Provata Implant System

K222457 · Southern Implants (Pty), Ltd. · DZE · Mar 6, 2023 · Dental

Device Facts

Record IDK222457
Device NameProvata Implant System
ApplicantSouthern Implants (Pty), Ltd.
Product CodeDZE · Dental
Decision DateMar 6, 2023
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

Intended Use

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. 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 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 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 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.

Device Story

Provata Implant System consists of threaded root-form dental implants with internal hexagon interface and various mating abutments (healing, temporary, passive, TIB, conventional). Implants are placed surgically in the jaw by dental clinicians to support prosthetic restorations. TIB abutments integrate into digital dentistry workflows using desktop scanners, CAD/CAM software, and zirconia mesostructures. Device provides mechanical support for crowns, bridges, or overdentures. Benefits include restoration of chewing function and esthetics. System includes Ø3.30 and Ø4.07 mm diameter implants, with straight and 12° angled Co-Axis options. Components are single-patient, single-use. Clinicians use the system to achieve primary stability for immediate or delayed loading. Output is a stable foundation for dental prosthetics.

Clinical Evidence

No clinical data included. Substantial equivalence supported by non-clinical bench testing: biocompatibility (ISO 10993-1), engineering/dimensional analysis, sterilization validation (ISO 11137, ISO 17665), bacterial endotoxin testing, static/dynamic compression-bending fatigue testing (ISO 14801), and MR safety testing.

Technological Characteristics

Implants: Unalloyed titanium (ASTM F67), grit-blasted surface. Abutments: Titanium alloy (ASTM F136) or PEEK. Interface: Internal hexagon. Connectivity: Digital workflow integration via 3Shape Abutment Designer. Sterilization: Gamma irradiation. Software: CAD/CAM design library with locked design limitations.

Indications for Use

Indicated for patients requiring dental implants in the upper or lower jaw for prosthetic attachment of crowns, bridges, or overdentures. Ø3.30 implants limited to replacement of maxillary and mandibular lateral and central incisors. 12° Co-Axis implants restricted to straight abutments. PEEK and temporary titanium abutments indicated for provisional use up to 180 days.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{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) | |------------------------------------------------------------------------------------------------------| | <span> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | <span> <span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ## 510(k) Summary ## Provata Implant System ## Southern Implants (Pty) Ltd ## March 6, 2023 ## ADMINISTRATIVE INFORMATION | Manufacturer Name | Southern Implants (Pty) Ltd<br>1 Albert Road<br>Irene, Gauteng, 0062 South Africa | |-------------------|----------------------------------------------------------------------------------------------------------| | Telephone: | +27 12 667 1046 | | Fax: | +27 12 667 1029 | | Official Contact | Leith C. Cumming<br>Acting Head of Regulatory Affairs and Quality<br>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)<br>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<br>Device | Reference Device | Reference Device | |----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Comparison | Ø3.30 Provata Implant<br>System<br>Southern Implants<br>(Pty) Ltd | K180282<br>MIS Internal Hex<br>Dental Implant System<br>MIS Implants<br>Technologies Ltd | K180465<br>Provata Implant<br>System<br>Southern Implants<br>(Pty) Ltd | K163634<br>External Hex Implants<br>Southern Implants<br>(Pty) Ltd | | Indications for<br>Use Statement | The Provata Implant<br>System is intended for<br>surgical placement in the<br>upper or lower jaw to<br>provide a means for<br>prosthetic attachment of<br>crowns, bridges or<br>overdentures utilizing<br>delayed or immediate<br>loading. The Provata<br>Implant System is<br>intended for immediate<br>function when good<br>primary stability with<br>appropriate occlusal<br>loading is achieved.<br>The intended use for the<br>Ø3.30 Provata implants<br>is limited to replacement<br>of maxillary and<br>mandibular lateral and<br>central incisors.<br>The 12° angled Co-Axis<br>Provata Implants are<br>intended to only be used<br>with straight abutments. | MIS dental implant<br>systems are intended to<br>be surgically placed in<br>the bone of the upper or<br>lower jaw arches to<br>provide support for<br>prosthetic devices, such<br>as artificial teeth, in order<br>to restore masticatory<br>function. When a one-<br>stage surgical procedure<br>is applied, the implant<br>may be immediately<br>loaded when good<br>primary stability is<br>achieved and the occlusal<br>load is appropriate.<br>Narrow implants<br>(Ø3.3mm & UNO) are<br>indicated for use in<br>surgical and restorative<br>applications for<br>placement only in the<br>mandibular central,<br>lateral incisor and<br>maxillary lateral incisor<br>regions of partially<br>edentulous jaws, to<br>provide support for<br>prosthetic devices such as<br>artificial teeth.<br>Mandibular central and<br>lateral incisors must be<br>splinted if using two or<br>more narrow implants<br>adjacent to one another.<br>The long MIS (18 & 20<br>mm) implants can be<br>used in a tilted manner.<br>MIS short implants are to<br>be used only with straight<br>abutments.<br>M4 short implants are<br>indicated for delayed<br>loading only. | The Provata Implant<br>System is intended for<br>surgical placement in the<br>upper or lower jaw to<br>provide a means for<br>prosthetic attachment of<br>crowns, bridges or<br>overdentures utilizing<br>delayed or immediate<br>loading. The Provata<br>Implant System is<br>intended for immediate<br>function when good<br>primary stability with<br>appropriate occlusal<br>loading is achieved. | Southern Implants'<br>External Hex Implants<br>are intended for surgical<br>placement in the upper or<br>lower jaw to provide a<br>means for prosthetic<br>attachment of crowns,<br>bridges or overdentures<br>utilizing delayed or<br>immediate loading.<br>Southern Implants'<br>External Hex Implants<br>are intended for<br>immediate function when<br>good primary stability<br>with appropriate occlusal<br>loading is achieved. | | Product Code<br>Intended Use | DZE<br>Functional and esthetic<br>rehabilitation<br>of<br>the<br>edentulous maxilla. | DZE<br>Intended to be surgically<br>placed in the bone of the<br>upper or lower jaw arches<br>for anchoring<br>or<br>supporting<br>tooth<br>replacement to restore<br>chewing function. | DZE<br>Functional and esthetic<br>rehabilitation<br>of<br>the<br>edentulous maxilla. | DZE<br>Functional and esthetic<br>rehabilitation<br>of<br>the<br>edentulous maxilla. | | Reason for<br>Predicate/Reference | Not applicable | Implant (general design<br>and diameter)<br>Internal hex connection | Implant (general design<br>and diameter)<br>Internal hex connection<br>Indications for Use | Implants (general design,<br>implant length and<br>diameter) | | Item Code | PRO300; MSC-PRO300;<br>PRO12D300; MSC-<br>PRO12D300 | MF7-xx330 (xx indicates<br>implant length) | PRO400; MSC-PRO400;<br>PRO12D400; MSC-<br>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,<br>Relative to<br>orthogonal to<br>implant long axis | 0° and angled 12°<br>(inclined) | 0° (straight) | 0° and angled 12°<br>(inclined) | 0° and angled 12°<br>(inclined) | | Implant Platform<br>Diameter | 3.10 mm for 0° implant,<br>3.0 mm for 12° implant | Not provided | 3.87 mm | 3.43 mm | | Implant Prosthetic<br>Diameter | 2.90 mm | Not provided | 3.575 mm | 3.43 mm | | Machined Collar | Regular implants: 0.6 mm<br>MSC implants: 3 mm | None | Regular implants: 0.6 mm<br>MSC implants: 3 mm | Regular implants: 0.6 mm<br>MSC implants: 3 mm | | Implant Interface | Internal Hex | Internal Hex | Internal Hex | External Hex | | Implant Material | Unalloyed titanium<br>(ASTM F67) Grade 4,<br>and UTS ≥ 900MPa<br>(cold-worked) | Titanium 6Al-4V ELI per<br>ASTM F136 | Unalloyed titanium<br>(ASTM F67) Grade 4,<br>and UTS ≥ 900MPa<br>(cold-worked) | Unalloyed titanium<br>(ASTM F67) Grade 4,<br>and UTS ≥ 900MPa<br>(cold-worked) | | Implant Endosseous<br>Surface | Grit-blasted | Anodized, sand blasted<br>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<br>packaging | 10 years | 5 years | 5 years…
Innolitics
510(k) Summary
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