in the design, manufacturing, or function of the device itself or the associated software. The software validation focuses on design limitations, not AI/ML capabilities.
Yes
The device, a dental implant system, is intended to provide a means for prosthetic attachment of crowns, bridges, or overdentures, and to restore chewing function. These actions are aimed at treating a medical condition (edentulism) and improving a body function, which falls under the definition of a therapeutic device.
No
Explanation: The device, the Provata Implant System, is intended for surgical placement and prosthetic attachment, functioning as an implant and related components. Its purpose is to provide support for crowns, bridges, or overdentures to restore chewing function, not to diagnose medical conditions or diseases.
No
The device description clearly details physical components such as dental implants, abutments, screws, and healing abutments made from materials like titanium and PEEK. While software is mentioned for designing some components (3Shape Abutment Designer Software), the core device is hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical placement in the jaw to support dental prosthetics (crowns, bridges, overdentures). This is a surgical and prosthetic device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details physical components like implants, abutments, screws, and materials used in their construction. It also mentions software for designing prosthetics, but this software is for designing a physical device, not for analyzing biological samples.
- Performance Studies: The performance studies focus on mechanical testing (fatigue, compression-bending), biocompatibility, sterilization, and software validation related to the design of the prosthetic components. There are no studies related to analyzing biological samples or providing diagnostic information.
The device is a dental implant system and associated prosthetic components, which falls under the category of medical devices used for surgical and restorative purposes.
N/A
Intended Use / Indications for Use
Indications for Use for the Provata Implants:
The Provata Implant System is intended for surgical placement in the upper or lower jav 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 Ø3.30 Provata implants is limited to replacement of maxillary and mandibular lateral incisors. The 12° angled Co-Axis Provata Implants are intended to only be used with straight abutments.
Indications for Use for the TIB 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, CAM software, ceramic material, milling machine and associated tooling and accessories.
Indications for Use for the Conventional Abutments and Prosthetic Screws:
The Conventional Abutments and Prosthetic Screws are premanufactured prosthetic components directly connected to endosseous dental implants and intended for use in fully edentulous maxilla and/or maxilla and/or mandible to provide support for crowns, bridges or overdentures.
Indications for Use for the PEEK Temporary Abutments:
The Southern Implants PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
Indications for Use for the Temporary Titanium Abutments:
The Southern Implants Temporary Titanium Abutments are prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
Product codes
DZE, NHA, PNP
Device Description
This submission includes fully threaded root-form dental implants with an internal hexagon interface and mating abutments. The implants are provided in two diameters: Ø3.30 and Ø4.07 mm. The Ø3.30 implants are provided in two designs: Straight and Co-Axis (prosthetic platform inclined 12° from orthogonal to the long axis of the implant). Both the Straight and Co-Axis versions are available in fully roughened and 3 mm machined coronal section configurations. The Ø3.30 Straight and Co-Axis implants are each provided in in one prosthetic diameter (2.90 mm), and in overall lengths of 8.5, 10, 11.5, 13, 15, 18 mm. The Co-Axis implants are to be used with straight abutments only.
The Ø4.07 implants subject to this submission are provided in length 6.4mm and as Straight (0°) implants only. The Ø4.07 implants are provided with a 3.575 mm prosthetic diameter and are available in fully roughened and 2 mm machined coronal section configurations.
This submission also includes: a Cover Screw (one design/size); Healing Abutments in two diameters (3.5 and 4.5 mm) each in three gingival heights (3, 4, and 6 mm); Titanium Cylinder Abutments for temporary restorations in one size and two designs (engaging and non-engaging); Passive Abutments with a plastic burn-out component, in one size and two designs (engaging and non-engaging); PEEK Abutments for temporary restorations in one size and two designs (engaging and non-engaging); Compact Conical Abutments in straight (0°) and 20°, angled design for multi-unit restorations: Narrow TIB Abutment Bases (engaging): and abutment screws.
Passive Abutments are UCLA castable abutments which interface with a plastic, burn-out sleeve used to fabricate a prosthesis that is bonded directly to the top of the abutment, limited to a straight (0°) restoration.
The Narrow and Compact Conical TIB Abutment bases are two-piece abutment designs, consisting standard premanufactured titanium alloy abutments for supporting a hybrid/crown dental restoration and mesostructure (SageMaxx Zirconia) bonded with cement (Ivoclar Vivadent Multilink Hybrid cement). The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The TIB abutment base then serves as the interface between the endosseous implant and the Zirconia restoration. The TIB Abutment Base is designed to support the restoration on an endosseous implant in order to restore chewing function for the patient. The mesostructured restoration is a CAD/CAM designed prosthesis milled out of Zirconia (SageMaxx Zirconia), which is designed to fit the abutment base in order to restore chewing function for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case-by-case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration and a maximum allowable angulation of 20° for the mesostructured component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility evaluations according to ISO 10993-1 (referenced from K180465, K163634, K193084 and K191250); engineering analysis; dimensional analysis; sterilization according to ISO 11137-1, ISO 11137-2, ISO 17665-1, ISO TS 17665-2; bacterial endotoxin according to USP 39-NF 34; sterile barrier shelf life (referenced from K180465, K163634 and K191250, updated by extension of sterile barrier shelf life validation); short implant comparison in terms of surface area, the bone-to-implant contact and the pull-out strength; static and dynamic compression-bending to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants, MR safety testing as per the recommendations of the FDA Guidance Document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" (ASTM F2503, ASTM F2052, ASTM F2182, ASTM F2182, ASTM F2119), software validation testing per the FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices (referenced from K193084); and scanning and milling validation (referenced from K193084). No clinical data were included in this submission.
Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the 3Shape Abutment Designer Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the top half component of the two-piece abutment outside of the allowable design limitations, including screenshots under user verification testing. In addition, the encrypted abutment design library was validated to demonstrate that the established design limitations are locked and cannot be modified within the abutment design library.
In support of substantial equivalence of the Ø3.30 implants in terms of mechanical performance, dynamic compression-bending testing was performed according to ISO 14801. Dynamic testing was performed on worstcase subject device constructs. The results from the testing demonstrated fatigue performance of the subject device that exceeds its indication.
To demonstrate that the subject device 6 mm length Ø4.0 implants are substantially equivalent to a predicate short length implant (cleared in K163634) a report detailing an analysis of the comparative surface area, the comparative bone-to-implant contact and the comparative pull-out strength is provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K163634, K180465, K191250, K193084, K151455, K130991, K130436
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Southern Implants (pty) Ltd Leith Cumming Acting Head of Regulatory Affairs and Quality 1 Albert Rd. Irene, Gauteng 0062 SOUTH AFRICA
Re: K222457
Trade/Device Name: Provata Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA, PNP Dated: February 1, 2023 Received: February 2, 2023
Dear Leith Cumming:
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (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
Indications for Use
510(k) Number (if known) K222457
Device Name Provata Implant System
Indications for Use for the Provata Implants:
The Provata Implant System is intended for surgical placement in the upper or lower jav 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 Ø3.30 Provata implants is limited to replacement of maxillary and mandibular lateral incisors. The 12° angled Co-Axis Provata Implants are intended to only be used with straight abutments.
Indications for Use for the TIB 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, CAM software, ceramic material, milling machine and associated tooling and accessories.
Indications for Use for the Conventional Abutments and Prosthetic Screws:
The Conventional Abutments and Prosthetic Screws are premanufactured prosthetic components directly connected to endosseous dental implants and intended for use in fully edentulous maxilla and/or maxilla and/or mandible to provide support for crowns, bridges or overdentures.
Indications for Use for the PEEK Temporary Abutments:
The Southern Implants PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
Indications for Use for the Temporary Titanium Abutments:
The Southern Implants Temporary Titanium Abutments are prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) Summary
Provata Implant System
Southern Implants (Pty) Ltd
March 6, 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 | Leith C. Cumming
Acting Head of Regulatory Affairs and Quality
Email: leith.c@southernimplants.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Provata Implant System |
|---|---|
| Common Name | Dental implant |
| Classification Name | Endosseous dental implant |
| Classification Regulation | 21 CFR 872.3640, Class II |
| Product Code | DZE (Primary) |
| NHA, PNP (Secondary) | |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
PREDICATE DEVICE INFORMATION
Primary predicate devices:
K 180282, MIS Internal Hex Dental Implant System, MIS Implants Technologies Ltd.
Reference devices:
K163634, External Hex Implants, Southern Implants (Pty) Ltd. K180465, Provata Implant System, Southern Implants (Pty) Ltd. K191250, Southern Implants PEEK abutments, Southern Implants (Pty) Ltd. K193084, TIB Abutment System, Southern Implants (Pty) Ltd. K151455. 3Shape Abutment Designer K130991, SageMax NexxZr Zirconia K130436, Ivoclar Vivadent Multilink Hybrid abutment cement
INDICATIONS FOR USE STATEMENT
Indications for Use for the Provata Implants:
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 Ø3.30 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.
5
Indications for Use for the TIB 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.
Indications for Use for the Conventional Abutments and Prosthetic Screws:
The Conventional Abutments and Prosthetic Screws are premanufactured prosthetic components directly connected to endosseous dental implants and intended for use in fully edentulous or partially edentulous maxilla and/or mandible to provide support for crowns, bridges or overdentures.
Indications for Use for the PEEK Temporary Abutments:
The Southern Implants PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
Indications for Use for the Temporary Titanium Abutments:
The Southern Implants Temporary Titanium Abutments are prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
SUBJECT DEVICE DESCRIPTION
This submission includes fully threaded root-form dental implants with an internal hexagon interface and mating abutments. The implants are provided in two diameters: Ø3.30 and Ø4.07 mm. The Ø3.30 implants are provided in two designs: Straight and Co-Axis (prosthetic platform inclined 12° from orthogonal to the long axis of the implant). Both the Straight and Co-Axis versions are available in fully roughened and 3 mm machined coronal section configurations. The Ø3.30 Straight and Co-Axis implants are each provided in in one prosthetic diameter (2.90 mm), and in overall lengths of 8.5, 10, 11.5, 13, 15, 18 mm. The Co-Axis implants are to be used with straight abutments only.
The Ø4.07 implants subject to this submission are provided in length 6.4mm and as Straight (0°) implants only. The Ø4.07 implants are provided with a 3.575 mm prosthetic diameter and are available in fully roughened and 2 mm machined coronal section configurations.
This submission also includes: a Cover Screw (one design/size); Healing Abutments in two diameters (3.5 and 4.5 mm) each in three gingival heights (3, 4, and 6 mm); Titanium Cylinder Abutments for temporary restorations in one size and two designs (engaging and non-engaging); Passive Abutments with a plastic burn-out component, in one size and two designs (engaging and non-engaging); PEEK Abutments for temporary restorations in one size and two designs (engaging and non-engaging); Compact Conical Abutments in straight (0°) and 20°, angled design for multi-unit restorations: Narrow TIB Abutment Bases (engaging): and abutment screws.
Passive Abutments are UCLA castable abutments which interface with a plastic, burn-out sleeve used to fabricate a prosthesis that is bonded directly to the top of the abutment, limited to a straight (0°) restoration.
The Narrow and Compact Conical TIB Abutment bases are two-piece abutment designs, consisting standard premanufactured titanium alloy abutments for supporting a hybrid/crown dental restoration and mesostructure (SageMaxx Zirconia) bonded with cement (Ivoclar Vivadent Multilink Hybrid cement). The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The TIB abutment base then serves as the interface between the endosseous implant and the Zirconia restoration. The TIB Abutment Base is designed to support the restoration on an endosseous implant in order to restore chewing function for the patient. The mesostructured restoration is a CAD/CAM designed prosthesis milled out of Zirconia (SageMaxx Zirconia), which is designed to fit the abutment base in order to restore chewing function for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case-by-case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration and a maximum allowable angulation of 20° for the mesostructured component.
6
All Provata implants are manufactured from unalloyed titanium conforming to ASTM F67, with a smooth machined collar (0.6mm or extended machined surface of 2 or 3 mm). The remainder of the entire endosseous threaded surface) is grit-blasted. The subject device implant material and surface is identical to the implants cleared in K163634 and K180465. The Cover Screw and Healing Abutments are manufactured from unalloyed titanium conforming to ASTM F67. The remaining Abutments are manufactured from titanium alloy conforming to ASTM F136. The PEEK Abutments are manufactured from medical grade white Polyetheretherketone. The abutment screws are manufactured from titanium alloy conforming to ASTM F136. All subject device components are manufactured in the same facilities using the same materials and manufacturing processes as used for the Southern Implants devices previously cleared in K163634, K180465, K193084 and K191250.
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility evaluations according to ISO 10993-1 (referenced from K180465, K163634, K193084 and K191250); engineering analysis; dimensional analysis; sterilization according to ISO 11137-1, ISO 11137-2, ISO 17665-1, ISO TS 17665-2; bacterial endotoxin according to USP 39-NF 34; sterile barrier shelf life (referenced from K180465, K163634 and K191250, updated by extension of sterile barrier shelf life validation); short implant comparison in terms of surface area, the bone-to-implant contact and the pull-out strength; static and dynamic compression-bending to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants, MR safety testing as per the recommendations of the FDA Guidance Document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" (ASTM F2503, ASTM F2052, ASTM F2182, ASTM F2182, ASTM F2119), software validation testing per the FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices (referenced from K193084); and scanning and milling validation (referenced from K193084). No clinical data were included in this submission.
Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the 3Shape Abutment Designer Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the top half component of the two-piece abutment outside of the allowable design limitations, including screenshots under user verification testing. In addition, the encrypted abutment design library was validated to demonstrate that the established design limitations are locked and cannot be modified within the abutment design library.
EQUIVALENCE TO MARKETED DEVICE
Southern Implants (Pty) Ltd submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA 's regulation of medical device is substantially equivalent in indications and design principles to the following legally marketed predicate devices listed above.
For the subject device Ø3.30 Provata implant system, the primary predicate device is K180282. The reference devices are K163634 and K180465 for the Ø3.30 Provata implants and abutments (excluding the PEEK abutments and Narrow TIB Abutment Bases), K191250 for the PEEK abutments, K193084 and K151455 for the Narrow TIB Abutments, and K163634 and K180465 for the 6mm length Ø4.0 Provata implants.
A comparison of the technological characteristics of the subject devices and the predicate devices is provided in the following tables.
7
| | Subject Device | Primary Predicate
Device | Reference Device | Reference Device |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison | Ø3.30 Provata Implant
System
Southern Implants
(Pty) Ltd | K180282
MIS Internal Hex
Dental Implant System
MIS Implants
Technologies Ltd | K180465
Provata Implant
System
Southern Implants
(Pty) Ltd | K163634
External Hex Implants
Southern Implants
(Pty) Ltd |
| Indications for
Use Statement | 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
Ø3.30 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. | MIS dental implant
systems are intended to
be surgically placed in
the bone of the upper or
lower jaw arches to
provide support for
prosthetic devices, such
as artificial teeth, in order
to restore masticatory
function. When a one-
stage surgical procedure
is applied, the implant
may be immediately
loaded when good
primary stability is
achieved and the occlusal
load is appropriate.
Narrow implants
(Ø3.3mm & UNO) are
indicated for use in
surgical and restorative
applications for
placement only in the
mandibular central,
lateral incisor and
maxillary lateral incisor
regions of partially
edentulous jaws, to
provide support for
prosthetic devices such as
artificial teeth.
Mandibular central and
lateral incisors must be
splinted if using two or
more narrow implants
adjacent to one another.
The long MIS (18 & 20
mm) implants can be
used in a tilted manner.
MIS short implants are to
be used only with straight
abutments.
M4 short implants are
indicated for delayed
loading only. | 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. | 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
Intended Use | DZE
Functional and esthetic
rehabilitation
of
the
edentulous maxilla. | DZE
Intended to be surgically
placed in the bone of the
upper or lower jaw arches
for anchoring
or
supporting
tooth
replacement to restore
chewing function. | DZE
Functional and esthetic
rehabilitation
of
the
edentulous maxilla. | DZE
Functional and esthetic
rehabilitation
of
the
edentulous maxilla. |
| Reason for
Predicate/Reference | Not applicable | Implant (general design
and diameter)
Internal hex connection | Implant (general design
and diameter)
Internal hex connection
Indications for Use | Implants (general design,
implant length and
diameter) |
| Item Code | PRO300; MSC-PRO300;
PRO12D300; MSC-
PRO12D300 | MF7-xx330 (xx indicates
implant length) | PRO400; MSC-PRO400;
PRO12D400; MSC-
PRO12D400 | IBNT; MSC-IBNT |
| Implant Design | Fully threaded tapered | Tapered, conical shape, | Fully threaded tapered | Fully threaded tapered |
| | | | | |
| Implant Diameter | 3.30 mm | 3.30 mm | 4.07 mm | 3.25 mm |
| Implant Length | 8.5, 10, 11.5, 13, 15, 18 mm | 10, 11.5, 13, 16 mm | 8.5, 10, 11.5, 13, 15, 18 mm | 8.5, 10, 11.5, 13, 15, 18 mm |
| Platform Angle,
Relative to
orthogonal to
implant long axis | 0° and angled 12°
(inclined) | 0° (straight) | 0° and angled 12°
(inclined) | 0° and angled 12°
(inclined) |
| Implant Platform
Diameter | 3.10 mm for 0° implant,
3.0 mm for 12° implant | Not provided | 3.87 mm | 3.43 mm |
| Implant Prosthetic
Diameter | 2.90 mm | Not provided | 3.575 mm | 3.43 mm |
| Machined Collar | Regular implants: 0.6 mm
MSC implants: 3 mm | None | Regular implants: 0.6 mm
MSC implants: 3 mm | Regular implants: 0.6 mm
MSC implants: 3 mm |
| Implant Interface | Internal Hex | Internal Hex | Internal Hex | External Hex |
| Implant Material | Unalloyed titanium
(ASTM F67) Grade 4,
and UTS ≥ 900MPa
(cold-worked) | Titanium 6Al-4V ELI per
ASTM F136 | Unalloyed titanium
(ASTM F67) Grade 4,
and UTS ≥ 900MPa
(cold-worked) | Unalloyed titanium
(ASTM F67) Grade 4,
and UTS ≥ 900MPa
(cold-worked) |
| Implant Endosseous
Surface | Grit-blasted | Anodized, sand blasted
and acid etched | Grit-blasted | Grit-blasted |
| How Provided | | | | |
| Sterility | Provided sterile | Provided sterile | Provided sterile | Provided sterile |
| Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| Usage | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use |
| Shelf life of
packaging | 10 years | 5 years | 5 years | 5 years |
8
9
| Subject Device | Reference Device | |
|---|---|---|
| Comparison | Conventional Abutments for Ø3.30 Provata | |
| Implant System | K180465 | |
| Southern Implants (Pty) Ltd | Provata Implant System | |
| Southern Implants (Pty) Ltd | ||
| Indications for Use | ||
| Statement | The Conventional Abutments and Prosthetic | |
| Screws are premanufactured prosthetic | ||
| components directly connected to endosseous | ||
| dental implants and intended for use in fully | ||
| edentulous or partially edentulous maxilla and/or | ||
| mandible to provide support for crowns, bridges | ||
| or overdentures. | The 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. | ||
| Product Code | NHA | NHA |
| Intended Use | Functional and esthetic rehabilitation of the | |
| edentulous maxilla. | Functional and esthetic rehabilitation of the | |
| edentulous maxilla. | ||
| Reason for | ||
| Predicate/Reference | Not applicable | General design of Cover Screw, Healing |
| Abutment, Passive Abutment, and Compact | ||
| Conical Abutment | ||
| Indications for Use | ||
| Cover Screw | ||
| Item Code | CS-3M | CS-M |
| Platform diameter | 2.90 mm | 3.575 mm |
| Maximum diameter | 2.94 mm | 3.61 mm |
| Material | Unalloyed titanium (ASTM F67) Grade 4, | |
| anodized | Unalloyed titanium (ASTM F67) Grade 4 | |
| Healing Abutment | ||
| Item Code | HA-3M | HA-M |
| Collar height | 3, 4, 6 mm | 3, 4, 6 mm |
| Collar diameter | 3.4, 4.5 mm | 3.7, 4.5, 5.5 mm |
| Material | Unalloyed titanium (ASTM F67) Grade 4, | |
| anodized | Unalloyed titanium (ASTM F67) Grade 4 | |
| Passive Abutment | ||
| Item Code | PA-3EM-STC; PA-3NM-STC | PA-EM-STC; PA-NM-STC |
| Connection configurations | Engaging and non-engaging; Single-unit and | |
| multi-unit | Engaging and non-engaging; Single-unit and | |
| multi-unit | ||
| Prosthesis attachment | Screw-retained | Screw-retained |
| Collar height | 0.4 mm | 0.4 mm |
| Collar diameter | 3 mm | 3.61 mm |
| Abutment angle | 0° | 0° |
| Abutment material | Titanium alloy (ASTM F136) Grade 5 | Unalloyed titanium (ASTM F67) Grade 4 |
| Abutment screw material | Titanium alloy (ASTM F136) Grade 5 | Titanium alloy (ASTM F136) Grade 5, Or gold |
| alloy | ||
| Compact Conical Abutment | ||
| Item Code | MC-3M; MC-3M-20D | MC-M; MC-M-20D; MC-M-30D |
| Connection configurations | 0°: Non-engaging; Multi-unit | |
| 20°: Engaging; Multi-unit | 0°: Non-engaging; Multi-unit | |
| 20° and 30°: Engaging; Multi-unit | ||
| Prosthesis attachment | Screw-retained | Screw-retained |
| Collar height | 0°: 1, 3, 5 mm | |
| 20°: 1.56 mm – 3.20 mm | 0°: 1, 3, 5 mm | |
| 20°: 1.21 mm - 2.85 mm | ||
| 30°: 0.61 mm - 3.01 mm | ||
| Collar diameter | 4.8 mm | 4.8 mm |
| Abutment angle | 0°, 20° | 0°, 20°, 30° |
| Abutment material | Titanium alloy (ASTM F136) Grade 5, with TiN | |
| coating | Titanium alloy (ASTM F136) Grade 5, with TiN | |
| coating | ||
| Abutment screw material | Titanium alloy (ASTM F136) Grade 5 | Titanium alloy (ASTM F136) Grade 5 |
| How Provided | ||
| Sterility | Provided sterile | |
| Cover Screws | ||
| Healing Abutments | ||
| Compact Conical Abutments | ||
| All abutment screws | ||
| Provided nonsterile | ||
| Passive Abutments | Provided sterile | |
| Cover Screws | ||
| Healing Abutments | ||
| Compact Conical Abutments | ||
| All abutment screws | ||
| Provided nonsterile | ||
| Passive Abutments | ||
| Sterilization | Gamma irradiation | Gamma irradiation |
| Usage | Single-patient, single-use | Single-patient, single-use |
| Shelf life of packaging | 5 years | 5 years |
10
11
| Subject Device | Reference Device | Reference Device | |
|---|---|---|---|
| Comparison | Temporary Titanium Abutments | ||
| for Ø3.30 Provata Implant | |||
| System | |||
| Southern Implants (Pty) Ltd | K180465 | ||
| Provata Implant System | |||
| Southern Implants (Pty) Ltd | K191250 | ||
| Southern Implants PEEK | |||
| abutments | |||
| Southern Implants (Pty) Ltd | |||
| Temporary Titanium Abutment | |||
| Indications for | |||
| Use Statement | The Southern Implants Temporary | ||
| Titanium Abutments are | |||
| premanufactured prosthetic | |||
| components directly connected to | |||
| endosseous dental implants and are | |||
| intended for provisional use up to | |||
| 180 days as an aid in prosthetic | |||
| rehabilitation. | The 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 Southern Implants PEEK | ||
| Abutments are premanufactured | |||
| prosthetic components directly | |||
| connected to endosseous dental | |||
| implants and are intended for | |||
| provisional use up to 180 days as | |||
| an aid in prosthetic rehabilitation. | |||
| Product Code | NHA | NHA | NHA |
| Item Code | TC-3M; TC-3NM | TC-M; TC-NM | PKIP2H; PKIP2NH; PKC-M-2; |
| PKC-NM-2 | |||
| Intended Use | Functional and esthetic | ||
| rehabilitation of the edentulous | |||
| maxilla. | Functional and esthetic | ||
| rehabilitation of the edentulous | |||
| maxilla. | Temporary Abutment | ||
| Reason for | |||
| Predicate/Reference | Not applicable | Titanium Cylinder Abutment | |
| design | Indications for Use | ||
| Connection | |||
| configurations | Engaging and non-engaging; | ||
| Single-unit and multi-unit | Engaging and non-engaging; | ||
| Single-unit and multi-unit | Engaging and non-engaging; | ||
| Single-unit and multi-unit | |||
| Prosthesis | |||
| attachment | Cement-retained | Cement-retained | Cement-retained |
| Collar height | 2 mm | 2 mm | 2 mm |
| Collar diameter | 3.5 mm | 4.0 mm | 3.35, 4.0 mm |
| Abutment angle | 0° | 0° | 0° |
| Implant Connection | Internal Hex | Internal Hex | External Hex; Internal Hex |
| Abutment material | Titanium alloy (ASTM F136) | ||
| Grade 5, anodized | Unalloyed titanium (ASTM F67) | ||
| Grade 4, anodized | Polyetheretherketone (PEEK) | ||
| (white) | |||
| Abutment screw | |||
| material | Titanium alloy (ASTM F136) | ||
| Grade 5 | Titanium alloy (ASTM F136) | ||
| Grade 5, Or gold alloy | Titanium alloy (ASTM F136) | ||
| Grade 5, Or gold alloy | |||
| How Provided | |||
| Sterility | Provided sterile | Provided sterile | Provided sterile |
| Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| Usage | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use |
| Shelf life of | |||
| packaging | 5 years | 5 years | 5 years |
12
| Subject Device | Reference Device | |
|---|---|---|
| Comparison | PEEK Abutments for Ø3.30 Provata Implant | |
| System | ||
| Southern Implants (Pty) Ltd | K191250 | |
| Southern Implants PEEK abutments | ||
| Southern Implants (Pty) Ltd | ||
| PEEK Abutment | ||
| Indications for Use | ||
| Statement | The Southern Implants PEEK Abutments are | |
| premanufactured prosthetic components directly | ||
| connected to endosseous dental implants and are | ||
| intended for provisional use up to 180 days as an | ||
| aid in prosthetic rehabilitation. | The Southern Implants PEEK Abutments are | |
| premanufactured prosthetic components directly | ||
| connected to endosseous dental implants and are | ||
| intended for provisional use up to 180 days as an | ||
| aid in prosthetic rehabilitation. | ||
| Product Code | NHA | NHA |
| Item Code | PKC-3M-2; PKC-3NM-2 | PKIP2H; PKIP2NH; PKC-M-2; PKC-NM-2 |
| Intended Use | Temporary Abutment | Temporary Abutment |
| Reason for | ||
| Predicate/Reference | Not applicable | PEEK abutment (all aspects of device design and |
| Indications for Use) | ||
| Connection configurations | Engaging and non-engaging; Single-unit and | |
| multi-unit | Engaging and non-engaging; Single-unit and | |
| multi-unit | ||
| Prosthesis attachment | Cement-retained | Cement-retained |
| Collar height | 2 mm | 2 mm |
| Collar diameter | 3.50 mm | 3.35, 4 mm |
| Abutment angle | 0° | 0° |
| Implant Connection | Internal Hex | External Hex; Internal Hex |
| Abutment material | Polyetheretherketone (PEEK) (white) | Polyetheretherketone (PEEK) (white) |
| Abutment screw material | Titanium alloy (ASTM F136) Grade 5 | Titanium alloy (ASTM F136) Grade 5, Or gold |
| alloy | ||
| How Provided | ||
| Sterility | Provided sterile | Provided sterile |
| Sterilization | Gamma irradiation | Gamma irradiation |
| Usage | Single-patient, single-use | Single-patient, single-use |
| Shelf life of packaging | 5 years | 5 years |
13
| Subject Device | Reference Device | |
|---|---|---|
| Comparison | Narrow TIB Abutment Bases for Ø3.30 | |
| Provata Implant System | ||
| Southern Implants (Pty) Ltd | K193084 | |
| TIB Abutment System | ||
| Southern Implants (Pty) Ltd | ||
| Narrow TIB Abutment Base | ||
| Indications for Use | ||
| Statement | The TIB Abutments are premanufactured | |
| prosthetic components directly connected to | ||
| endosseous dental implants and are intended for | ||
| use as an aid in prosthetic rehabilitation. The TIB | ||
| abutments consist of two major parts. Specifically, | ||
| the titanium base and mesostructure components | ||
| make up a two-piece abutment. The system | ||
| integrates multiple components of the digital | ||
| dentistry workflow: Scan files from desktop | ||
| scanners, CAD software, CAM software, ceramic | ||
| material, milling machine and associated tooling | ||
| and accessories. | The TIB Abutments are premanufactured | |
| prosthetic components directly connected to | ||
| endosseous dental implants and are intended for | ||
| use as an aid in prosthetic rehabilitation. The TIB | ||
| abutments consist of two major parts. Specifically, | ||
| the titanium base and mesostructure components | ||
| make up a two-piece abutment. The system | ||
| integrates multiple components of the digital | ||
| dentistry workflow: Scan files from desktop | ||
| scanners, CAD software, CAM software, ceramic | ||
| material, milling machine and associated tooling | ||
| and accessories. | ||
| Product Code | NHA, PNP | NHA, PNP |
| Item Code | TIBS-3M-C1.5 | |
| TIBS-3M-C3 | TIB-M-C1.5 | |
| TIB-M-C3 | ||
| Intended Use | Permanent abutment | Permanent abutment |
| Reason for | ||
| Predicate/Reference | Not applicable | Abutment (general design and functioning) |
| Software Compatibility | ||
| Indications for Use | ||
| Abutment design | 2 Piece - Premanufactured titanium abutment, | |
| mounted onto the implant and fixed with a screw. | ||
| SageMaxx Zirconia (K130991) hybrid/crown | ||
| restoration milled and bonded to the titanium | ||
| abutment. | 2 Piece - Premanufactured titanium abutment, | |
| mounted onto the implant and fixed with a screw. | ||
| SageMaxx Zirconia (K130991) hybrid/crown | ||
| restoration milled and bonded to the titanium | ||
| abutment. | ||
| Collar height | 1.5 or 3 mm | 1.5 or 3 mm |
| Maximum abutment angle | 20° | 20° |
| Implant Connection | Internal Hex | Internal Hex |
| Post height | Minimum 4.5 mm | Minimum 4.5 mm |
| Abutment Restorative | ||
| Platform Diameter | 3.85 mm | 4.50 mm |
| Abutment material | Titanium Grade 5 Alloy (ASTM F136) | Titanium Grade 5 Alloy (ASTM F136) |
| Abutment surface | Machined and anodized | Machined and anodized |
| Abutment screw material | Titanium Grade 5 Alloy (ASTM F136) | Titanium Grade 5 Alloy (ASTM F136) |
| Restoration material | Zirconia - Sage Maxx NexxZr (K130991) | Zirconia - Sage Maxx NexxZr (K130991) |
| CAD/CAM Design | 3Shape E3 Desktop Scanner (3Shape A/S) | 3Shape E3 Desktop Scanner (3Shape A/S) |
| Workflow | 3Shape Abutment Designer Software | 3Shape Abutment Designer Software |
| CAD/CAM Manufacturing | ||
| Workflow | WorkNC CAM software, Roland DWX51D | |
| milling unit | WorkNC CAM software, Roland DWX51D | |
| milling unit | ||
| Mechanical Fatigue Testing | Dynamic Fatigue Testing per ISO 14801 | Dynamic Fatigue Testing per ISO 14801 |
| How Provided | ||
| Sterility | Provided non-sterile | Provided non-sterile |
| Usage | Single-patient, single-use | Single-patient, single-use |
14
| Subject Device | Reference Device | Reference Device | |
|---|---|---|---|
| Comparison | 6mm Ø4.0 Provata Implant | ||
| System | |||
| Southern Implants (Pty) Ltd | K163634 | ||
| External Hex Implants | |||
| Southern Implants (Pty) Ltd | K180465 | ||
| Provata Implant System | |||
| Southern Implants (Pty) Ltd | |||
| 6 mm length Ø4.0 Implant | |||
| Indications for | |||
| Use Statement | 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 Ø3.30
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 | 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. | 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. |
| Product Code | DZE | DZE | DZE |
| Intended Use | Functional and esthetic
rehabilitation of the edentulous
maxilla. | Functional and esthetic
rehabilitation of the edentulous
maxilla. | Functional and esthetic
rehabilitation of the edentulous
maxilla. |
| Reason for
Predicate/Reference | Not applicable | Implant Design
Implant Length | Implant (general design and
diameter)
Internal hex connection
Indications for Use |
| Item Code | PRO406; MSC-PRO406 | IBT; MSC-IBT | PRO400; MSC-PRO400; |
| Implant Design | Fully threaded tapered root-form
dental implants | Fully threaded tapered root-form
dental implants | Fully threaded tapered root-form
dental implants |
| Implant Diameter | 4.07 mm | 4.07 mm | 4.07 mm |
| Implant Length | 6.4 mm | 6, 8.5, 10, 11.5, 13, 15, 18 mm | 8.5, 10, 11.5, 13, 15, 18 mm |
| Platform Angle,
Relative to
orthogonal to
implant long axis | 0° | 0° | 0° |
| Implant Platform
Diameter | 3.87 mm | 4.07 mm | 3.87 mm |
| Implant Prosthetic
Diameter | 3.575 mm | 4.07 mm | 3.575 mm |
| Machined Collar | Regular implants: 0.6 mm
MSC implants: 2 mm | Regular implants: 0.6 mm
MSC implants: 3 mm | Regular implants: 0.6 mm
MSC implants: 2 mm |
| Implant Interface | Internal Hex | External Hex | Internal Hex |
| Implant Material | Unalloyed titanium (ASTM F67)
Grade 4, and UTS ≥ 900MPa
(cold-worked) | Unalloyed titanium (ASTM F67)
Grade 4, and UTS ≥ 900MPa
(cold-worked) | Unalloyed titanium (ASTM F67)
Grade 4, and UTS ≥ 900MPa
(cold-worked) |
| Implant
Endosseous Surface | Grit-blasted | Grit-blasted | Grit-blasted |
| How Provided | | | |
| Sterility | Provided sterile | Provided sterile | Provided sterile |
| Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| Usage | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use |
| Shelf life of | 10 years | 5 years | 5 years |
The Indications for Use Statement for the subject device implants is identical to the reference device K180465, with the only difference being the indication of the Ø3.30 Provata implants limited to replacement of maxillary
15
and mandibular lateral and central incisors, and the additional limited use of straight abutments only for the 12° Co-Axis Provata implants. The Indications for Use Statement for the subject device is similar to the primary predicate device K180282 in terms of the limited indication for the narrow implants (Ø3.3mm and UNO implants) for replacement of mandibular central, lateral incisor and maxillary lateral incisor. The subject device thus has an indication for use significantly similar to the predicate devices. Additionally, the subject device Indications for Use statement specifies the intended use of the Narrow TIB Abutment identical to that of predicate K193084.
The primary predicate device K180282 is for substantial equivalence of the subject device Ø3.30 implant designs. The subject device implants have a similar internal hex connection and identical major diameter as implants in K180282, specifically the Narrow Platform MIS SEVEN implants. The subject device implants' indications for use is limited to the central and lateral mandbular and maxillary incisors, whereas the predicate's (K180282) indication for use excludes the maxillary central incisors. The reference device K163634 is for substantial equivalence of the subject device implant diameter, lengths (8.5 mm to 18 mm), platform angle (0° and 12°), material, machined collar, and endosseous surface. The reference device K180465 is for substantial equivalence of the subject device internal connection.
The reference device K180465 also serves as a predicate for substantial equivalence of the subject device Conventional abutment designs. The reference device K163634 is for the substantial equivalence of the subject device abutment-implant prosthetic diameter and surface treatment. The slight difference in Indications for Use statements for the Conventional Abutments and the reference device predicate K180465 does not affect the intended use of the devices, which is to provide support for crowns, bridges and overdentures in the maxilla and mandible. The slight difference in Indications for Use statement for the Conventional Abutments provides a description of the devices to differentiate them as prosthetic components being connected to endosseous dental implants, rather than being the endosseous implant.
The reference device K180465 also serves as a predicate for substantial equivalence of the subject device Temporary Titanium Abutment designs. The reference device K163634 is for the substantial equivalence of the subject device abutment-implant prosthetic diameter and surface treatment. The reference device K191250 serves as a predicate for substantial equivalence of the subject device Temporary Titanium Abutment Indications for Use.
The reference device K191250 also serves as a predicate for substantial equivalence of the subject device PEEK abutment designs and Indications for Use.
The reference device K193084 serves as a predicate for substantial equivalence of the subject device Narrow TIB Abutment Base designs and Indications for Use.
The subject device implants encompass similar ranges of dimensions as the predicate device cleared in K180282. The material, surface treatment applied to the endosseous threads of the implants is identical to that cleared in K163634 and K180465. The material and surface treatment applied to the subject device abutments is identical to that of the abutments cleared in K163634, K180465, K193084 and K191250. All subject device components are for single-patient, single-use, and all are provided sterile (except the Passive Abutments and Narrow TIB Abutment Bases which are provided non-sterile identical to Passive Abutments cleared in K180465 and the TIB Abutment Bases in K193084). Similarly, the components cleared in K180282, K163634, K180465 and K191250 are for single-patient, single-use and are provided sterile (excluding the Passive Abutments and Narrow TIB Abutment Bases).
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 devices in K163634, K180465, K193084 and K191250.
In support of substantial equivalence of the Ø3.30 implants in terms of mechanical performance, dynamic compression-bending testing was performed according to ISO 14801. Dynamic testing was performed on worstcase subject device constructs. The results from the testing demonstrated fatigue performance of the subject device that exceeds its indication. To demonstrate that the subject device 6 mm length Ø4.0 implants are substantially
16
equivalent to a predicate short length implant (cleared in K163634) a report detailing an analysis of the comparative surface area, the comparative bone-to-implant contact and the comparative pull-out strength is provided.
CONCLUSION
The subject device and the predicate devices have a significantly similar intended use, have similar technological characteristics, and are made of the same materials. The subject device and the predicate devices encompass the same range of physical dimensions, including diameter and length of the implants, and the diameter and angulation of the abutments. The subject device and the predicate devices are packaged in similar materials and sterilized using similar methods.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.