The SMARTbase Abutment System is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or fully edentulous patient. The SMARTbase Abutment System is intended for use in the mandible or maxilla in support of single or multiple unit restorations.

The SMARTbase Abutment System integrates multiple components for use in both a traditional and digital dentistry workflow: scan files from Intra-oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTbase Abutment System consists of two major parts: the titanium base and zirconia top components make up a two-piece abutment.

SMARTbase abutment for narrow (3.2mmD) Legacy implants: Indicated for single-tooth replacement of mandbular central and lateral incisors and maxillary lateral incisors.
SMARTbase abutment for short (8mm) 3.7mmD Legacy implants: Indicated for tooth replacement of mandbular and maxillary central and lateral incisors.
SMARTbase abutment for narrow diameter (3.2. 3.3mm) InterActive 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 SMARTbase Abutment System is a two-piece engaging and non-engaging dental implant abutment comprised of a titanium base and a zirconia top (which can be supplied with the base or acquired separately by the customer). There are three device lines offered in the SMARTbase Abutment System: Legacy™ SMARTbase Abutment, InterActive™ SMARTbase Abutment, and SMARTbase Cylinder.

The abutments are offered in three widths (narrow, regular, and wide), platform diameters of 3.0mm, 3.5mm, 4.5mm and 5.7mm for Legacy™ and 3.0mm, 3.4mm for InterActive™, and collar (titanium base) heights of 0.25, 1.0, and 2.0 mm in order to accommodate different patient anatomies. The SMARTbase Cylinder is a two-piece non-engaging dental implant and multi-unit abutment cylinder comprised of a titanium base and a zirconia top (which can be supplied with the base or acquired separately by the customer). The SMARTbase Cylinder is offered in two heights 9.0mm (that can be shortened to 4.0mm) and 4.0mm and in one width, platform diameters and collar (titanium base) height in order to accommodate different patient anatomies.

The subject device is supplied with fixation screws that function as an extension of the implant or multi-unit abutment to which the SMARTbase Abutment or SMARTbase Cylinder is secured and is used with several accessories in digital workflows to fabricate the patient-specific restorations, including scan adapters, implant analogs, and off-axis tools.

The available design options for the zirconia top components to be provided either as a superstructure (to then receive a separate crown or bridge) or hybrid abutment-crown. There are three workflow options for fabricating the zirconia top component which fits the titanium abutment base:

(1) end user creation of a press-ceramic material by conventional wax-up technique,

(2) Implant Direct design and milling of zirconia in stock sizes using ceramic material of ZirCAD Prime (K142233) and provision of same to the end user, and

(3) digital workflow using 3Shape or Exocad software where CAD design and milling of the superstructure or hybrid crown component is done at the end user's dental laboratory/office; the CAD design requires loading of Implant Direct's abutment design library to the 3Shape or Exocad software to design the superstructure or hybrid crown component within the established design limitations and specifications. The digital workflow includes use of the following products (not subject devices of this submission):

Ceramic material: ZirCAD Prime (K142233) .
. Cement: Maxcem Elite Self-Etch/Self-Adhesive Resin Cement (K060469)
. Composite: Kerr Harmonized (K151332)
Intra oral scanners: Medit Scanner, ITero Scanner Trios Scanner, CareStream . Scanner
Abutment design software: 3Shape Abutment Designer™ Software (K151455) and • Exocad AbutmentCAD Software (K193352)
. Milling machine: Wieland-Zenotec Select, Zenotec CAM, iCAM V5, and imes icore

AI/ML Overview

This document describes a premarket notification for the "SMARTbase Abutment System," a dental implant abutment. The document focuses on demonstrating that the new device is substantially equivalent to existing predicate devices through various performance tests.

Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a single, clear format for each test. Instead, it states that "The test results support that the Subject Device met the performance specifications as intended." and "The difference does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantial equivalent."

However, we can infer the types of performance tests and the general acceptance (i.e., compliance) from the "x. Performance Testing Data" section.

Acceptance Criteria (Inferred Standard Compliance)	Reported Device Performance (Implied)
Fatigue Resistance (according to ISO 14801 and FDA Guidance Document: "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments")	The device met performance specifications as intended, demonstrating substantial equivalence.
Magnetic Resonance Compatibility (according to ASTM F2052, ASTM F2213, ASTM F2119, and ASTM F2182)	The device met performance specifications as intended, demonstrating substantial equivalence.
Biocompatibility (according to ISO 10993-1)	The device is biocompatible as per the standard.
Steam Sterilization Validation (according to ISO 17665-1)	Sterilization process was validated.
Shipping Validation (according to ASTM D4169)	Shipping validation was performed.
Software Verification & Validation (Abutment Design Library) (demonstrating use with 3Shape Abutment Designer Software and Exocad AbutmentCAD software)	Demonstrated that design restrictions prevent creation of components outside allowable limitations; established design limitations are locked and unmodifiable.

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

Sample Size for Test Set: The document does not specify the exact sample sizes used for each of the performance tests (e.g., number of abutments subjected to fatigue testing).
Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Given that this is a premarket notification for regulatory clearance, the testing would generally be conducted by the manufacturer or a contract research organization on manufactured devices, following established protocols. It is non-clinical testing, meaning it's not performed on patients.

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

This question is not applicable as the document describes non-clinical performance testing for a medical device (dental abutment), not studies involving expert evaluation of diagnostic outputs or ground truth for AI algorithms. The "ground truth" here is defined by engineering standards (e.g., ISO, ASTM).

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as #3. Adjudication methods (like 2+1) are typically used for establishing ground truth in clinical or diagnostic studies involving human interpretation or pathology.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This question is not applicable. The document describes non-clinical performance testing of a physical dental abutment and associated design software. It does not involve human readers, cases, or AI assistance in a diagnostic context.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

For the software component:

Standalone Performance: Yes, standalone software verification and validation testing was performed for the abutment design library. This testing demonstrated that the software's inherent design restrictions and specifications for creating the top half of the two-piece abutment prevent designs outside allowable limitations and that the design limitations are locked and cannot be modified. This is essentially an "algorithm only" test to ensure the software functions as designed within its specified parameters.

7. The Type of Ground Truth Used

For Physical Device Performance (Fatigue, MR Compatibility, Biocompatibility, Sterilization, Shipping): The ground truth is based on established international and national standards (e.g., ISO 14801, ISO 10993-1, ISO 17665-1, ASTM F2052, ASTM D4169). Compliance with these standards serves as the "ground truth" for acceptable mechanical, safety, and operational performance.
For Software Verification & Validation: The ground truth is the defined design limitations and specifications established by the manufacturer for the abutment components. The software's ability to enforce these limitations (preventing designs outside them and locking specifications) constitutes meeting this "ground truth."

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical dental abutment and associated design software. It is not an AI/ML algorithm that requires a "training set" in the conventional sense for learning patterns from data to make predictions or classifications. The "training" for the software is its programmed adherence to design rules and specifications.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons as #8. There is no training set mentioned for an AI/ML model. The software's functional parameters are established through engineering design and specifications.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K223535

Trade/Device Name: SMARTbase Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: May 19, 2023 Received: May 22, 2023

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. 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 mediation-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) K223535

Device Name

SMARTbase Abutment System

Indications for Use (Describe)

SMARTbase abutment for narrow (3.2mmD) Legacy implants: Indicated for single-tooth replacement of mandbular central and lateral incisors and maxillary lateral incisors.
SMARTbase abutment for short (8mm) 3.7mmD Legacy implants: Indicated for tooth replacement of mandbular and maxillary central and lateral incisors.
SMARTbase abutment for narrow diameter (3.2. 3.3mm) InterActive 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.

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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Image /page/3/Picture/0 description: The image shows the logo for Implant Direct, with the words "IMPLANT DIRECT" in large, gray, sans-serif font. To the left of the text is a graphic of a screw-like object with an orange top. Below the logo, the words "510(k) Summary" are written in a large, bold, black font.

K223535

i. Submitter Information

Submitter:	Implant Direct SybronManufacturing LLC3050 E. Hillcrest DriveThousand Oaks, CA91362, USA
------------	----------------------------------------------------------------------------------------------------------

Contact Person:

E-Mail: Telephone Number: Prepared By: Date Prepared

Reina Choi, Senior Regulatory Affairs Manager Reina.choi@envistaco.com (818) 307-3132 Reina Choi 16 June 2023

ii.Device Name

Proprietary name:	SMARTbase Abutment System
Manufacturer:	Implant Direct Sybron Manufacturing LLC
Common Name:	Dental Abutment
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	21 CFR§872.3630
Device Class:	II
Product Code:	NHA (Primary), PNP (Secondary)

iii. Predicate Devices

Primary Predicate Device

Propriety Name:	Legacy™ SMARTBase Abutments (K191458)
Manufacturer:	Implant Direct Sybron Manufacturing LLC
Common Name:	Dental Abutment
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	21 CFR§872.3630
Device Class:	Class II
Product Code:	NHA, PNP

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Reference Device #1

Propriety Name:	InterActve™ SMARTBase Abutment(K181359) Manufacturer: Implant Direct Sybron Manufacturing LLC
Common Name:	Dental Abutment
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	21 CFR§872.3630
Device Class:	Class II
Product Code:	NHA, PNP

Reference Device #2

Proprietary Name:	3Shape Abutment Designer™ Software (K151455)
Manufacturer:	3Shape A/S
Common Name:	Dental Abutment Design Software for Dental Laboratory
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	21 CFR§872.3630
Regulatory Class:	II
Product Code:	PNP

Reference Device #3

Proprietary Name:	Spectrum System (K061319)
Manufacturer:	Implant Direct Sybron Manufacturing LLC
Common Name:	Dental Abutment
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	21 CFR§872.3630
Regulatory Class:	II
Product Code:	NHA

Reference Device #4 Spectrum-System Abutments 2008 (K081101) Proprietary Name: Manufacturer: Implant Direct Sybron Manufacturing LLC Common Name: Dental Abutment Endosseous Dental Implant Abutment Classification Name: Regulation Number: 21 CFR§872.3630 Regulatory Class: ll Product Code: NHA

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Reference Device #5
Proprietary Name:	ExocadAbutmentCAD (K193352)
Manufacturer:	Exocad GmbH
Common Name:	Dental Abutment Design Software for DentalLaboratory
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	21 CFR§872.3630
Regulatory Class:	II
Product Code:	PNP

Reference Device #6

Proprietary Name:	DESS Dental Smart Solutions (K222288)
Manufacturer:	Terrats Medical SL
Common Name:	Dental Abutment
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	21 CFR§872.3630
Regulatory Class:	II
Product Code:	NHA

Reference Device #7

Proprietary Name:	Titanium Abutment Blank Nobel Biocare N1 TCC (K223677)
Manufacturer:	Nobel Biocare AB
Common Name:	Dental Abutment
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	21 CFR§872.3630
Regulatory Class:	II
Product Code:	NHA, PNP

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iv. Device Description

	LegacyTMSMARTbaseAbutment	InterActiveTMSMARTbaseAbutment	SMARTbaseCylinders
Platform Diameter	3.0mm, 3.5mm,4.5mm, and5.7mm	3.0mm and 3.4mm	5.0mm
Titanium BaseHeight	4mm and 6.6mm	4mm and 6.6mm	4mm and 9mm
Coronal Width	Narrow, Regular,Wide	Extra-narrow,Narrow, Regular,and Wide	N/A
Abutment CollarHeight*	0.25, 1, 2mm	1 and 2mm	0.25mm
AbutmentAngulation	0 to 30 degrees	0 to 30 degrees	0 to 30 degrees
Abutment PostHeight	4mm minimum	4mm minimum	4mm minimum
Zirconia WallThickness	Single Unit:Wall thickness	Single Unit:Wall thickness	Single Unit:Wall thickness

Table 0-1 Design Specifications for SMARTbase Abutment System

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circular: 0.9mmminimum	circular: 0.9mmminimum	circular: 0.9mmminimum
Multiple Unit: 2mm	Multiple Unit: 2mm	Multiple Unit: 2mm

the "Abutment Collar Height" values are provided by the titanium base component for the two-piece SMARTbase Abutment System.

(1) end user creation of a press-ceramic material by conventional wax-up technique,

(2) Implant Direct design and milling of zirconia in stock sizes using ceramic material of ZirCAD Prime (K142233) and provision of same to the end user, and

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Ceramic material: ZirCAD Prime (K142233) .
. Cement: Maxcem Elite Self-Etch/Self-Adhesive Resin Cement (K060469)
. Composite: Kerr Harmonized (K151332)
Intra oral scanners: Medit Scanner, ITero Scanner Trios Scanner, CareStream . Scanner
Abutment design software: 3Shape Abutment Designer™ Software (K151455) and • Exocad AbutmentCAD Software (K193352)
. Milling machine: Wieland-Zenotec Select, Zenotec CAM, iCAM V5, and imes icore

ln compliance with the FDA Guidance Document titled, "Bundling Multiple Devices or Multiple Indications in a Single Submission," issued June 22, 2007, Implant Direct has prepared a single submission for the SMARTbase Abutment System as the supporting data is relevant to the SMARTbase Abutment System as a whole, and one review group will be involved.

v. Principle of Operation / Mechanism of Action

The abutment is mechanically connected to an endosseous implant via screw or cement for tooth replacement to restore chewing function. The abutments allow for patientspecific designs through conventional and digital restoration materials and methods. The final restorations are designed and produced under the direction of a clinical professional and are based on requirements provided to Implant Direct or the preferred laboratory in digital or stone model form. The restoration (crown) is designed to fit on top of the SMARTbase abutment using off-the-shelf 3Shape software (K151455) or Exocad software (K193352).

vi. Compatible Devices and Accessories

The SMARTbase Abutment System is intended to be used with the following previously cleared or exempt accessories/devices from Implant Direct below.

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Table 0-2 – Compatible Implants and Auxiliary Accessories for SMARTbase

Product Name	ProductCode	Regulation #	Device Class	510(k)Clearance
InterActive™, SwishActive™ and	DZE	872.3640		K130572
simply InterActive™ Implants				K143011
Simply Iconic™ Implants	DZE	872.3640	==============================================================================================================================================================================	K210553
InterActive™ Abutments	NHA	872.3630	==============================================================================================================================================================================	K130572
ScrewIndirect™ Implants	DZE	873.3640	==============================================================================================================================================================================	K080633
Legacy™ Implants	DZE	873.3640	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	K192221
				K073033
Legacy™ MUA	NHA	872.3630		K090234
				K060063
				K061319
InterActive™ MUA	INHA	872.3630		K153509

Fixation Screw	NHA	873.3630		K181359
				K192458
Scan Adapter	NDP	872.3980		EXEMPT
Castable Coping	NDP	872.3980		EXEMPT
Implant Analog	NDP	872.3980		EXEMPT
Off-axis Tools	NDP	872.3980		EXEMPT

Abutment System

vii. Patient Contacting Components

Following the assessment set forth in ISO 10993-1:2018 Biological Evaluation of Medical Devices, Annex A, it was determined that the devices in scope of this submission do contain patient contacting components. The patient contacting components have direct patient contact components for a permanent duration of time (>30 days).

Table 0-3 – Patient Contacting Materials

Product Name	Material Description	Colorant
SMARTbase AbutmentSystem	Titanium 6AL4V ELI (ASTM F136 / ISO 5832-3) andZirconia	N/A
Fixation Screw	Titanium	N/A

viii. Indications for Use

The SMARTbase Abutment System is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially and fully edentulous patient. The SMARTbase Abutment System is intended for use in the mandible or maxilla

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in support of single or multiple unit restorations.

The SMARTbase Abutment System integrates multiple components for use in both a traditional and digital dentistry workflow: scan files from Intra-oral Scanners and lab scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTbase Abutment System consists of two major parts: the titanium base and zirconia top components make up a two-piece abutment.

SMARTbase abutment for narrow (3.2mmD) Legacy implants: Indicated for single-tooth . replacement of mandibular central and lateral incisors and maxillary lateral incisors.
SMARTbase abutment for short (8mm) 3.7mmD Legacy implants: Indicated for tooth . replacement of mandibular and maxillary central and lateral incisors.
SMARTbase abutment for narrow diameter (3.2. 3.3mm) InterActive 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.

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ix. Summary of Substantial Equivalence

The similarities and differences between the Subject Device the SMARTbase Abutment System and the Predicate Device/Reference Devices as described in Table 3-0 are as follows:

The Intended Use and Principle of Operation of the Subject Device and the Primary . Predicate are the same. Both devices are used for supporting tooth replacements to restore chewing function.
The Indications for Use of the Subject Device and the Primary Predicate is the . similar except the subject device has a stand-alone compatibility section in the Instructions for Use. Both devices are prosthetic abutments that are directly connected to endosseous dental implants as an aid in prosthetic rehabilitation.
· The technological characteristics of the Subject device and the Primary Predicate are same. Both devices are cement or screw retained 2-piece abutments that are composed of titanium base (made from titanium alloy Ti6AI4V ELI according to ASTM F136 and ISO 5832-3) with gold and pink anodization and zirconia top components to make up a 2-piece abutment.
· Both Subject Device and Reference Device#1 can be fabricated from conventional and digital workflows for single or multi-unit restoration with same modification parameters.
Both Subject Device and Primary Predicate Device (Legacy Engagement . Abutment) have same design specifications: abutment collar height: 0.25mm, 1mm, and 2mm and 300 maximum angulation, and minimum 4mm post height.
. The approach for non-clinical performance testing and software verification & validation is the same for the Subject Device and the Primary Predicate. Testing was conducted to confirm that the technological differences between the devices do not raise different questions of substantial equivalence. The test results support that the Subject Device met the performance specifications as intended.

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There are no major differences however there are minor differences between the subject device and predicate devices including:

Workflow components and specific limitations are described in Description, . Compatibility, and Warnings sections of the IFU. This does not raise new questions of substantial equivalence.
The Subject Device has additional device line SMARTbase Cylinder that is . compatible with implant and multi-unit abutments. This has been demonstrated by fatigue testing and thus does not raise new question of substantial equivalence.
The Subject Device integrates different ceramic and cement materials, additional . abutment design software, scanners, and milling machines to fabricate zirconia top component. This does not raise different questions of substantial equivalence as demonstrated by non-clinical performance testing and software verification & validation testing that the device can perform as intended.

Conclusion:

Based on a comparison of intended use, indications for use, technological characteristics, principle of operation, features, and performance data, the SMARTbase Abutment system is deemed to be substantially equivalent to the Predicate/Reference Devices as it satisfies all criteria of substantial equivalence and does not raise new concerns regarding substantial equivalence: Indications for Use, Technological Characteristics and Performance Data. The difference does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantial equivalent.

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Table 0-4: SMARTbase Abutment System Comparison Table
DescriptiveInformation	Subject DeviceSMARTbaseAbutmentSystem(K223535)	PrimaryPredicateLegacy™EngagingSMARTBaseAbutments(K191458)	ReferenceDevice#1InterActive™SMARTBaseAbutment(K181359)	ReferenceDevice#23Shape AbutmentDesigner™Software(K151455)	ReferenceDevice#3SpectrumSystem(K061319)	ReferenceDevice#4Spectrum-SystemAbutments 2008(K081101)	ReferenceDevice #5ExocadAbutmentCAD(K193352)	ReferenceDevice #6DESS DentalSmartSolutions(K222288)	ReferenceDevice #7TitaniumAbutmentBlank NobelBiocare N1TCC (K223677)	Comparison
Manufacturer	Implant Direct	Implant Direct	Implant Direct	3Shape A/S	Implant Direct	Implant Direct	Exocad GmbH	Terrats MedicalSL	Nobel Biocare	Same
PictorialRepresentation	Image: [abutments]	Image: [abutment]	Image: [abutment]	N/A	Image: [abutments]	Image: [abutments]	N/A	Image: [abutment]	Image: [abutment]	N/A
Regulatory Classification
Regulation #	21 CFR872.3630	21 CFR 872.3630	21 CFR 872.3630	21 CFR 872.3630	21 CFR872.3630	21 CFR 872.3630	21 CFR872.3630	21 CFR872.3630	21 CFR872.3630	Same
Regulation Title	Endosseousdental implantabutment	Endosseousdental implantabutment	Endosseousdental implantabutment	Endosseous dentalimplant abutment	Endosseousdental implantabutment	Endosseousdental implantabutment	Endosseousdental implantabutment	Endosseousdental implantabutment	EndosseousDental ImplantAbutment	Same
RegulationClass	II	II	II	II	II	II	II	II	II	Same
Product Code	NHA, PNP	NHA, PNP	NHA, PNP	PNP	NHA	NHA	PNP	NHA	NHA, PNP	Same
Indications for Use/Intended Use
Indications forUse	TheSMARTbaseAbutmentSystem isdesigned to beused in supportof a dentalimplant(s) toprovide supportfor prostheticrestorations in apartially or fullyedentulouspatient.	The Legacy™SMARTbaseAbutment systemis designed to beused in supportof a dentalimplant(s) toprovide supportfor prostheticrestorations in apartiallyedentulouspatient.	InterActive/SwishActive ImplantSystem consists oftwo-piece implantsfor one- stage ortwo-stage surgicalprocedures. Theseimplants areintended for use inpartially and fullyedentulous upperand lower jaws insupport of singleor multiple unit	The 3ShapeAbutment DesignerSoftware isintended as an aidto the restoration ofchewing function inpartially or fullyedentulousmandibles andmaxillae. The3Shape AbutmentDesigner Softwareis intended for useby a dental	The SpectraDental ImplantSystem consistsof one-piece ortwo-pieceimplants forsingle-stage ortwo- stagesurgicalprocedures thatare intended foruse in partiallyor fullyedentulous	Spectra-SystemAbutments aredesigned to beused in support ofa dental implant(s)to provide supportfor prostheticrestorations suchas crowns,bridges,overdentures orcustom prostheticfabrications in apartially or	TheAbutmentCADmodule isintended as anaid to therestoration ofchewing functionin partially orfully edentulousmandibles andmaxillae.AbutmentCAD isa softwaredevice intended	DESS DentalSmartSolutionsabutments areintended to beused inconjunctionwithendosseousdental implantsin the maxillaryor mandibulararch to providesupport for	TitaniumAbutment BlankNobel BiocareN1 ™ TCC is apremanufacturedprostheticcomponentdirectlyconnected to anendosseousdental implantand is indicatedfor use as an aidin prosthetic	Same - Proposed,predicate, andreference devicesare indicated foruse with dentalimplants to providesupport for singleunit or multiple unitprostheticrestorations forpartially or fullyedentulous patientsin the mandible ormaxilla.
DescriptiveInformation	Subject DeviceSMARTbaseAbutmentSystem(K223535)	PrimaryPredicateLegacy™EngagingSMARTBaseAbutments(K191458)	ReferenceDevice#1InterActive™SMARTBaseAbutment(K181359)	ReferenceDevice#23Shape AbutmentDesigner™Software(K151455)	ReferenceDevice#3SpectrumSystem(K061319)	ReferenceDevice#4Spectrum-SystemAbutments 2008(K081101)	ReferenceDevice #5ExocadAbutmentCAD(K193352)	ReferenceDevice #6DESS DentalSmartSolutions(K222288)	ReferenceDevice #7TitaniumAbutmentBlank NobelBiocare N1TCC (K223677)	Comparison
	SMARTbaseAbutmentSystem isintended for usein the mandibleor maxilla insupport of singleor multiple unitrestorations.TheSMARTbaseAbutmentSystem	LegacySMARTBaseengagingabutments areintended for usein the mandibleor maxilla insupport of singleunit restorations.The LegacySMARTBaseAbutment systemintegratesmultiple	restorations andterminal orintermediateSMARTBasesupport for fixedbridgework. Thesystem integratesmultiplecomponents of thedigital dentistryworkflow: scanfiles from Intra-Oral Scanners,CAD software,	practitioner ordental laboratorystaff for designingthe patient specificcomponent of atwo-piece, one-piece, or hybriddental implantabutment. Thesingle or multi-unitabutment design isintended to be usedby themanufacturer of an	mandibles andmaxillae, insupport of singleor multiple-unitrestorations andterminal orintermediateabutmentsupport for fixedbridgework.They may beplaced inimmediatefunction if initial	completelyedentulouspatient. Spectra-SystemAbutments areintended for use inthe mandible ormaxilla.Prostheses can bescrew or cementretained to theabutment	to be used bytrainedprofessionals indental practicesor dentallaboratories forthe design ofpatient specificimplant borneprosthetics suchas one-pieceabutments, two-piece/hybridabutments,	prostheticrestorations.All digitallydesignedcustomabutments foruse with TiBaseabutments orPre-milledBlankabutments areto be sent to aTerrats Medical	rehabilitation forsingle units andmultiple units ofup to three unitsThe systemintegratesmultiplecomponents ofthe digitaldentistryworkflow scanfiles from Intra-Oral Scanners,CAD software,	Abutments arecompatible with thesame implantshaving the sameplatform sizes andthread sizes.The restorationsare made usingeither aconventional ordigital workflow.
	integratesmultiplecomponents foruse in both atraditional anddigital dentistryworkflow: scanfiles from Intra-oral Scannersand labscanners, CADsoftware, CAMsoftware,ceramicmaterial, millingmachine andassociatedtooling andaccessories. TheSMARTbaseAbutmentSystem consistsof two majorparts: the	components foruse in both atraditional &digital dentistryworkflow: scanfiles from Intra-oral Scanners &lab scanners,CAD software,CAM software,ceramic material,milling machineand associatedtooling andaccessories. TheLegacySMARTbasesystem consist oftwo major parts:the titanium baseand zirconia topcomponentsmake up a two-piece abutment.	CAM software,ceramic material,milling machineand associatedtooling andaccessories. TheSMARTBaseAbutments consistof two major parts.Specifically, thetitanium base andzirconia topcomponents makeup a two- pieceabutment.Implants can beindicated forimmediate loadingwhen goodprimary stabilityhas beenachieved and withappropriateocclusal loading.	endosseous dentalimplant abutment tocreate the finaldevice.	implant stabilitycan beestablished. TheScrew Indirectimplant isindicated for thesupport andretention of baroverdentures oras a terminal orintermediaryattachment forscrew-retainedfixedbridgework. It isindicated forimmediatefunctionalloading whenfour or moreimplants aresplinted togetherin theedentulous		single or multi-unit screw-retainedrestorations.The designresult isintended to beused by themanufacturer ofan endosseousdental implantabutment tocreate the finaldevice.	validatedmilling centerformanufacture.	CAM software,restorationmaterial blanks,milling machineand associatedtooling andaccessories
DescriptiveInformation	Subject DeviceSMARTbaseAbutmentSystem(K223535)	PrimaryPredicateLegacy™EngagingSMARTBaseAbutments(K191458)	ReferenceDevice#1InterActive™SMARTBaseAbutment(K181359)	ReferenceDevice#23Shape AbutmentDesigner™Software(K151455)	ReferenceDevice#3SpectrumSystem(K061319)	ReferenceDevice#4Spectrum-SystemAbutments 2008(K081101)	ReferenceDevice #5ExocadAbutmentCAD(K193352)	ReferenceDevice #6DESS DentalSmartSolutions(K222288)	ReferenceDevice #7TitaniumAbutmentBlank NobelBiocare N1TCC (K223677)	Comparison
	titanium baseand zirconia topcomponentsmake up a two-piece abutment.•SMARTbaseabutment fornarrow(3.2mmD)Legacy implants:Indicated forsingle-toothreplacement ofmandibularcentral andlateral incisorsand maxillarylateral incisors.•SMARTbaseabutment forshort (8mm)3.7mmD Legacyimplants:Indicated fortoothreplacement ofmandibular andmaxillary centraland lateralincisors.•SMARTbaseabutment fornarrow diameter(3.2. 3.3mm)InterActiveimplants:Indicated for	•LegacySMARTbaseabutment fornarrow dimeter(3.2mmD)implants:Indicated forsingle- toothreplacement ofmandibularcentral andlateral incisorsand maxillarylateral incisors.•LegacySMARTbaseabutment forshort (8mm)3.7mmDimplants: Notintended for toothreplacement ofcanines, pre-molars or molars.	•Narrow Diameter(3.2, 3.3mm)Implants:Indicated forsingle-toothreplacement ofmandibular centraland lateral incisorsand maxillarylateral incisors.Also indicated formultiple toothreplacements ordenturestabilization.		upper or lowerjaw. This implantmodel is notindicated for usewith abutments,only with a 2mmextender.
DescriptiveInformation	Subject DeviceSMARTbaseAbutmentSystem(K223535)	PrimaryPredicateLegacy™EngagingSMARTBaseAbutments(K191458)	ReferenceDevice#1InterActive™SMARTBaseAbutment(K181359)	ReferenceDevice#23Shape AbutmentDesigner™Software(K151455)	ReferenceDevice#3SpectrumSystem(K061319)	ReferenceDevice#4Spectrum-SystemAbutments 2008(K081101)	ReferenceDevice #5ExocadAbutmentCAD(K193352)	ReferenceDevice #6DESS DentalSmartSolutions(K222288)	ReferenceDevice #7TitaniumAbutmentBlank NobelBiocare N1TCC (K223677)	Comparison
	single-toothreplacement ofmandibularcentral andlateral incisorsand maxillarylateral incisors.Also indicatedfor multiple toothreplacements ordenturestabilization.
Compatibility	• LegacyTM1:body diameter3.7 – 5.7mm;platformdiameter 3.5,4.5, 5.7mm;implant length8- 16mm,excluding 6mmlength• LegacyTM2, 3,4,simplyLegacy2& 3: bodydiameter3.2 - 7.0mm;platformdiameter 3.0,3.5, 4.5, 5.7mm;implant length 8-16mm, excluding6mm length• InterActive™:body diameter3.2-5.0mm;platform	LegacySMARTBaseengagingabutments arecompatible at theimplant level withLegacy (3.0mm,3.5mm, 4.5mmand 5.7mmplatformdiameter)implants,excluding 6mmlength implants.*Legacy1: bodydiameter 3.7 -5.7mm; platformdiameter 3.5, 4.5,5.7mm; implantlength 8- 16mm,excluding 6mmlength•Legacy2, 3, 4,simplyLegacy2 &3: body diameter	InterActiveSMARTBaseabutments arecompatible at theimplant level withInterActive(3.0mm and3.4mm Platform)and SwishActive(3.0mm and3.4mm Platform)system implants.InterActive: bodydiameter 3.2-5.0mm;platform diameter3.0,3.4mm; implantlength 8- 16mm,excluding 6mmlengthSwishActive:body diameter 3.3-4.8mm; platformdiameter 3.0,	N/A	Screw IndirectImplants (5.0mmPlatform),Legacy andInterActiveMUAs (5.0mmPlatform)	Screw IndirectImplant (5.0mmPlatform), Legacyand InterActiveMUAs (5.0mmPlatform)	N/A	Ankylos C/X,Astra Tech EV,Astra TechOsseoSpeed™3.0,BioHorizons,Biomet 3iCertain®,Biomet 3iOSSEOTITE®,Camlog,DentiumSuperLine,FRIADENTXiVE®,MegaGenAnyRidge,Neodent GrandMorse,NobelActive®,NobelParallelConical,NobelReplace®Trilobe, NobelBrånemarkSystem®,	Narrow Platform(NP)RegularPlatform (RP)N1 TiUltra TCCimplants	Similar; the addedcompatibilityinformation fordevice does notraise any safetyand efficacyquestion as it issupported byfatigue test data.
DescriptiveInformation	Subject DeviceSMARTbaseAbutmentSystem(K223535)	PrimaryPredicateLegacy™EngagingSMARTBaseAbutments(K191458)	ReferenceDevice#1InterActive™SMARTBaseAbutment(K181359)	ReferenceDevice#23Shape AbutmentDesigner™Software(K151455)	ReferenceDevice#3SpectrumSystem(K061319)	ReferenceDevice#4Spectrum-SystemAbutments 2008(K081101)	ReferenceDevice #5ExocadAbutmentCAD(K193352)	ReferenceDevice #6DESS DentalSmartSolutions(K222288)	ReferenceDevice #7TitaniumAbutmentBlank NobelBiocare N1TCC (K223677)	Comparison
	diameter 3.0,3.4mm; implantlength 8- 16mm,excluding 6mmlength•SwishActive™:body diameter3.3-4.8mm;platformdiameter 3.0,3.4mm; implantlength 8- 16mm,excluding 6mmlengthScrewIndirect™:body diameter3.0-5.7mm;platformdiameter 5.0mm;implant length 8-16mm Legacy™Multi-unitAbutment:Abutmentplatformdiameter 5.0mm;InterActive™Multi-unitAbutment:Abutmentplatformdiameter 5.0mm	3.2 - 7.0mm;platform diameter3.0, 3.5, 4.5,5.7mm; implantlength 8- 16mm,excluding 6mmlength	3.4mm; implantlength 8- 16mm,excluding 6mmlength					Osstem TS,StraumannBLX,Straumann®Bone Level,Straumann®Tissue Level,Zimmer Eztetic,Zimmer ScrewVent®/TaperedScrew-Vent®, ZimmerSpline, ZimmerSwissPlus
					Technological Characteristics
InterfacePlatformDiameter	Legacy: 3.0mm,3.5mm, 4.5mm,and 5.7mm	3.0mm, 3.5mm,4.5mm, and5.7mm	3.0mm and 3.4mm	N/A	5.0mm	5.0mm	N/A	Zimmer ScrewVent®/TaperedScrew-Vent® -	NP, RP	Same
DescriptiveInformation	Subject DeviceSMARTbaseAbutmentSystem(K223535)	PrimaryPredicateLegacyTMEngagingSMARTBaseAbutments(K191458)	ReferenceDevice#1InterActive™SMARTBaseAbutment(K181359)	ReferenceDevice#23Shape AbutmentDesigner™Software(K151455)	ReferenceDevice#3SpectrumSystem(K061319)	ReferenceDevice#4Spectrum-SystemAbutments 2008(K081101)	ReferenceDevice #5ExocadAbutmentCAD(K193352)	ReferenceDevice #6DESS DentalSmartSolutions(K22288)	ReferenceDevice #7TitaniumAbutmentBlank NobelBiocare N1TCC (K223677)	Comparison
	InterActive:3.0mm, 3.4mmCylinder: 5.0mm							3.5mm,4.5mm,5.7mm,NobelActive NPand RP,Also, otheridentifiedmanufacturersystemsdiameters andplatforms in the510k
InterfaceConnection	Legacy: Internalhex connectionInterActive:Internal hexconicalconnectionCylinder:External Flatconnection	Internal hexconnection	Internal hexconical connection	N/A	External Flatconnection	External Flatconnection	N/A	Zimmer ScrewVent®/TaperedScrew-Vent® -Internal HexNobelActive -Internal ConicalConnectionwith internalhex	Trioval Conicalconnection	Same
Collar Height	Legacy: 0.25mm- 2.0mmInterActive:1.0mm - 2.0mmCylinder:0.25mm	0.25mm – 2.0mm	1.0mm – 2.0mm	N/A	N/A	N/A	N/A	0.3mm-6mm	0.335 mm -4.6mm	Same
AbutmentMaterial andSurfaceTreatment	Titanium Alloy &Zirconia;abutments aretitaniumanodized goldand pink	Titanium Alloy &Zirconia;abutments aretitanium anodizedgold and pink	Titanium Alloy &Zirconia;abutments aretitanium anodizedgold and pink	N/A	Titanium Alloy	Titanium Alloy	N/A	Titanium Alloy	Titanium Alloy /Anodization	Same
AbutmentDesign	2-pieceAbutment	2-piece Abutment	2-piece Abutment	N/A	2-pieceAbutment	2-piece Abutment	N/A	2-pieceAbutment	2-pieceAbutment	Same

DescriptiveInformation	Subject DeviceSMARTbaseAbutmentSystem(K223535)	PrimaryPredicateLegacy™EngagingSMARTBaseAbutments(K191458)	ReferenceDevice#1InterActive™SMARTBaseAbutment(K181359)	ReferenceDevice#23Shape AbutmentDesigner™Software(K151455)	ReferenceDevice#3SpectrumSystem(K061319)	ReferenceDevice#4Spectrum-SystemAbutments 2008(K081101)	ReferenceDevice #5ExocadAbutmentCAD(K193352)	ReferenceDevice #6DESS DentalSmartSolutions(K222288)	ReferenceDevice #7TitaniumAbutmentBlank NobelBiocare N1TCC (K223677)	Comparison
AbutmentFixation	Abutmentfixation with ascrew	Abutment fixationwith a screw	Abutment fixationwith a screw	N/A	Abutmentfixation with ascrew	Abutment fixationwith a screw	N/A	Abutmentfixation with ascrew	Abutmentfixation with ascrew	Same
Restoration	Zirconia Singleand multi-unit	Zirconia Singleand multi-unit	Zirconia Singleand multi-unit	N/A	Multi-unitdenture	Multi-unit denture	N/A	Single andmulti-unit	Single-unit andmulti-unit (up to3 units)	Same
CementAdhesive	Maxcem Elite(K060469)	EMBRACE(K071278)	EMBRACE(K071278)	N/A	EMBRACE(K071278)	EMBRACE(K071278)	N/A	Multilink HybridAbutmentCement	N/A	Similar
Abutment Angle	≤30 degreesfrom implant axis	≤30 degrees fromimplant axis	≤30 degrees fromimplant axis	N/A	N/A	N/A	N/A	≤30 degreesfrom implantaxis	≤30 degreesfrom implantaxis	Same
Post Height	4.0mm minimum	4.0mm minimum	4.0mm minimum	N/A	4.0mm minimum	4.0mm minimum	N/A	4.0mmminimum	4.0mm minimum	Same
ProsthesisAttachment	Screw- orcement-retained	Screw- orcement-retained	Screw- or cement-retained	N/A	Screw retainedoverdenture	Screw retained	N/A	Screw- orcement-retained typerestoration	Screw orcement-retainedtype restoration	Same
DesignWorkflow	Conventionaland Digital	Conventional andDigital	Conventional andDigital	Digital	Conventional	Conventional	Digital	Digital	Digital	Same
Sterility	Supplied non-sterile; steamsterilized by enduser prior to use	Supplied non-sterile; steamsterilized by enduser prior to use	Supplied non-sterile; steamsterilized by enduser prior to use	N/A	Supplied non-sterile; steamsterilized by enduser prior to use	Supplied non-sterile; steamsterilized by enduser prior to use	N/A	Supplied non-sterile; steamsterilized byend user priorto use	Supplied non-sterile: steamsterilized by enduser prior to use	Same
Use	Single use	Single use	Single use	N/A	Single use	Single use	N/A	Single use	Single use	Same
Performance Testing
Fatigue Testing	Fatigue testingaccording to ISO14801	Fatigue testingaccording to ISO14801	Fatigue testingaccording to ISO14801	N/A	Fatigue testingaccording to ISO14801	Fatigue testingaccording to ISO14801	N/A	Fatigue testingaccording toISO 14801	Fatigue testingaccording to ISO14801	Same
Biocompatibility	Biocompatibleaccording to ISO10993-1:2018	Biocompatibleaccording to ISO10993-1:2018	Biocompatibleaccording to ISO10993-1:2018	N/A	Biocompatibleaccording to ISO10993-1:2018	Biocompatibleaccording to ISO10993-1:2018	N/A	Biocompatibleaccording toISO 10993-1	Biocompatibleaccording to ISO10993-1	Same

Tahle 0-4: SMARThase Abutment System Comnarison Tahle

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x. Performance Testing Data

Non-clinical testing was performed on the Subject device SMARTbase Abutment System:

Fatigue testing in accordance with ISO 14801 and the FDA Guidance Document entitled, "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004).
. Magnetic Resonance compatibility testing according to ASTM F2052, ASTM F2213, ASTM F2119 and ASTM F2182
Verification of biocompatibility of the final device in accordance with ISO 10993-1 ●
Steam sterilization validation in accordance with ISO 17665-1
Shipping validation in accordance with ASTM D4169
. Software verification and validation testing was provided for the subject abutment design library to demonstrate use with both the 3Shape Abutment Designer Software and ExocadAbutmentCAD software. Each 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 and specifications are locked and cannot be modified within the abutment design library.

Clinical Performance Data:

Clinical performance data is not required to establish substantial equivalence for the subject device.

xi. Conclusion

Based on a comparison of intended use, indications, material composition, technological characteristics, principle of operation, features and performance data, the SMARTbase Abutment System is deemed 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.)