Who is the manufacturer of SMARTbase Abutment System?

Implant Direct Sybron Manufacturing, LLC filed the 510(k) submission for SMARTbase Abutment System (K223535).

What is the FDA product code for SMARTbase Abutment System?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for SMARTbase Abutment System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SMARTbase Abutment System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SMARTbase Abutment System

Q: What are the predicate devices for SMARTbase Abutment System?

Legacy™ SMARTBase Abutments (K191458).

K223535 · Implant Direct Sybron Manufacturing, LLC · NHA · Jun 20, 2023 · Dental

Device Facts

Record ID	K223535
Device Name	SMARTbase Abutment System
Applicant	Implant Direct Sybron Manufacturing, LLC
Product Code	NHA · Dental
Decision Date	Jun 20, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2

Intended 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.

Device Story

Two-piece dental abutment system comprising titanium base and zirconia top; used to support prosthetic restorations (crowns/bridges) on endosseous dental implants. Operates via mechanical connection (screw/cement) to implant. Digital workflow utilizes intra-oral scan files, CAD/CAM software (3Shape/Exocad), and milling machines to fabricate patient-specific zirconia tops. Used in dental clinics/laboratories by clinicians/technicians. Output is a custom-designed abutment/restoration. Benefits include patient-specific anatomical fit and restoration of chewing function. System includes fixation screws and accessories (scan adapters, analogs).

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including fatigue testing (ISO 14801), biocompatibility (ISO 10993-1), MRI compatibility (ASTM F2052, F2213, F2119, F2182), steam sterilization validation (ISO 17665-1), and shipping validation (ASTM D4169).

Technological Characteristics

Two-piece abutment system; titanium base (Ti6Al4V ELI, ASTM F136/ISO 5832-3) with gold/pink anodization; zirconia top. Internal hex or conical connections. Dimensions: 3.0-5.7mm platform diameters; 0.25-2.0mm collar heights; 0-30 degree angulation. Supplied non-sterile; steam sterilized by end user. Digital workflow integration via CAD/CAM software libraries. Software is locked to prevent design outside established limitations.

Indications for Use

Indicated for single or multiple unit prosthetic restorations in partially or fully edentulous patients in the mandible or maxilla. Specific indications: SMARTbase for narrow (3.2mmD) Legacy implants: single-tooth replacement of mandibular central/lateral incisors and maxillary lateral incisors. SMARTbase for short (8mm) 3.7mmD Legacy implants: tooth replacement of mandibular and maxillary central and lateral incisors. SMARTbase for narrow diameter (3.2, 3.3mm) InterActive implants: single-tooth replacement of mandibular central/lateral incisors and maxillary lateral incisors, multiple tooth replacements, or denture stabilization.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

Legacy™ SMARTBase Abutments (K191458)

Reference Devices

InterActve™ SMARTBase Abutment (K181359)
3Shape Abutment Designer™ Software (K151455)
Spectrum System (K061319)
Spectrum-System Abutments 2008 (K081101)
ExocadAbutmentCAD (K193352)
DESS Dental Smart Solutions (K222288)
Titanium Abutment Blank Nobel Biocare N1 TCC (K223677)

Related Devices

K251515 — Solidex® Ti-Links and Screws · CreoDent Hudson Valley · Feb 10, 2026
K181359 — InterActive SMARTBase Abutments · Implant Direct Sybron Manufacturing, LLC · Aug 15, 2018
K222913 — s-Clean Link Abutment · Dentis Co., Ltd. · Jan 13, 2023
K251497 — Elos Accurate Hybrid Base · Elos Medtech Pinol A/S · Oct 16, 2025
K220878 — Straumann TLX Variobase C · Institut Straumann AG · Jun 16, 2022

Submission Summary (Full Text)

{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) | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | <div> <svg class="bi bi-check-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> <path d="M10.97 4.97a.75.75 0 0 1 1.071 1.05l-3.992 4.99a.75.75 0 0 1-1.08.02L4.324 8.384a.75.75 0 1 1 1.06-1.06l2.094 2.093 3.473-4.425a.235.235 0 0 1 .02-.022z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </div> | | | <div> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | #### 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 | Product Code | 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 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)…