Predicate Devices

Reference Devices

K181359, K151455, K061319, K081101, K193352, K222288, K223677

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental abutment system and its integration with standard CAD/CAM workflows and software, but there is no mention of AI or ML being used in the design, manufacturing, or function of the device itself or the associated software.

Therapeutic

No
A therapeutic device is used to treat or cure a disease or condition. This device is an abutment system for dental implants, designed to provide support for prosthetic restorations in partially or fully edentulous patients. It does not actively treat or cure any disease or condition; rather, it is a restorative component for dental prosthetics.

Diagnostic

No

Explanation: The SMARTbase Abutment System is designed to support prosthetic restorations for dental implants. Its function is to provide structural support for prosthetics, not to diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

No

The device is a physical dental implant abutment system comprised of titanium and zirconia components. While it integrates with software for design and fabrication, the core device itself is hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, the SMARTbase Abutment System is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the device is designed to provide support for prosthetic restorations in a patient's mouth. This is a direct clinical application within the body, not a test performed on samples outside the body to diagnose a condition.
Device Description: The description details a physical implant abutment system used for dental restoration. It involves components like titanium bases, zirconia tops, and fixation screws, all designed for surgical implantation and prosthetic support.
Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's health status. The workflow described is focused on designing and fabricating a dental prosthesis.
Performance Studies: The performance studies listed are related to the mechanical properties, biocompatibility, and software compatibility of the device for its intended use in dental restoration, not for diagnostic accuracy.

In summary, the SMARTbase Abutment System is a medical device used for dental restoration, not an IVD device used for diagnosis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes

NHA, PNP

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

scan files from Intra-oral Scanners and lab scanners

Anatomical Site

mandible or maxilla

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K191458

Reference Device(s)

K181359, K151455, K061319, K081101, K193352, K222288, K223677

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.)

Summary

0

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.

1

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

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

For comprehensive regulatory information about 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

2

Indications for Use

510(k) Number (if known) K223535

Device Name

SMARTbase Abutment System

Indications for Use (Describe)

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.

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

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 Sybron
Manufacturing LLC
3050 E. Hillcrest Drive
Thousand Oaks, CA
91362, 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

4

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

5

Reference Device #5
Proprietary Name:	ExocadAbutmentCAD (K193352)
Manufacturer:	Exocad GmbH
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 #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

6

iv. 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.

| | LegacyTM
SMARTbase
Abutment | InterActiveTM
SMARTbase
Abutment | SMARTbase
Cylinders |
|----------------------------|--------------------------------------|-----------------------------------------------|--------------------------------|
| Platform Diameter | 3.0mm, 3.5mm,
4.5mm, and
5.7mm | 3.0mm and 3.4mm | 5.0mm |
| Titanium Base
Height | 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 Collar
Height* | 0.25, 1, 2mm | 1 and 2mm | 0.25mm |
| Abutment
Angulation | 0 to 30 degrees | 0 to 30 degrees | 0 to 30 degrees |
| Abutment Post
Height | 4mm minimum | 4mm minimum | 4mm minimum |
| Zirconia Wall
Thickness | Single Unit:
Wall thickness | Single Unit:
Wall thickness | Single Unit:
Wall thickness |

Table 0-1 Design Specifications for SMARTbase Abutment System

7

| circular: 0.9mm
minimum | circular: 0.9mm
minimum | circular: 0.9mm
minimum |
|----------------------------|----------------------------|----------------------------|
| 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.

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):

8

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.

9

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

| Product Name Code | Regulation # | Device Class Clearance |
|--------------------------------| | InterActive™, SwishActive™ and | DZE | simply InterActive™ Implants | | Simply Iconic™ Implants | InterActive™ Abutments | ScrewIndirect™ Implants | Legacy™ Implants | | | Legacy™ MUA | | | | | InterActive™ MUA | | | Fixation Screw | NHA | | | Scan Adapter | NDP | Castable Coping | NDP | Implant Analog | NDP | Off-axis Tools | NDP | Product
| 510(k)
-----------------|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| 872.3640 | | K130572 |
| | | K143011 |
| DZE | 872.3640 | ============================================================================================================================================================================== | K210553 |
| NHA | 872.3630 | ============================================================================================================================================================================== | K130572 |
| DZE | 873.3640 | ============================================================================================================================================================================== | K080633 |
| DZE | 873.3640 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | K192221 |
| | | K073033 |
| NHA | 872.3630 | | K090234 |
| | | K060063 |
| | | K061319 |
| INHA | 872.3630 | | K153509 |
| | | |
| 873.3630 | | K181359 |
| | | K192458 |
| 872.3980 | | EXEMPT |
| 872.3980 | | EXEMPT |
| 872.3980 | | EXEMPT |
| 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 Abutment
System	Titanium 6AL4V ELI (ASTM F136 / ISO 5832-3) and
Zirconia	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

10

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.

11

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.

12

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.

13

Table 0-4: SMARTbase Abutment System Comparison Table
Descriptive
Information	Subject Device
SMARTbase
Abutment
System
(K223535)	Primary
Predicate
Legacy™
Engaging
SMARTBase
Abutments
(K191458)	Reference
Device#1
InterActive™
SMARTBase
Abutment
(K181359)	Reference
Device#2
3Shape Abutment
Designer™
Software
(K151455)	Reference
Device#3
Spectrum
System
(K061319)	Reference
Device#4
Spectrum-
System
Abutments 2008
(K081101)	Reference
Device #5
Exocad
AbutmentCAD
(K193352)	Reference
Device #6
DESS Dental
Smart
Solutions
(K222288)	Reference
Device #7
Titanium
Abutment
Blank Nobel
Biocare N1
TCC (K223677)	Comparison
Manufacturer	Implant Direct	Implant Direct	Implant Direct	3Shape A/S	Implant Direct	Implant Direct	Exocad GmbH	Terrats Medical
SL	Nobel Biocare	Same
Pictorial
Representation	Image: [abutments]	Image: [abutment]	Image: [abutment]	N/A	Image: [abutments]	Image: [abutments]	N/A	Image: [abutment]	Image: [abutment]	N/A
Regulatory Classification
Regulation #	21 CFR
872.3630	21 CFR 872.3630	21 CFR 872.3630	21 CFR 872.3630	21 CFR
872.3630	21 CFR 872.3630	21 CFR
872.3630	21 CFR
872.3630	21 CFR
872.3630	Same
Regulation Title	Endosseous
dental implant
abutment	Endosseous
dental implant
abutment	Endosseous
dental implant
abutment	Endosseous dental
implant abutment	Endosseous
dental implant
abutment	Endosseous
dental implant
abutment	Endosseous
dental implant
abutment	Endosseous
dental implant
abutment	Endosseous
Dental Implant
Abutment	Same
Regulation
Class	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 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 or fully
edentulous
patient.	The Legacy™
SMARTbase
Abutment system
is designed to be
used in support
of a dental
implant(s) to
provide support
for prosthetic
restorations in a
partially
edentulous
patient.	InterActive/SwishA
ctive 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	The 3Shape
Abutment Designer
Software is
intended as an aid
to the restoration of
chewing function in
partially or fully
edentulous
mandibles and
maxillae. The
3Shape Abutment
Designer Software
is intended for use
by a dental	The Spectra
Dental Implant
System consists
of one-piece or
two-piece
implants for
single-stage or
two- stage
surgical
procedures that
are intended for
use in partially
or fully
edentulous	Spectra-System
Abutments are
designed to be
used in support of
a dental implant(s)
to provide support
for prosthetic
restorations such
as crowns,
bridges,
overdentures or
custom prosthetic
fabrications in a
partially or	The
AbutmentCAD
module is
intended as an
aid to the
restoration of
chewing function
in partially or
fully edentulous
mandibles and
maxillae.
AbutmentCAD is
a software
device intended	DESS Dental
Smart
Solutions
abutments are
intended to be
used in
conjunction
with
endosseous
dental implants
in the maxillary
or mandibular
arch to provide
support for	Titanium
Abutment Blank
Nobel Biocare
N1 ™ TCC is a
premanufactured
prosthetic
component
directly
connected to an
endosseous
dental implant
and is indicated
for use as an aid
in prosthetic	Same - Proposed,
predicate, and
reference devices
are indicated for
use with dental
implants to provide
support for single
unit or multiple unit
prosthetic
restorations for
partially or fully
edentulous patients
in the mandible or
maxilla.
Descriptive
Information	Subject Device
SMARTbase
Abutment
System
(K223535)	Primary
Predicate
Legacy™
Engaging
SMARTBase
Abutments
(K191458)	Reference
Device#1
InterActive™
SMARTBase
Abutment
(K181359)	Reference
Device#2
3Shape Abutment
Designer™
Software
(K151455)	Reference
Device#3
Spectrum
System
(K061319)	Reference
Device#4
Spectrum-
System
Abutments 2008
(K081101)	Reference
Device #5
Exocad
AbutmentCAD
(K193352)	Reference
Device #6
DESS Dental
Smart
Solutions
(K222288)	Reference
Device #7
Titanium
Abutment
Blank Nobel
Biocare N1
TCC (K223677)	Comparison
	SMARTbase
Abutment
System is
intended for use
in the mandible
or maxilla in
support of single
or multiple unit
restorations.
The
SMARTbase
Abutment
System	Legacy
SMARTBase
engaging
abutments are
intended for use
in the mandible
or maxilla in
support of single
unit restorations.
The Legacy
SMARTBase
Abutment system
integrates
multiple	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,	practitioner or
dental laboratory
staff for designing
the patient specific
component of a
two-piece, one-
piece, or hybrid
dental implant
abutment. The
single or multi-unit
abutment design is
intended to be used
by the
manufacturer of an	mandibles and
maxillae, in
support of single
or multiple-unit
restorations and
terminal or
intermediate
abutment
support for fixed
bridgework.
They may be
placed in
immediate
function if initial	completely
edentulous
patient. Spectra-
System
Abutments are
intended for use in
the mandible or
maxilla.
Prostheses can be
screw or cement
retained to the
abutment	to be used by
trained
professionals in
dental practices
or dental
laboratories for
the design of
patient specific
implant borne
prosthetics such
as one-piece
abutments, two-
piece/hybrid
abutments,	prosthetic
restorations.
All digitally
designed
custom
abutments for
use with Ti
Base
abutments or
Pre-milled
Blank
abutments are
to be sent to a
Terrats Medical	rehabilitation for
single units and
multiple units of
up to three units
The system
integrates
multiple
components of
the digital
dentistry
workflow scan
files from Intra-
Oral Scanners,
CAD software,	Abutments are
compatible with the
same implants
having the same
platform sizes and
thread sizes.
The restorations
are made using
either a
conventional or
digital workflow.
	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	components for
use in both a
traditional &
digital dentistry
workflow: scan
files from Intra-
oral Scanners &
lab scanners,
CAD software,
CAM software,
ceramic material,
milling machine
and associated
tooling and
accessories. The
Legacy
SMARTbase
system consist of
two major parts:
the titanium base
and zirconia top
components
make up a two-
piece abutment.	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.	endosseous dental
implant abutment to
create the final
device.	implant stability
can be
established. The
Screw Indirect
implant is
indicated for the
support and
retention of bar
overdentures or
as a terminal or
intermediary
attachment for
screw-retained
fixed
bridgework. It is
indicated for
immediate
functional
loading when
four or more
implants are
splinted together
in the
edentulous		single or multi-
unit screw-
retained
restorations.
The design
result is
intended to be
used by the
manufacturer of
an endosseous
dental implant
abutment to
create the final
device.	validated
milling center
for
manufacture.	CAM software,
restoration
material blanks,
milling machine
and associated
tooling and
accessories
Descriptive
Information	Subject Device
SMARTbase
Abutment
System
(K223535)	Primary
Predicate
Legacy™
Engaging
SMARTBase
Abutments
(K191458)	Reference
Device#1
InterActive™
SMARTBase
Abutment
(K181359)	Reference
Device#2
3Shape Abutment
Designer™
Software
(K151455)	Reference
Device#3
Spectrum
System
(K061319)	Reference
Device#4
Spectrum-
System
Abutments 2008
(K081101)	Reference
Device #5
Exocad
AbutmentCAD
(K193352)	Reference
Device #6
DESS Dental
Smart
Solutions
(K222288)	Reference
Device #7
Titanium
Abutment
Blank Nobel
Biocare N1
TCC (K223677)	Comparison
	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	•Legacy
SMARTbase
abutment for
narrow dimeter
(3.2mmD)
implants:
Indicated for
single- tooth
replacement of
mandibular
central and
lateral incisors
and maxillary
lateral incisors.
•Legacy
SMARTbase
abutment for
short (8mm)
3.7mmD
implants: Not
intended for tooth
replacement of
canines, pre-
molars or molars.	•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.		upper or lower
jaw. This implant
model is not
indicated for use
with abutments,
only with a 2mm
extender.
Descriptive
Information	Subject Device
SMARTbase
Abutment
System
(K223535)	Primary
Predicate
Legacy™
Engaging
SMARTBase
Abutments
(K191458)	Reference
Device#1
InterActive™
SMARTBase
Abutment
(K181359)	Reference
Device#2
3Shape Abutment
Designer™
Software
(K151455)	Reference
Device#3
Spectrum
System
(K061319)	Reference
Device#4
Spectrum-
System
Abutments 2008
(K081101)	Reference
Device #5
Exocad
AbutmentCAD
(K193352)	Reference
Device #6
DESS Dental
Smart
Solutions
(K222288)	Reference
Device #7
Titanium
Abutment
Blank Nobel
Biocare N1
TCC (K223677)	Comparison
	single-tooth
replacement of
mandibular
central and
lateral incisors
and maxillary
lateral incisors.
Also indicated
for multiple tooth
replacements or
denture
stabilization.
Compatibility	• LegacyTM1:
body diameter
3.7 – 5.7mm;
platform
diameter 3.5,
4.5, 5.7mm;
implant length
8- 16mm,
excluding 6mm
length
• LegacyTM2, 3,
4,
simplyLegacy2
& 3: body
diameter
3.2 - 7.0mm;
platform
diameter 3.0,
3.5, 4.5, 5.7mm;
implant length 8-
16mm, excluding
6mm length
• InterActive™:
body diameter
3.2-5.0mm;
platform	Legacy
SMARTBase
engaging
abutments are
compatible at the
implant level with
Legacy (3.0mm,
3.5mm, 4.5mm
and 5.7mm
platform
diameter)
implants,
excluding 6mm
length implants.
*Legacy1: body
diameter 3.7 -
5.7mm; platform
diameter 3.5, 4.5,
5.7mm; implant
length 8- 16mm,
excluding 6mm
length
•Legacy2, 3, 4,
simplyLegacy2 &
3: body diameter	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.
*InterActive: body
diameter 3.2-
5.0mm;
platform diameter
3.0,
3.4mm; implant
length 8- 16mm,
excluding 6mm
length
*SwishActive:
body diameter 3.3-
4.8mm; platform
diameter 3.0,	N/A	Screw Indirect
Implants (5.0mm
Platform),
Legacy and
InterActive
MUAs (5.0mm
Platform)	Screw Indirect
Implant (5.0mm
Platform), Legacy
and InterActive
MUAs (5.0mm
Platform)	N/A	Ankylos C/X,
Astra Tech EV,
Astra Tech
OsseoSpeed™
3.0,
BioHorizons,
Biomet 3i
Certain®,
Biomet 3i
OSSEOTITE®,
Camlog,
Dentium
SuperLine,
FRIADENT
XiVE®,
MegaGen
AnyRidge,
Neodent Grand
Morse,
NobelActive®,
NobelParallel
Conical,
NobelReplace®
Trilobe, Nobel
Brånemark
System®,	Narrow Platform
(NP)
Regular
Platform (RP)
N1 TiUltra TCC
implants	Similar; the added
compatibility
information for
device does not
raise any safety
and efficacy
question as it is
supported by
fatigue test data.
Descriptive
Information	Subject Device
SMARTbase
Abutment
System
(K223535)	Primary
Predicate
Legacy™
Engaging
SMARTBase
Abutments
(K191458)	Reference
Device#1
InterActive™
SMARTBase
Abutment
(K181359)	Reference
Device#2
3Shape Abutment
Designer™
Software
(K151455)	Reference
Device#3
Spectrum
System
(K061319)	Reference
Device#4
Spectrum-
System
Abutments 2008
(K081101)	Reference
Device #5
Exocad
AbutmentCAD
(K193352)	Reference
Device #6
DESS Dental
Smart
Solutions
(K222288)	Reference
Device #7
Titanium
Abutment
Blank Nobel
Biocare N1
TCC (K223677)	Comparison
	diameter 3.0,
3.4mm; implant
length 8- 16mm,
excluding 6mm
length
•SwishActive™:
body diameter
3.3-4.8mm;
platform
diameter 3.0,
3.4mm; implant
length 8- 16mm,
excluding 6mm
length
ScrewIndirect™:
body diameter
3.0-5.7mm;
platform
diameter 5.0mm;
implant length 8-
16mm Legacy™
Multi-unit
Abutment:
Abutment
platform
diameter 5.0mm;
InterActive™
Multi-unit
Abutment:
Abutment
platform
diameter 5.0mm	3.2 - 7.0mm;
platform diameter
3.0, 3.5, 4.5,
5.7mm; implant
length 8- 16mm,
excluding 6mm
length	3.4mm; implant
length 8- 16mm,
excluding 6mm
length					Osstem TS,
Straumann
BLX,
Straumann®
Bone Level,
Straumann®
Tissue Level,
Zimmer Eztetic,
Zimmer Screw
Vent®/
Tapered
Screw-
Vent®, Zimmer
Spline, Zimmer
SwissPlus
					Technological Characteristics
Interface
Platform
Diameter	Legacy: 3.0mm,
3.5mm, 4.5mm,
and 5.7mm	3.0mm, 3.5mm,
4.5mm, and
5.7mm	3.0mm and 3.4mm	N/A	5.0mm	5.0mm	N/A	Zimmer Screw
Vent®/
Tapered
Screw-Vent® -	NP, RP	Same
Descriptive
Information	Subject Device
SMARTbase
Abutment
System
(K223535)	Primary
Predicate
LegacyTM
Engaging
SMARTBase
Abutments
(K191458)	Reference
Device#1
InterActive™
SMARTBase
Abutment
(K181359)	Reference
Device#2
3Shape Abutment
Designer™
Software
(K151455)	Reference
Device#3
Spectrum
System
(K061319)	Reference
Device#4
Spectrum-
System
Abutments 2008
(K081101)	Reference
Device #5
Exocad
AbutmentCAD
(K193352)	Reference
Device #6
DESS Dental
Smart
Solutions
(K22288)	Reference
Device #7
Titanium
Abutment
Blank Nobel
Biocare N1
TCC (K223677)	Comparison
	InterActive:
3.0mm, 3.4mm
Cylinder: 5.0mm							3.5mm,4.5mm,
5.7mm,
NobelActive NP
and RP,
Also, other
identified
manufacturer
systems
diameters and
platforms in the
510k
Interface
Connection	Legacy: Internal
hex connection
InterActive:
Internal hex
conical
connection
Cylinder:
External Flat
connection	Internal hex
connection	Internal hex
conical connection	N/A	External Flat
connection	External Flat
connection	N/A	Zimmer Screw
Vent®/
Tapered
Screw-Vent® -
Internal Hex
NobelActive -
Internal Conical
Connection
with internal
hex	Trioval Conical
connection	Same
Collar Height	Legacy: 0.25mm

2.0mm
InterActive:
1.0mm - 2.0mm
Cylinder:
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 | |
| Abutment
Material and
Surface
Treatment | Titanium Alloy &
Zirconia;
abutments are
titanium
anodized gold
and pink | Titanium Alloy &
Zirconia;
abutments are
titanium anodized
gold and pink | Titanium Alloy &
Zirconia;
abutments are
titanium anodized
gold and pink | N/A | Titanium Alloy | Titanium Alloy | N/A | Titanium Alloy | Titanium Alloy /
Anodization | Same | |
| Abutment
Design | 2-piece
Abutment | 2-piece Abutment | 2-piece Abutment | N/A | 2-piece
Abutment | 2-piece Abutment | N/A | 2-piece
Abutment | 2-piece
Abutment | Same | |
| | | | | | | | | | | | |
| Descriptive
Information | Subject Device
SMARTbase
Abutment
System
(K223535) | Primary
Predicate
Legacy™
Engaging
SMARTBase
Abutments
(K191458) | Reference
Device#1
InterActive™
SMARTBase
Abutment
(K181359) | Reference
Device#2
3Shape Abutment
Designer™
Software
(K151455) | Reference
Device#3
Spectrum
System
(K061319) | Reference
Device#4
Spectrum-
System
Abutments 2008
(K081101) | Reference
Device #5
Exocad
AbutmentCAD
(K193352) | Reference
Device #6
DESS Dental
Smart
Solutions
(K222288) | Reference
Device #7
Titanium
Abutment
Blank Nobel
Biocare N1
TCC (K223677) | Comparison | |
| Abutment
Fixation | Abutment
fixation with a
screw | Abutment fixation
with a screw | Abutment fixation
with a screw | N/A | Abutment
fixation with a
screw | Abutment fixation
with a screw | N/A | Abutment
fixation with a
screw | Abutment
fixation with a
screw | Same | |
| Restoration | Zirconia Single
and multi-unit | Zirconia Single
and multi-unit | Zirconia Single
and multi-unit | N/A | Multi-unit
denture | Multi-unit denture | N/A | Single and
multi-unit | Single-unit and
multi-unit (up to
3 units) | Same | |
| Cement
Adhesive | Maxcem Elite
(K060469) | EMBRACE
(K071278) | EMBRACE
(K071278) | N/A | EMBRACE
(K071278) | EMBRACE
(K071278) | N/A | Multilink Hybrid
Abutment
Cement | N/A | Similar | |
| Abutment Angle | ≤30 degrees
from implant axis | ≤30 degrees from
implant axis | ≤30 degrees from
implant axis | N/A | N/A | N/A | N/A | ≤30 degrees
from implant
axis | ≤30 degrees
from implant
axis | Same | |
| Post Height | 4.0mm minimum | 4.0mm minimum | 4.0mm minimum | N/A | 4.0mm minimum | 4.0mm minimum | N/A | 4.0mm
minimum | 4.0mm minimum | Same | |
| Prosthesis
Attachment | Screw- or
cement-retained | Screw- or
cement-retained | Screw- or cement-
retained | N/A | Screw retained
overdenture | Screw retained | N/A | Screw- or
cement-
retained type
restoration | Screw or
cement-retained
type restoration | Same | |
| Design
Workflow | Conventional
and Digital | Conventional and
Digital | Conventional and
Digital | Digital | Conventional | Conventional | Digital | Digital | Digital | Same | |
| Sterility | Supplied non-
sterile; steam
sterilized by end
user prior to use | Supplied non-
sterile; steam
sterilized by end
user prior to use | Supplied non-
sterile; steam
sterilized by end
user prior to use | N/A | Supplied non-
sterile; steam
sterilized by end
user prior to use | Supplied non-
sterile; steam
sterilized by end
user prior to use | N/A | Supplied non-
sterile; steam
sterilized by
end user prior
to use | Supplied non-
sterile: steam
sterilized by end
user 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 testing
according to ISO
14801 | Fatigue testing
according to ISO
14801 | Fatigue testing
according to ISO
14801 | N/A | Fatigue testing
according to ISO
14801 | Fatigue testing
according to ISO
14801 | N/A | Fatigue testing
according to
ISO 14801 | Fatigue testing
according to ISO
14801 | Same | |
| Biocompatibility | Biocompatible
according to ISO
10993-1:2018 | Biocompatible
according to ISO
10993-1:2018 | Biocompatible
according to ISO
10993-1:2018 | N/A | Biocompatible
according to ISO
10993-1:2018 | Biocompatible
according to ISO
10993-1:2018 | N/A | Biocompatible
according to
ISO 10993-1 | Biocompatible
according to ISO
10993-1 | Same | |

Tahle 0-4: SMARThase Abutment System Comnarison Tahle

14

15

16

17

18

19

20

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.