InterActive/SwishActive Implant System consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate SMARTBase support for fixed bridgework. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTBase Abutments consist of two major parts. Specifically, the titanium base and zirconia top components make up a two-piece abutment.

Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Narrow Diameter (3.2. 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.

Device Description

The InterActive SMARTBase abutments system is a line extension of the previously cleared Implant Direct device, 2014 InterActive/SwishActive Implant System. The InterActive SMARTBase abutments are comprised of engaging abutments, non-engaging abutments, modified zirconia engaging abutments, modified zirconia non-engaging multiunit bridges, and fixation screws that are intended to function as an extension of the implant. The proposed SMARTBase Abutment is a two-piece abutment consisting of titanium base and zirconia top components. To fabricate the zirconia top component that fits the titanium base, there are three workflow options: (1) using a press-ceramic material that is formed by conventional wax-up technique by the end user, (2) the zirconia top component is designed and milled by Implant Direct in stock sizes and provided to the end user to be placed on the titanium base for forming two-piece abutment, and (3) digital workflow using 3Shape where CAD design and milling of the zirconia top component is done at the end user's dental laboratory/office to be placed on the titanium base. The CAD design requires loading of Implant Direct abutment design library to the 3Shape Software to design the zirconia top component within the established design limitations and specifications.

AI/ML Overview

The provided document describes the FDA's 510(k) clearance for the InterActive SMARTBase Abutments, which is a dental implant component. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might find for a novel AI device.

Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes for test/training sets, expert consensus, MRMC studies, or standalone performance is not applicable or not present in this regulatory submission for a dental abutment. The submission primarily relies on non-clinical testing to demonstrate that the changes from the predicate device do not negatively impact safety or effectiveness.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table with specific numerical acceptance criteria and corresponding performance metrics for the SMARTBase abutments in a typical AI/software validation format. Instead, it describes general testing categories and their successful completion.

Acceptance Criteria Category	Reported Device Performance
Mechanical Strength	Successfully completed endurance testing per ISO 14801; equivalent to predicate devices.
Screw Torque	Met specified torque with worst-case drivers; equivalent to predicate device.
Biocompatibility	Met biocompatibility requirements for intended use per ISO 10993-1 and ISO 10993-5 (cytotoxicity testing).
Software Verification & Validation	Restrictions prevent design of zirconia top component outside design limitations; established design limitations and specifications are locked and cannot be modified within the abutment design library. Screenshots were included in user verification testing.
Steam Sterilization	Expected to meet the same sterilization requirements as predicate devices (validation performed on predicate per ISO 17665-1 and ISO 17665-2), due to same materials, manufacturing processes, and sterilization parameters.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not explicitly stated for each test beyond "worst-case configuration" for mechanical fatigue and "worst case drivers" for screw torque.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The testing appears to be primarily laboratory-based non-clinical testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

Not Applicable. This type of information is typically for devices involving human interpretation of data (e.g., imaging diagnosis). The current device is a physical dental implant abutment, and its "ground truth" is established through engineering and material testing standards.

4. Adjudication Method for the Test Set:

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of cases, typically in diagnostic or screening AI applications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study is for evaluating human performance with and without AI assistance in diagnostic tasks. The InterActive SMARTBase Abutments are physical devices, not an AI software meant to assist human readers.

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

Not Applicable in the traditional sense of an AI algorithm. While software is mentioned (3Shape Abutment Designer™ Software), its role is in designing the physical component, not in making a standalone medical decision. The software itself underwent "verification and validation testing" to ensure it adheres to design rules and limitations for the physical device. The device itself (the abutment) does not operate as a standalone algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device revolves around engineering specifications, material properties, and established international standards (e.g., ISO 14801 for fatigue testing, ISO 10993 for biocompatibility, ISO 17665 for sterilization). The successful completion of these standardized tests serves as the evidence of meeting the necessary performance and safety benchmarks. There is no "expert consensus," "pathology," or "outcomes data" ground truth as would be relevant for a diagnostic or predictive device.

8. The Sample Size for the Training Set:

Not Applicable. This refers to training data for machine learning models. This device is a physical implant component, not an AI model that requires a training set. The "abutment design library" is an engineering dataset, not a machine learning training set.

9. How the Ground Truth for the Training Set was Established:

Not Applicable. See point 8. The "ground truth" for the design library (if one were to interpret "training set" very loosely for a design context) would be established through engineering design principles, material science, and prior validated designs, ensuring the resulting physical abutments meet functional and safety requirements.

Summary

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August 15, 2018

Implant Direct Sybron Manufacturing LLC Reina Choi Senior Regulatory Affairs Specialist 3050 East Hillcrest Drive Thousand Oaks, California 91362

Re: K181359

Trade/Device Name: InterActive SMARTBase Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: May 18, 2018 Received: May 22, 2018

Dear Reina Choi:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Food and Drug Administration

Indications for Use

Expiration Date: 06/30/2020

See PRA Statement below.

510(k) Number (if known)

K181359

Device Name

InterActive SMARTBase Abutments

Indications for Use (Describe)

InterActive/SwishActive Implant System consists of two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or internediate SMARTBase support for fixed bridgework. The system integrates of the digital dentistry workflow scan files from Intra-Oral Scanners, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTBase Abutments consist of two major parts. Specifically, the titanium base and zirconia top components make up a two-piece abutment.

lmplants can be indicated for immediate loading when stability has been achieved and with appropriate occlusal loading.

Narrow Diameter (3.2, 3.3mm) Implants: Indicated for single-tooth replacement of mandbular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.
Compatibility:

InterActive SMARTBase abutments are compatible at the implant level with InterActive (3.0mm and 3.4mm Platform) and SwishActive (3.0mm and 3.4mm Platform) system implants.

Manufacturer	Implant Line	Body Diameter	Implant Platform
Implant Direct	InterActive	3.2mm, 3.7mm, 4.3mm, 5.0mm	3.0mm, 3.4mm
Implant Direct	SwishActive	3.3mm, 4.1mm, 4.8mm	3.0mm, 3.4mm

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CER 801 Subpart D)	☐ Over-The-Counter Use (21 CER 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Implant Direct. The logo consists of an orange and gray graphic on the left, followed by the text "IMPLANT DIRECT" in gray. The "TM" symbol is located to the right of the word "DIRECT".

3050 E. Hillcrest Drive
Thousand Oaks, CA 91362 USA

K181359

510(k) SUMMARY

1. SUBMITTER

Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362

Date Prepared: August 3, 2018

Contact Person: Reina Choi Senior Regulatory Affairs Specialist 818-444-3306 reina.choi@implantdirect.com

2. DEVICE NAME

Proprietary Name:	InterActive SMARTBase Abutments
Classification Name:	Endosseous Dental Implant Abutment(21 CFR 872.3630)
Primary Product Code:	NHA
Secondary Product Code:	PNP

3. PREDICATE DEVICE(S)

InterActive/SwishActive Implant System (K143011) Primary Predicate ●
. InterActive/SwishPlus2 Implant System (K130572) - Reference Device
Sirona Dental CAD/CAM System (K111421) Reference Device .
3Shape Abutment Designer™ Software (K151455) Reference Device .

4. DEVICE DESCRIPTION

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. Ceramic material: Zenostar MT
Cement: EMBRACE Wetbond Resin Cement .
Intra oral scanners: 3M Tru-Definition, ITero Scanner
Abutment design software: 3Shape Abutment Designer™ Software (K151455) ●
Milling machine: Wieland-Zenotec Select & Zenotec CAM .

Type	Material	Implant Platform/Connection Hex	Abutment Diameter/Cuff Heights	PostHeights	Angulation
EngagingAbutments	TitaniumAlloy/Zirconia	3.0mmD/2.2mm3.4mmD/2.6mm	4.9mm Minimum/1mm & 2mm	4mmMinimum	0° to 30°
Non-engagingAbutments	TitaniumAlloy/Zirconia	3.0mmD3.4mmD	5.7mm Minimum/1mm & 2mm	4mmMinimum	0° to 30°
StandardStraight andAngledZirconiaengagingAbutments	TitaniumAlloy/Zirconia	3.0mmD/2.2mm3.4mmD/2.6mm	4.9 mm Minimum/1mm & 2mm	4mmMinimum	0°, 8°, 15°
ModifiedZirconiaengaging	TitaniumAlloy/Zirconia	3.0mmD/2.2mm3.4mmD/2.6mm	4.9mm Minimum/1mm & 2mm	4mmMinimum	0° to 30°

TABLE 1. Product Specifications

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Abutments
Modifiedzirconia non-engagingmulti-unitbridges	TitaniumAlloy/Zirconia	3.0mmD3.4mmD	5.7mm Minimum/1mm & 2mm	N/A	0 to 30°
FixationScrews	TitaniumAlloy	3.0mmD3.4mmD	N/A	N/A	N/A

TABLE 2. Compatible Implants with Proposed InterActive SMARTBase Abutments

Implant Brand(Manufacturer)	510(k) #	Model
Implant Direct SybronManufacturing, LLC	K143011 K130572	InterActive Implant System andSwishActive Implant System (Conicalconnection)

5. INDICATIONS FOR USE

Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Narrow Diameter (3.2. 3.3mm) Implants: Indicated for single-tooth replacement of ● mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.

Compatibility:

InterActive SMARTBase abutments are compatible at the implant level with InterActive (3.0mm and 3.4mm Platform) and SwishActive (3.0mm and 3.4mm Platform) system implants.

Manufacturer	Implant Line	Body Diameter	Implant Platform
--------------	--------------	---------------	------------------

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Implant Direct	InterActive	3.2mm, 3.7mm, 4.3mm, 5.0mm	3.0mm, 3.4mm
Implant Direct	SwishActive	3.3mm, 4.1mm, 4.8mm	3.0mm, 3.4mm

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TechnologicalCharacteristics	Proposed Device:InterActiveSMARTBase Abutments(K181359)	Primary Predicate:InterActive EngagingAbutments(K143011)	Reference Device:InterActive Non-EngagingAbutments (K130572)	Reference Device: SironaDental CAD/CAM-System(K111421)	Reference Device:3Shape AbutmentDesigner™ Software(K151455)
Manufacturer	Implant Direct SybronManufacturing, LLC	Implant Direct SybronManufacturing, LLC	Implant Direct SybronManufacturing, LLC	Dentsply - Sirona	3Shape
Indications forUse	InterActive/SwishActive ImplantSystem consists of two-pieceimplants for one-stage or two-stage surgical procedures. Theseimplants are intended for use inpartially and fully edentulousupper and lower jaws in supportof single or multiple-unitrestorations and terminal orintermediate SMARTBaseabutment support for fixedbridgework. The systemintegrates multiple componentsof the digital dentistry workflow:scan files from Intra-OralScanners, CAD software, CAMsoftware, ceramic material,milling machine and associatedtooling and accessories. TheSMARTBase Abutments consistof two major parts. Specifically,the titanium base and zirconiatop components make up a two-piece abutment.Implants can be indicated forimmediate loading when goodprimary stability has been	InterActive/SwishActiveImplant System consists oftwo-piece implants for one-stage or two-stage surgicalprocedures. These implants areintended for use in partially andfully edentulous upper andlower jaws in support of singleor multiple-unit restorationsand terminal or intermediateabutment support for fixedbridgework.Implants can be indicated forimmediate loading when goodprimary stability has beenachieved and with appropriateocclusal loading.Narrow Diameter (3.2, 3.3mm)Implants: Indicated for single-tooth replacement ofmandibular central and lateralincisors and maxillary lateralincisors. These implants arealso indicated for multiple toothreplacements or denturestabilization.	InterActive/SwishPlus2Implant System consists oftwo-piece implants for one-stage or two-stage surgicalprocedures. These implantsare intended for use inpartially and fully edentulousupper and lower jaws insupport of single or multiple-unit restorations and terminalor intermediate abutmentsupport for fixed bridgework.Implants can be indicated forimmediate loading when goodprimary stability has beenachieved and with appropriateocclusal loading.Narrow Diameter (3.2.3.3mm) Implants: Indicatedfor single-tooth replacement ofmandibular central and lateralincisors and maxillary lateralincisors. Also indicated formultiple tooth replacements ordenture stabilization.	The Sirona Dental CAD/CAMSystem is intended for use inpartially or fully edentulousmandibles and maxillae insupport of single or multiple-unit cement retainedrestorations. The systemconsists of three major parts:TiBase, InCoris mesostructure,and CAD/CAM software.Specifically, the InCorismesostructure and TiBasecomponents make up a two-piece abutment which is usedin conjunction withendosseous dental implants torestore the function andaesthetics in the oral cavity.The InCoris mesostructuremay also be used inconjunction with the CamlogTitanium base CAD/CAM(types K2244.xxxx)(K083496) in the CamlogImplant System. TheCAD/CAM software isintended to design andfabricate the InCorismesostructure.	The 3Shape AbutmentDesigner Software isintended as an aid to therestoration of chewingfunction in partially orfully edentulousmandibles and maxillae.The 3Shape AbutmentDesigner Software isintended for use by adental practitioner ordental laboratory staff fordesigning the patientspecific component of atwo-piece, one-piece orhybrid dental implantabutment. The single ormulti-unit abutmentdesign is intended to beused by the manufacturerof an endosseous dentalimplant abutment tocreate the final device.
TechnologicalCharacteristics	Proposed Device:InterActiveSMARTBase Abutments(K181359)	Primary Predicate:InterActive EngagingAbutments(K143011)	Reference Device:InterActive Non-EngagingAbutments (K130572)	Reference Device: SironaDental CAD/CAM-System(K111421)	Reference Device:3Shape AbutmentDesigner™ Software(K151455)
	achieved and with appropriateocclusal loading.Narrow Diameter (3.2, 3.3mm)Implants: Indicated for single-tooth replacement of mandibularcentral and lateral incisors andmaxillary lateral incisors. Alsoindicated for multiple toothreplacements or denturestabilization.
Compatibility	InterActive SMARTBaseabutments are compatible at theimplant level with InterActive(3.0mm and 3.4mm Platform)and SwishActive (3.0mm and3.4mm Platform) systemimplants.	InterActive and SwishActiveimplants are prostheticallycompatible with InterActive 3.0and 3.4mm abutments andNobel Biocare conicalconnection NobelActive™ NP(Narrow Platform – 3.0mmdiameter) and NobelActive™RP (Regular Platform - 3.4mmdiameter)abutments. InterActive 3.0 and3.4mm abutments areprosthetically compatible withNobel Biocare conicalconnection NobelActive™ NP(Narrow Platform- 3.0mmdiameter) and NobelActive™RP (Regular Platform - 3.4mmdiameter) (3.5-5.0mmD, 8.5-18mmLength) implants.	InterActive and SwishPlus2implants are prostheticallycompatible with InterActive3.0 and 3.4mm abutments andNobel Biocare conicalconnection NobelActive™ NP(Narrow Platform - 3.0mmdiameter) and NobelActive™RP (Regular Platform –3.4mm diameter)abutments. InterActive 3.0and 3.4mm abutments areprosthetically compatible withNobel Biocare conicalconnection NobelActive™ NP(Narrow Platform- 3.0mmdiameter) and NobelActive™RP (Regular Platform -3.4mm diameter) (3.5-5.0mmD, 8.5-18mmLength)implants.	The InCoris mesostructure andTiBase two-piece abutment iscompatible with the followingimplant systems: NobelBiocare Replace (K020646),Nobel Biocare Branemark(K022562), Friadent Xive(K013867), Biomet 3iOsseotite (K980549), AstraTech Osseospeed (K091239),Zimmer Tapered Screw-Vent(K061410), StraumannSynocta (K061176),Straumann Bone Level(K053088), Biomet 3i Certain(K014235), Nobel BiocareActive (K071370).	N/A
TechnologicalCharacteristics	Proposed Device:InterActiveSMARTBase Abutments(K181359)	Primary Predicate:InterActive EngagingAbutments(K143011)	Reference Device:InterActive Non-EngagingAbutments (K130572)	Reference Device: SironaDental CAD/CAM-System(K111421)	Reference Device:3Shape AbutmentDesigner™ Software(K151455)
GeneralDesign	Abutment body consisting of atitanium base and supplied witha fixation screw. The bases areprovided with straight, angled,and modified zirconia tops forpatient specific devices. Thedevices are also providedwithout a zirconia top and asuperstructure or hybrid crownor bridge can be milled to fit thebases intended to bemanufactured at Implant DirectManufacturing facility.	Abutment body consisting of atitanium base and supplied witha fixation screw. The bases areprovided with straight, angled,or a modified top intended to bemanufactured at Implant DirectManufacturing facility.	Abutment body consisting of atitanium base and suppliedwith a fixation screw. Thebases are provided without arestoration.	The TiBase is apremanufactured prostheticcomponent directly connectedto endosseous dental implantswith a screw and is intendedfor use as an aid in prostheticrehabilitation.	N/A
AbutmentAngle	0° to 30°	0° to 30°	0° to 30°	0° to 20°	N/A
Restoration	Single Unit, Multi-Unit	Single Unit, Multi-Unit	Multi-Unit	Single Unit, Multi-Unit	N/A
Post Height	Single Unit - Minimum 4 mmMulti-Unit - Minimum 4 mm	Single Unit - Minimum 4 mmMulti-Unit - Minimum 4 mm	Minimum of 4mm heightrequired	Minimum 4mm	N/A
Anti-RotationFeature	Single Unit - One FlatMulti-Unit - One Flat	Single Unit - Three VerticalGrooves at 120°Multi-Unit - One Anti-RotationKey	Multi-Unit - One Flat	Single anti-rotation feature	N/A
ProsthesisAttachment	Screw Retained	Screw or Cement Retained	Acrylic	Screw or CementRetained	N/A
Screw Thread	M1.6, M2	M1.6, M2	M1.6, M2	M1.6, M2(NobelActive)	N/A
TechnologicalCharacteristics	Proposed Device:InterActiveSMARTBase Abutments(K181359)	Primary Predicate:InterActive EngagingAbutments(K143011)	Reference Device:InterActive Non-EngagingAbutments (K130572)	Reference Device: SironaDental CAD/CAM-System(K111421)	Reference Device:3Shape AbutmentDesigner™ Software(K151455)
InterfacePlatform	3.0mm and 3.4mm Platform	3.0mm and 3.4mm Platform	3.0mm and 3.4mm Platform	NobelActive, NP and RP	N/A
InterfaceConnection	Engaging and Non-EngagingInternal Hex Conical connection	Engaging and Non-EngagingInternal Hex Conicalconnection	Non-Engaging	Engaging and Non-EngagingInternal Hex Conicalconnection	N/A
ImplantCompatibility	InterActive 3.0mm and 3.4mm	InterActive 3.0mm and 3.4mmand NobelActive NP and RP	InterActive 3.0mm and 3.4mmand NobelActive NP and RP	NobelActive NP and RP	N/A
AbutmentMaterial	Titanium & Zirconia	Titanium & Zirconia	Titanium	Tibase - Titanium 6AL4V,Cercon HT	N/A
AbutmentSurfaceTreatment	Abutments are titanium anodizedgold and pink (grooves aremachined for cement adhesion).	Abutments are anodized gold(grooves are machined forcement adhesion).	None. (grooves are machinedfor acrylic adhesion)	Cemented surfaces are blastedwith aluminum oxide.	N/A
Cement(Adhesive)	EMBRACE	EMBRACE	Acrylic	Panavia F2.0	N/A
ScrewMaterial	Titanium	Titanium	Titanium	Titanium	N/A
Sterility	Non-Sterile	Non-Sterile	Non-Sterile	Non-Sterile	N/A
SterilizationMethod	Steam Sterilization	Steam Sterilization	Steam Sterilization	Steam Sterilization	N/A
Use	Single-Use	Single-Use	Single-Use	Single-Use	N/A
TechnologicalCharacteristics	Proposed Device:InterActiveSMARTBase Abutments(K181359)	Primary Predicate:InterActive EngagingAbutments(K143011)	Reference Device:InterActive Non-EngagingAbutments (K130572)	Reference Device: SironaDental CAD/CAM-System(K111421)	Reference Device:3Shape AbutmentDesigner™ Software(K151455)
Packaging	Inside a vial sealed with a cap	Inside a vial sealed with a cap	Inside a vial sealed with a cap	Unknown	N/A

6. TECHNOLOGICAL CHARACTERISTICS COMPARISON

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The proposed device has the same intended use and similar technological characteristics to that of the predicate device and reference devices. The proposed SMARTBase devices are different from the primary predicate devices, K143011, by 1) having a different titanium anodize color, 2) having a different anti-rotation feature for the zirconia top, 3) using a digital workflow, and 4) having a minimum zirconia wall thickness that is 0.2mm larger. The proposed devices are different from the reference devices (K130572 and K111421) by 1) having a titanium anodize color, 2) having a different anti-rotation feature for the zirconia top, and 3) having a different cement.

The anodize process used for the proposed SMARTBase is the same as the primary predicate devices (K143011). The reference devices (K130572) are not processed through a titanium anodize procedure. The proposed titanium anodizing colors only changes the oxide layer thickness. The thickness of the oxide layer determines the color of the device. The anti-rotation feature is used to orient the zirconia top to the correct position. The antirotation feature in the SMARTBase is a flat rather than three vertical grooves as in the primary predicate device. The reference device (K130572) has the same type of antirotation feature as the proposed device. The reference device (K111421) has a machined titanium key that fits into an internal keyway in the zirconia to prevent rotation. The proposed device uses different cement for attachment from those used in the references devices. The proposed device uses 3Shape Abutment Designer Software, while the reference device (K111421) uses Sirona Dental CAD/CAM Software. Both software (3Shape and Sirona Dental CAD/CAM Software) provide a digital design output file that is used for fabricating the finished device. The proposed devices include the two-piece abutments as a physical output as well as a validated manufacture process. The reference device 3Shape Abutment Designer Software does not provide any physical parts that come into contact with patient and only provides the digital design as an accessory to the physical dental abutment system. The differences in the indications for use of the proposed device and the reference device (3Shape Abutment Designer Software) are related to a lack of a physical output from the reference device.

Overall, any noted differences have been evaluated and supported by non-clinical testing and therefore do not affect substantial equivalence.

7. NON-CLINICAL TESTING

Non-clinical testing was performed on the proposed device. Testing include mechanical strength, biocompatibility, cleaning and steam sterilization validation, and software verification & validation. Successful test results indicated that the subject device will perform as intended and support the substantial equivalence of the InterActive SMARTBase abutments.

Mechanical testing

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Fatigue testing was performed on worst-case configuration of proposed devices per o ISO 14801. Results indicated that the proposed SMARTBase abutments successfully completed endurance testing and was equivalent to the predicate devices.
Screw Torque testing was performed on worst case drivers. Results indicated the o drivers met the specified torque as the predicate device.
Biocompatibility testing
- o Biological evaluation was conducted according to ISO 10993-1. Cytotoxicity testing per ISO 10993-5 was conducted on the finished devices. Results indicate that the devices met biocompatibility requirements for its intended use.
Software Verification & Validation

Software verification and validation testing was provided for the subject abutment design library to demonstrate use with 3Shape Abutment Designer™ Software (K151455). Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the zirconia top component outside of design limitations, including screenshots under user verification testing. In addition, the encrypted abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified within the abutment design library.

Steam Sterilization Validation
- The proposed devices are provided non-sterile and intended to be steam sterilized O by the end user. Steam sterilization validation was performed on the primary predicate device per ISO 17665-1 and ISO 17665-2. The proposed devices have the same materials, same manufacturing processes, and same sterilization parameters as the predicate devices. The proposed devices are expected to meet the same sterilization requirements and thus no additional testing is needed.

8. CLINICAL TESTING

Clinical performance testing has not been performed. Clinical testing is not needed to support substantial equivalence.

9. CONCLUSION

The intended use, the indications for use, and technological characteristics of the proposed devices are similar to those of the predicate devices. Any noted differences between the proposed and predicate devices do not affect the intended use and have been addressed by the performance data. Based on the intended use, technological characteristics, and

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applicable performance data included in this submission, the proposed devices have been shown to be substantially equivalent to the predicate devices.

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.)