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 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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Provata Implant System, which describes various dental implants and abutments. It focuses on demonstrating substantial equivalence to predicate devices and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria beyond the general statement of "demonstrated fatigue performance of the subject device that exceeds its indication" based on ISO 14801 testing.

Therefore, most of the requested information cannot be extracted from the given text.

However, I can extract information related to performance testing and mention the lack of specific acceptance criteria and performance reports.

A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the document. The document states that "Dynamic testing was performed on worst-case subject device constructs. The results from the testing demonstrated fatigue performance of the subject device that exceeds its indication." However, no specific acceptance criteria or quantitative performance results are reported.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document only mentions "worst-case subject device constructs" were used for dynamic compression-bending testing.
- Data Provenance: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The reported testing is non-clinical (mechanical fatigue testing), not related to clinical ground truth established by experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study involving adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case comparative effectiveness study was not done. This submission is for dental implants and abutments, and the non-clinical performance data focuses on mechanical and biological characteristics, not AI-assisted human reading.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The performance data is based on non-clinical mechanical testing and material equivalence.
The sample size for the training set
Not applicable. This is not an AI/machine learning device requiring a training set.
How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.

Summary

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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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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

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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:

Indications for Use for the Temporary Titanium Abutments:

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.

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510(k) Summary

Provata Implant System

Southern Implants (Pty) Ltd

March 6, 2023

ADMINISTRATIVE INFORMATION

Manufacturer Name	Southern Implants (Pty) Ltd1 Albert RoadIrene, Gauteng, 0062 South Africa
Telephone:	+27 12 667 1046
Fax:	+27 12 667 1029
Official Contact	Leith C. CummingActing Head of Regulatory Affairs and QualityEmail: 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:

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Indications for Use for the TIB Abutments:

Indications for Use for the Conventional Abutments and Prosthetic Screws:

Indications for Use for the PEEK Temporary Abutments:

Indications for Use for the Temporary Titanium Abutments:

SUBJECT DEVICE DESCRIPTION

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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.

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	Subject Device	Primary PredicateDevice	Reference Device	Reference Device
Comparison	Ø3.30 Provata ImplantSystemSouthern Implants(Pty) Ltd	K180282MIS Internal HexDental Implant SystemMIS ImplantsTechnologies Ltd	K180465Provata ImplantSystemSouthern Implants(Pty) Ltd	K163634External Hex ImplantsSouthern Implants(Pty) Ltd
Indications forUse Statement	The Provata ImplantSystem is intended forsurgical placement in theupper or lower jaw toprovide a means forprosthetic attachment ofcrowns, bridges oroverdentures utilizingdelayed or immediateloading. The ProvataImplant System isintended for immediatefunction when goodprimary stability withappropriate occlusalloading is achieved.The intended use for theØ3.30 Provata implantsis limited to replacementof maxillary andmandibular lateral andcentral incisors.The 12° angled Co-AxisProvata Implants areintended to only be usedwith straight abutments.	MIS dental implantsystems are intended tobe surgically placed inthe bone of the upper orlower jaw arches toprovide support forprosthetic devices, suchas artificial teeth, in orderto restore masticatoryfunction. When a one-stage surgical procedureis applied, the implantmay be immediatelyloaded when goodprimary stability isachieved and the occlusalload is appropriate.Narrow implants(Ø3.3mm & UNO) areindicated for use insurgical and restorativeapplications forplacement only in themandibular central,lateral incisor andmaxillary lateral incisorregions of partiallyedentulous jaws, toprovide support forprosthetic devices such asartificial teeth.Mandibular central andlateral incisors must besplinted if using two ormore narrow implantsadjacent to one another.The long MIS (18 & 20mm) implants can beused in a tilted manner.MIS short implants are tobe used only with straightabutments.M4 short implants areindicated for delayedloading only.	The Provata ImplantSystem is intended forsurgical placement in theupper or lower jaw toprovide a means forprosthetic attachment ofcrowns, bridges oroverdentures utilizingdelayed or immediateloading. The ProvataImplant System isintended for immediatefunction when goodprimary stability withappropriate occlusalloading is achieved.	Southern Implants'External Hex Implantsare intended for surgicalplacement in the upper orlower jaw to provide ameans for prostheticattachment of crowns,bridges or overdenturesutilizing delayed orimmediate loading.Southern Implants'External Hex Implantsare intended forimmediate function whengood primary stabilitywith appropriate occlusalloading is achieved.
Product CodeIntended Use	DZEFunctional and estheticrehabilitationoftheedentulous maxilla.	DZEIntended to be surgicallyplaced in the bone of theupper or lower jaw archesfor anchoringorsupportingtoothreplacement to restorechewing function.	DZEFunctional and estheticrehabilitationoftheedentulous maxilla.	DZEFunctional and estheticrehabilitationoftheedentulous maxilla.
Reason forPredicate/Reference	Not applicable	Implant (general designand diameter)Internal hex connection	Implant (general designand diameter)Internal hex connectionIndications for Use	Implants (general design,implant length anddiameter)
Item Code	PRO300; MSC-PRO300;PRO12D300; MSC-PRO12D300	MF7-xx330 (xx indicatesimplant 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 toorthogonal toimplant long axis	0° and angled 12°(inclined)	0° (straight)	0° and angled 12°(inclined)	0° and angled 12°(inclined)
Implant PlatformDiameter	3.10 mm for 0° implant,3.0 mm for 12° implant	Not provided	3.87 mm	3.43 mm
Implant ProstheticDiameter	2.90 mm	Not provided	3.575 mm	3.43 mm
Machined Collar	Regular implants: 0.6 mmMSC implants: 3 mm	None	Regular implants: 0.6 mmMSC implants: 3 mm	Regular implants: 0.6 mmMSC 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 perASTM F136	Unalloyed titanium(ASTM F67) Grade 4,and UTS ≥ 900MPa(cold-worked)	Unalloyed titanium(ASTM F67) Grade 4,and UTS ≥ 900MPa(cold-worked)
Implant EndosseousSurface	Grit-blasted	Anodized, sand blastedand 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 ofpackaging	10 years	5 years	5 years	5 years

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	Subject Device	Reference Device
Comparison	Conventional Abutments for Ø3.30 ProvataImplant System	K180465
	Southern Implants (Pty) Ltd	Provata Implant System
		Southern Implants (Pty) Ltd
Indications for UseStatement	The Conventional Abutments and ProstheticScrews are premanufactured prostheticcomponents directly connected to endosseousdental implants and intended for use in fullyedentulous or partially edentulous maxilla and/ormandible to provide support for crowns, bridgesor overdentures.	The Provata Implant System is intended forsurgical placement in the upper or lower jaw toprovide a means for prosthetic attachment ofcrowns, bridges or overdentures utilizing delayedor immediate loading. The Provata ImplantSystem is intended for immediate function whengood primary stability with appropriate occlusalloading is achieved.

Product Code	NHA	NHA
Intended Use	Functional and esthetic rehabilitation of theedentulous maxilla.	Functional and esthetic rehabilitation of theedentulous maxilla.
Reason forPredicate/Reference	Not applicable	General design of Cover Screw, HealingAbutment, Passive Abutment, and CompactConical AbutmentIndications 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 andmulti-unit	Engaging and non-engaging; Single-unit andmulti-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 goldalloy
Compact Conical Abutment
Item Code	MC-3M; MC-3M-20D	MC-M; MC-M-20D; MC-M-30D
Connection configurations	0°: Non-engaging; Multi-unit20°: Engaging; Multi-unit	0°: Non-engaging; Multi-unit20° and 30°: Engaging; Multi-unit
Prosthesis attachment	Screw-retained	Screw-retained
Collar height	0°: 1, 3, 5 mm20°: 1.56 mm – 3.20 mm	0°: 1, 3, 5 mm
		20°: 1.21 mm - 2.85 mm30°: 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 TiNcoating	Titanium alloy (ASTM F136) Grade 5, with TiNcoating
Abutment screw material	Titanium alloy (ASTM F136) Grade 5	Titanium alloy (ASTM F136) Grade 5
How Provided
Sterility	Provided sterileCover ScrewsHealing AbutmentsCompact Conical AbutmentsAll abutment screwsProvided nonsterilePassive Abutments	Provided sterileCover ScrewsHealing AbutmentsCompact Conical AbutmentsAll abutment screwsProvided nonsterilePassive Abutments
Sterilization	Gamma irradiation	Gamma irradiation
Usage	Single-patient, single-use	Single-patient, single-use
Shelf life of packaging	5 years	5 years

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	Subject Device	Reference Device	Reference Device
Comparison	Temporary Titanium Abutmentsfor Ø3.30 Provata ImplantSystemSouthern Implants (Pty) Ltd	K180465Provata Implant SystemSouthern Implants (Pty) Ltd	K191250Southern Implants PEEKabutmentsSouthern Implants (Pty) Ltd
Temporary Titanium Abutment
Indications forUse Statement	The Southern Implants TemporaryTitanium Abutments arepremanufactured prostheticcomponents directly connected toendosseous dental implants and areintended for provisional use up to180 days as an aid in prostheticrehabilitation.	The Provata Implant System isintended for surgical placement inthe upper or lower jaw to provide ameans for prosthetic attachment ofcrowns, bridges or overdenturesutilizing delayed or immediateloading. The Provata ImplantSystem is intended for immediatefunction when good primarystability with appropriate occlusalloading is achieved.	The Southern Implants PEEKAbutments are premanufacturedprosthetic components directlyconnected to endosseous dentalimplants and are intended forprovisional use up to 180 days asan 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 estheticrehabilitation of the edentulousmaxilla.	Functional and estheticrehabilitation of the edentulousmaxilla.	Temporary Abutment
Reason forPredicate/Reference	Not applicable	Titanium Cylinder Abutmentdesign	Indications for Use
Connectionconfigurations	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
Prosthesisattachment	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 screwmaterial	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 ofpackaging	5 years	5 years	5 years

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	Subject Device	Reference Device
Comparison	PEEK Abutments for Ø3.30 Provata ImplantSystemSouthern Implants (Pty) Ltd	K191250Southern Implants PEEK abutmentsSouthern Implants (Pty) Ltd
PEEK Abutment
Indications for UseStatement	The Southern Implants PEEK Abutments arepremanufactured prosthetic components directlyconnected to endosseous dental implants and areintended for provisional use up to 180 days as anaid in prosthetic rehabilitation.	The Southern Implants PEEK Abutments arepremanufactured prosthetic components directlyconnected to endosseous dental implants and areintended for provisional use up to 180 days as anaid 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 forPredicate/Reference	Not applicable	PEEK abutment (all aspects of device design andIndications for Use)
Connection configurations	Engaging and non-engaging; Single-unit andmulti-unit	Engaging and non-engaging; Single-unit andmulti-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 goldalloy
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

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	Subject Device	Reference Device
Comparison	Narrow TIB Abutment Bases for Ø3.30Provata Implant SystemSouthern Implants (Pty) Ltd	K193084TIB Abutment SystemSouthern Implants (Pty) Ltd
Narrow TIB Abutment Base
Indications for UseStatement	The TIB Abutments are premanufacturedprosthetic components directly connected toendosseous dental implants and are intended foruse as an aid in prosthetic rehabilitation. The TIBabutments consist of two major parts. Specifically,the titanium base and mesostructure componentsmake up a two-piece abutment. The systemintegrates multiple components of the digitaldentistry workflow: Scan files from desktopscanners, CAD software, CAM software, ceramicmaterial, milling machine and associated toolingand accessories.	The TIB Abutments are premanufacturedprosthetic components directly connected toendosseous dental implants and are intended foruse as an aid in prosthetic rehabilitation. The TIBabutments consist of two major parts. Specifically,the titanium base and mesostructure componentsmake up a two-piece abutment. The systemintegrates multiple components of the digitaldentistry workflow: Scan files from desktopscanners, CAD software, CAM software, ceramicmaterial, milling machine and associated toolingand accessories.
Product Code	NHA, PNP	NHA, PNP
Item Code	TIBS-3M-C1.5TIBS-3M-C3	TIB-M-C1.5TIB-M-C3
Intended Use	Permanent abutment	Permanent abutment
Reason forPredicate/Reference	Not applicable	Abutment (general design and functioning)Software CompatibilityIndications for Use
Abutment design	2 Piece - Premanufactured titanium abutment,mounted onto the implant and fixed with a screw.SageMaxx Zirconia (K130991) hybrid/crownrestoration milled and bonded to the titaniumabutment.	2 Piece - Premanufactured titanium abutment,mounted onto the implant and fixed with a screw.SageMaxx Zirconia (K130991) hybrid/crownrestoration milled and bonded to the titaniumabutment.
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 RestorativePlatform 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 ManufacturingWorkflow	WorkNC CAM software, Roland DWX51Dmilling unit	WorkNC CAM software, Roland DWX51Dmilling 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

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	Subject Device	Reference Device	Reference Device
Comparison	6mm Ø4.0 Provata ImplantSystemSouthern Implants (Pty) Ltd	K163634External Hex ImplantsSouthern Implants (Pty) Ltd	K180465Provata Implant SystemSouthern Implants (Pty) Ltd
6 mm length Ø4.0 Implant
Indications forUse Statement	The Provata Implant System isintended for surgical placement inthe upper or lower jaw to provide ameans for prosthetic attachment ofcrowns, bridges or overdenturesutilizing delayed or immediateloading. The Provata ImplantSystem is intended for immediatefunction when good primarystability with appropriate occlusalloading is achieved.The intended use for the Ø3.30Provata implants is limited toreplacement of maxillary andmandibular lateral and centralincisors.The 12° angled Co-Axis ProvataImplants are intended to only beused with straight abutments	Southern Implants' External HexImplants are intended for surgicalplacement in the upper or lower jawto provide a means for prostheticattachment of crowns, bridges oroverdentures utilizing delayed orimmediate loading. SouthernImplants' External Hex Implantsare intended for immediate functionwhen good primary stability withappropriate occlusal loading isachieved.	The Provata Implant System isintended for surgical placement inthe upper or lower jaw to provide ameans for prosthetic attachment ofcrowns, bridges or overdenturesutilizing delayed or immediateloading. The Provata ImplantSystem is intended for immediatefunction when good primarystability with appropriate occlusalloading is achieved.
Product Code	DZE	DZE	DZE
Intended Use	Functional and estheticrehabilitation of the edentulousmaxilla.	Functional and estheticrehabilitation of the edentulousmaxilla.	Functional and estheticrehabilitation of the edentulousmaxilla.
Reason forPredicate/Reference	Not applicable	Implant DesignImplant Length	Implant (general design anddiameter)Internal hex connectionIndications for Use
Item Code	PRO406; MSC-PRO406	IBT; MSC-IBT	PRO400; MSC-PRO400;
Implant Design	Fully threaded tapered root-formdental implants	Fully threaded tapered root-formdental implants	Fully threaded tapered root-formdental 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 toorthogonal toimplant long axis	0°	0°	0°
Implant PlatformDiameter	3.87 mm	4.07 mm	3.87 mm
Implant ProstheticDiameter	3.575 mm	4.07 mm	3.575 mm
Machined Collar	Regular implants: 0.6 mmMSC implants: 2 mm	Regular implants: 0.6 mmMSC implants: 3 mm	Regular implants: 0.6 mmMSC 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)
ImplantEndosseous 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

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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

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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.

Regulation Number and Section

§ 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.