The TIB Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

Device Description

This submission includes two major components which make up the TIB Abutment Base and the mesostructure restoration.

The TIB Abutment base is a standard premanufactured titanium alloy abutment for supporting a dental restoration and mesostructure. 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, which is designed to fit the abutment base in order to restore chewing for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case by case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration.

The TIB Abutments are compatible with the Southern Implants' Deep Conical, External Hex, Provata and Tri-Nex implants and screws. The TIB abutment bases are manufactured from Titanium alloy conforming to ASTM F136 and are color coded by gold anodizing. The anodization process is the same as used for previously cleared anodized titanium alloy devices in K163634. The Mesostructure restoration is to be manufactured from Zirconia - Sage Max NexxZr which has been previously cleared for use in K 130991.

The digital workflow includes the following products (not subject devices to this submission):

Ceramic material: Sage Max NexxZr Zirconia Restorative material (K130991)
Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436)
Desktop scanner: 3Shape E3 Desktop Scanner is 510(k) exempt under regulation . 872.3661)
Abutment design software: 3Shape Abutment Designer Software (K151455)
Milling machine: Roland DWX51D Milling Machine

AI/ML Overview

The provided text describes the TIB Abutment System and its performance data to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving the device meets those criteria through a study with specific performance metrics.

Therefore, I cannot populate the table or answer questions 2 through 7 directly from the provided text as the document does not present acceptance criteria in a quantitative format, nor does it detail a standalone study with performance metrics for the TIB Abutment System against such criteria. Instead, it relies on comparative equivalence with already cleared devices and various non-clinical tests.

However, I can extract information related to the performance data and ground truth establishment that were conducted as part of the substantial equivalence demonstration.

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" for the TIB Abutment System in a format that would fit a table like the one requested. Instead, it relies on demonstrating substantial equivalence to predicate devices through various non-clinical tests and comparisons. The performance data listed are primarily compliance tests against recognized standards rather than specific device performance metrics against predefined thresholds.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify sample sizes or data provenance (country of origin, retrospective/prospective) for the non-clinical tests mentioned. It only lists the types of tests performed.

3. 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 document refers to non-clinical tests and compliance with standards, not expert-adjudicated ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. The document refers to non-clinical tests and compliance with standards, not expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a dental abutment system, not an AI-assisted diagnostic device, and no MRMC study or AI-related effectiveness is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document describes non-clinical testing of the device components and workflow, which can be considered a form of standalone evaluation for the device itself. The types of standalone tests performed include:

Biocompatibility testing per ISO 10993-1 and ISO 10993-5.
Validated sterilization instructions per ISO 17665-2.
Software validation testing per FDA Guidance.
Scanning and milling validation.
Static and dynamic compression-bending to ISO 14801.
Mechanical ISO 14801 Fatigue Testing for implant platforms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" in this context is established by adherence to recognized international standards and FDA guidance documents for medical device testing. For example:

Biocompatibility: ISO 10993-1 and ISO 10993-5 standards.
Sterilization: ISO 17665-2.
Software Validation: FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices.
Mechanical Testing: ISO 14801.

8. The sample size for the training set:

Not applicable. This document describes a medical device (dental abutment system) and its non-clinical testing for substantial equivalence, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for a machine learning model mentioned.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 27, 2020

Southern Implants (Pty) Ltd Lauranda Breytenbach Head of Regulatory Affairs and Quality 1 Albert Road Irene, Gauteng 0062 REPUBLIC OF SOUTH AFRICA

Re: K193084

Trade/Device Name: TIB Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: October 19, 2020 Received: October 20, 2020

Dear Lauranda Breytenbach:

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 (OS) 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.

for

Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K193084

Device Name TIB Abutment System

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K193084

TIB Abutment System

Southern Implants (Pty) Ltd

October 27, 2020

ADMINISTRATIVE INFORMATION

Manufacturer Name

Official Contact

Southern Implants (Pty) Ltd 1 Albert Road Irene, Gauteng, 0062 South Africa +27 12 667 1046 Telephone Fax +27 12 667 1029

Lauranda G. Breytenbach Head of Regulatory Affairs and Quality Email: lauranda.b(@southernimplants.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary name Common name

Classification name Classification regulation Product Code

Classification Panel Reviewing Branch

TIB Abutment System Dental Abutment

Endosseous Dental Implant Abutment 21 CFR 872.3630, Class II NHA, PNP

Dental Products Panel Dental Devices Branch

PREDICATE DEVICE INFORMATION

The primary predicate device is K180899 The reference predicate devices are K181359, K111421, K163634, K130991, K130436 and K151455

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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.

SUBJECT DEVICE DESCRIPTION

This submission includes two major components which make up the TIB Abutment Base and the mesostructure restoration.

The digital workflow includes the following products (not subject devices to this submission):

Ceramic material: Sage Max NexxZr Zirconia Restorative material (K130991) ●
Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436) ●
Desktop scanner: 3Shape E3 Desktop Scanner is 510(k) exempt under regulation . 872.3661)
. Abutment design software: 3Shape Abutment Designer Software (K151455)
Milling machine: Roland DWX51D Milling Machine ●

PERFORMANCE DATA

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments; Biocompatibility testing per the FDA Guidance Document for Use of Standard ISO 10993-1. "Biological evaluation of medical devices - Partl: Evaluation and testing within a risk management process" and ISO 10993-5 "Biological Evaluation of Medical Devices – Part 5: Tests for In

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Vitro Cytotoxicity": validated sterilization instructions per ISO 17665-2; software validation testing per the FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices; scanning and milling validation; and static and dynamic compression-bending to ISO 14801. No clinical data was included in this submission.

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:

K180899, Universal Base Abutment, Nobel Biocare K111421, Sirona Dental CAD/CAM System, Dentsply Sirona K181359, InterActive SMARTBase Abutments, Implant Direct K163634, External Hex Implants, Southern Implants K130991, Zirconia restorative material, SageMaxx NexxZr K130436, Multilink Hybrid Abutment Cement, Ivoclar Vivadent K151455, 3Shape Abutment Designer Software, 3Shape A/S

The primary predicate is K180899.

The reference predicate devices are K181359, K111421, K163634, K130991, K130436 and K151455.

A comparison of the technological characteristics of the subject device and the predicate devices is provided in the following table.

	Subject Abutment	Primary Predicate	Reference Predicates
Characteristics	SouthernImplantsTIBAbutment	Universal BaseAbutment(K180899)	InterActiveSMARTBaseAbutments (K181359)	SironaCAD/CAM(K111421)	DentalSystem	SouthernImplantsExternal(K163634)
Abutment Design	2 Piece -Premanufacturedtitanium abutment,mounted onto theimplant and fixedwith a screw.SageMaxx Zirconia(K130991)hybrid/crownrestoration milledand bonded to thetitanium abutment.	2 Piece - Enamic(K153645) bonded toUniversal BaseAbutment mountedonto the implant andfixed with a screw	Abutment body consistingof a titanium base andsupplied with a fixationscrew. The bases areprovided with straight,angled, and modifiedzirconia tops for patientspecific devices. Thedevices are also providedwithout a zirconia top anda superstructure or hybridcrown or bridge can bemilled to fit the basesintended to bemanufactured at ImplantDirect Manufacturingfacility's	The TiBase is apremanufacturedprosthetic componentdirectly connected toendosseous dentalimplants with a screwand is intended for useas an aid in prostheticrehabilitation.		Sterile: Cover Screw,Healing Caps,Abutments,Titanium Abutments,AnatomicAbutments, CosmeticAbutments,Compact AbutmentsNon-sterile:Abutments,Chrome Abutments,Passive Abutments
MaximumAbutmentAngulation	20°	20°	30°	20°	-	-
RestorationMaterial	Zirconia - SageMaxx NexxZr(K130991)	Enamic (K153645)	Zenostar MT	Cercon HT	-
Post Height	Minimum 4.5mm	Minimum 5.2mm	Single Unit - Minimum 4 mmMulti-Unit -Minimum 4 mm	Minimum 4mm	-
	Subject Abutment	Primary Predicate	Reference Predicates
Characteristics	SouthernImplantsTIBAbutment	UniversalBaseAbutment(K180899)	Inter ActiveSMARTBaseAbutments (K181359)	SironaDentalCAD/CAMSystem(K111421)	SouthernImplantsExternalHex(K163634)
Screw Thread	1-72 unf-2b, M1.6,M1.8 and M2	Not available	M1.6, M2	M1.6,M2(NobelActive)	M2
CompatibleImplant Platforms	Southern Implants:ExternalHexImplantsProvata ImplantsDeep ConicalImplantsTri-Nex Implants	Nobel BiocareExternal HexNarrow Platform(NP)Regular Platform(RP)Wide Platform (WP)	InterActive SMARTBaseabutments are compatibleat the implant level withInterActive (3.0mm and3.4mm Platform) andSwishActive (3.0mm and3.4mm Platform) systemimplants.	The InCorismesostructure andTiBase two-pieceabutment is compatiblewith the followingimplant systems: NobelBiocare Replace(K020646), NobelBiocare Branemark(K022562), FriadentXive (K013867),Biomet 3i Osseotite(K980549), Astra TechOsseospeed(K091239), ZimmerTapered Screw-Vent(K061410), StraumannSynocta (K061176),Straumann Bone Level(K053088), Biomet 3iCertain (K014235),Nobel Biocare Active(K071370).	SouthernImplantsExternal Hex Implants
CAD/CAM DesignWorkflow	3Shape E3 DesktopScanner (3ShapeA/S). 3ShapeAbutment DesignerSoftware (ShapeA/S)- K151455	3Shape Intra oralscanner Trios(3Shape A/S). 3ShapeAbutment DesignerSoftware (ShapeA/S)- K151455	3M Tru-Definition, ITeroScanner 3ShapeAbutment DesignerSoftware (3Shape A/S) -K151455	Sirona software – inlab15.0 and above Sironasoftware - CEREC 4.4and above
CAD/CAMManufacturingWorkflow	WorkNC CAMsoftware, RolandDWX51D millingunit	CORITEC millingunit (imes-icore)	Wieland-Zenotec Select& Zenotec CAM	CEREC MCXLproduct family
Mechanical Testing	Dynamic FatigueTesting per ISO14801	Dynamic FatigueTesting per ISO14801	Dynamic Fatigue Testingper ISO 14801	Dynamic FatigueTesting per ISO 14801	Dynamic FatigueTesting per ISO 14801
TitaniumAbutment Material	Titanium Grade 5Alloy (ASTMF136)	Titanium VanadiumAlloy (ASTM F136)	Titanium	TiBase - Titanium6AL4V	Titanium Grade 5Alloy (ASTM F136)
Abutment SurfaceTreatment	Machined andAnodized gold		Abutments are titaniumanodized gold and pink(grooves are machined forcement adhesion).	Cemented surfaces areblasted with aluminumoxide.	Anodized, Grooved
Screw Material	Titanium Grade 5(ASTM F136)	Titanium	Titanium	Titanium	Titanium Grade 5(ASTM F136)
Sterility	Supplied non-sterile	Supplied non-sterile	Supplied non-sterile	Supplied non-sterile	Supplied sterile
Use	Single-Use		Single-Use	Single-Use	Single-Use
Indications for Use	The TIBAbutments arepremanufacturedprostheticcomponents directlyconnected toendosseous dentalimplants and areintended for use asan aid inprostheticrehabilitation. TheTIB abutments	The Universal BaseAbutments arepremanufacturedprostheticcomponents directlyconnected toendosseous dentalimplants and areintended for use asan aid in prostheticrehabilitation. TheUniversal Base	InterActive/SwishActiveImplant System consistsof two-piece implants forone-stage or two-stagesurgical procedures.These implants areintended for use inpartially and fullyedentulous upper andlower jaws in support ofsingle or multiple unitrestorations and terminal	The Sirona DentalCAD/CAM System isintended for use inpartially or fullyedentulous mandiblesand maxillae in supportof single or multipleunit cement retainedrestorations. Thesystem consists ofthree major parts:TiBase, InCoris	Southern Implants'External Hex Implantsare intended forsurgical placement inthe upper or lowerjaw to provide a meansfor prostheticattachment of crowns,bridges or overdenturesutilizing delayed orimmediate loading.
Characteristics	Subject Abutment	Primary Predicate	Reference Predicates
	SouthernImplantsTIBAbutment	UniversalBaseAbutment(K180899)	InterActiveSMARTBaseAbutments (K181359)	SironaDentalCAD/CAMSystem(K111421)	SouthernImplants'ExternalHex(K163634)
	consists of twomajor parts.Specifically, thetitanium base andmesostructurecomponents makeup a two-pieceabutment.The systemintegratesmultiplecomponents of thedigital dentistryworkflow: Scanfiles from desktopscanners, CADsoftware, CAMsoftware, ceramicmaterial, millingmachine andassociated toolingand accessories.	two major parts.Specifically, thetitanium base andmesostructurecomponents make upa two-piece abutment.The system integratesmultiple componentsof the digital dentistryworkflow: scan filesfrom Intra-OralScanners, CADsoftware, CAMsoftware, ceramicmaterial, millingmachine andassociated tooling andaccessories.	SMARTBase abutmentsupport for fixedbridgework. The systemintegrates multiplecomponents of the digitaldentistry workflow: scanfiles from Intra-OralScanners, CAD software,CAM software, ceramicmaterial, milling machineand associated tooling andaccessories.TheSMARTBase Abutmentsconsist of two major parts.Specifically, the titaniumbase and zirconia topcomponents make up atwo-piece abutment.Implants can be indicatedfor immediate loadingwhen good primarystability has beenachieved and withappropriate occlusalloading. Narrow Diameter(3.2, 3.3mm) Implants:Indicated for single-toothreplacement ofmandibular central andlateral incisors andmaxillary lateral incisors.Also indicated formultiple toothreplacements or denturestabilization.	CAD/CAM software.Specifically, theInCoris mesostructureand TiBasecomponents make up atwo-piece abutmentwhich is used inconjunction withendosseous dentalimplants to restore thefunction and aestheticsin the oral cavity. TheInCoris mesostructuremay also be used inconjunction with theCamlog Titanium baseCAD/CAM (typesK2244.xxxx)(K083496) in theCamlog ImplantSystem.TheCAD/CAM software isintended to design andfabricate the InCorismesostructure.	Southern Implants'External Hex Implantsare intended forimmediate functionwhen goodprimary stability withappropriate occlusalloading is achieved.

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The Indications for Use Statement for the subject device is the same as that of the primary predicate device

K K 000 States 1.10 de same the comments of the shier der abies der abies deriver anders anderse anderse armer
The subject devier Listes in the market ber antier der seteller

The primary predicate and the subject device have the identical maximum angulation for t restoration and follow an equivalent design workflow. In the design workflow the primary predicate uses a different scanner but the same software to design the restoration. The design workflow differing with the scanner does not impact demonstrating substantial equivalence. The difference in scanner was shown to not affect substantial equivalence by way of software validation, scanning and milling validation, and static and dynamic compression-bending according to ISO 14801.

The subject device is also substantially equivalent to the primary predicate with reference to the abutment's restoration material with the subject and the primary predicate both making use of a ceramic composite riate performance testing on the ceramic component of the two-piece abutment. The both the subject device and primary predicate is a um Allov (ASTM

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F136), the screw material is Titanium for both the subject and primary predicate. Both the subject and the primary predicate devices are provided non-sterile. Thus, the abutment materials and method provided of the subject device are substantially equivalent to that of the primary predicate. The different manufacturing and ceramic material comparison were addressed with biocompatibility testing per the FDA Guidance Document for Use of Standard ISO 10993-1. "Biological evaluation of medical devices – Partly Evaluation and testing within a risk management process", and validated sterilization instructions per the FDA Guidance Document for Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labelling.

The reference predicate K181359 is for substantial equivalence of the Subject Device screw thread, manufacturing workflow, abutment surface treatment and usage. The subject device makes use of the same screw threads as the reference device (K181359) with a difference of the 1-72 unf-2b (1.85mm) and M1.8 screw threads. The screw threads differing with the addition of intermediary screw threads does not impact demonstrating substantial equivalence, and this was shown with static and dynamic compression-bending according to ISO 14801.

In terms of the manufacturing workflow, the subject device makes use of the WorkNC CAM software and a Roland DWX51D milling unit. The reference device (K181359) Makes use of Zenotec CAM and Wieland-Zenotec Select milling unit. While both are different brands, both devices make use of CAM software, communicating with a milling unit. The manufacturing workflow differing with CAM software and milling unit brands does not impact demonstrating substantial equivalence, and this was shown by of software validation, scanning and milling validation, and dynamic compression-bending according to ISO 14801.

The reference device (K163634) is for substantial equivalence of abutment material, surface treatment and packaging methods. The subject device abutments are manufactured from Titanium alloy conforming to ASTM F136 and are color coded by anodizing. The anodization process is the same as that used for the reference device (K163634). Both the subject and the reference device are packaged with the same methods for single use. Thus, the material, surface treatment and packaging methods of the subject device is considered substantially equivalent to that of the reference device.

The reference predicate K111421 is for substantial equivalence of the compatible implant platforms. The subject device is designed to connect directly to the Southern Implants External Hex, Deep Conical and Tri-Nex connection types. While the reference device (K111421) is designed to connect directly to multiple different implant systems, which together encompass the same range of implant platform types as that of the subject device. This, with the addition of Mechanical ISO 14801 Fatigue Testing of all four implant platforms proves substantial equivalence of the compatible implant platforms.

The post height of the subject device is indicated to a minimum of 4.5mm. The primary predicate (K180899) is indicated to a minimum of 5.2mm, while the reference device (K181359) is indicated to a minimum of 4mm. The subject device post height lies between these two predicate minimums and is thus substantially equivalent.

Substantial equivalence of the subject device components in terms of biocompatibility is supported by the fact that materials are identical in formulation, processing, component interactions, and storage conditions to the predicate devices in K163634. Furthermore, biocompatibility testing per the FDA Guidance Document for Use of Standard ISO 10993-1, "Biological evaluation of medical devices – Part1: Evaluation and testing within a risk management process" was performed.

The inclusion of the 3Shape software (K151455) was validated with performance testing per the FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices.

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Overall the subject device has the following similarities to the predicate devices:

Has the same intended use
· Incorporates the same basic design
· Incorporates the same or very similar materials,
· Follows the equivalent design and manufacturing workflows,
· Incorporates the same abutment surface treatment and packaging
Has a similar fatigue limit

CONCLUSION

The subject device and the primary predicate have the same intended use, except for the different scanner. The subject device and predicate devices all incorporate the same materials and basic design. The subject device and the predicate devices are for substantial equivalence of surface treatment and patient usage, and are provided non-sterile. The subject device and the primary predicate follow the same design and manufacturing CAD/CAM workflows.

The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)