Who is the manufacturer of InterActive SMARTBase Abutments?

Implant Direct Sybron Manufacturing, LLC filed the 510(k) submission for InterActive SMARTBase Abutments (K181359).

What is the FDA product code for InterActive SMARTBase Abutments?

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

What is the regulatory pathway for InterActive SMARTBase Abutments?

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

Who can help prepare an FDA 510(k) submission like InterActive SMARTBase Abutments?

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.

InterActive SMARTBase Abutments

Q: What are the predicate devices for InterActive SMARTBase Abutments?

InterActive/SwishActive Implant System (K143011).

K181359 · Implant Direct Sybron Manufacturing, LLC · NHA · Aug 15, 2018 · Dental

Device Facts

Record ID	K181359
Device Name	InterActive SMARTBase Abutments
Applicant	Implant Direct Sybron Manufacturing, LLC
Product Code	NHA · Dental
Decision Date	Aug 15, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended Use

InterActive/SwishActive Implant System consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate SMARTBase support for fixed bridgework. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTBase Abutments consist of two major parts. Specifically, the titanium base and zirconia top components make up a two-piece abutment. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. Narrow Diameter (3.2, 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.

Device Story

Two-piece dental abutment system comprising titanium base and zirconia top; functions as extension of endosseous dental implant. Used in partially/fully edentulous patients for single/multiple-unit restorations or fixed bridgework. Workflow options: conventional wax-up/press-ceramic; stock zirconia components; or digital workflow using 3Shape CAD software and milling machines. Digital workflow requires loading proprietary design library to 3Shape software to ensure design within established limitations. Clinician/dental lab staff design zirconia top; milled component placed on titanium base. Output is physical abutment assembly. Device provides prosthetic support for dental restorations; benefits patient by restoring chewing function and aesthetics. Used in dental office/laboratory settings.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing: mechanical fatigue testing (ISO 14801), screw torque testing, biocompatibility (ISO 10993-5), and software verification/validation of the design library.

Technological Characteristics

Materials: Titanium alloy and zirconia. Connection: Internal hex conical. Dimensions: 3.0mm/3.4mm platform; 4.9mm-5.7mm diameter; 4mm+ post height. Angulation: 0°-30°. Connectivity: Digital design library for 3Shape CAD software. Sterilization: Non-sterile, steam sterilization by end-user (ISO 17665-1/2). Surface: Anodized titanium.

Indications for Use

Indicated for partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and fixed bridgework. Narrow diameter implants (3.2, 3.3mm) indicated for single-tooth replacement of mandibular central/lateral incisors and maxillary lateral incisors, or multiple tooth replacements/denture stabilization. Suitable for immediate loading given primary stability.

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

InterActive/SwishActive Implant System (K143011)

Reference Devices

InterActive/SwishPlus2 Implant System (K130572)
Sirona Dental CAD/CAM System (K111421)
3Shape Abutment Designer™ Software (K151455)

Related Devices

K223535 — SMARTbase Abutment System · Implant Direct Sybron Manufacturing, LLC · Jun 20, 2023
K251515 — Solidex® Ti-Links and Screws · CreoDent Hudson Valley · Feb 10, 2026
K231411 — INNO SLA Submerged Hybrid Ti-Base System · Cowellmedi Co., Ltd. · Dec 20, 2023
K251497 — Elos Accurate Hybrid Base · Elos Medtech Pinol A/S · Oct 16, 2025
K242025 — Elos Accurate® Hybrid Base · Elos Medtech Pinol A/S · Dec 10, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and abbreviation on the right. The symbol on the left is a stylized representation of human services. To the right of the symbol is the FDA abbreviation in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. August 15, 2018 Implant Direct Sybron Manufacturing LLC Reina Choi Senior Regulatory Affairs Specialist 3050 East Hillcrest Drive Thousand Oaks, California 91362 Re: K181359 Trade/Device Name: InterActive SMARTBase Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: May 18, 2018 Received: May 22, 2018 ## Dear Reina Choi: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Andrew I. Steen -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Food and Drug Administration # Indications for Use Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) #### K181359 Device Name #### InterActive SMARTBase Abutments Indications for Use (Describe) InterActive/SwishActive Implant System consists of two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or internediate SMARTBase support for fixed bridgework. The system integrates of the digital dentistry workflow scan files from Intra-Oral Scanners, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTBase Abutments consist of two major parts. Specifically, the titanium base and zirconia top components make up a two-piece abutment. lmplants can be indicated for immediate loading when stability has been achieved and with appropriate occlusal loading. - Narrow Diameter (3.2, 3.3mm) Implants: Indicated for single-tooth replacement of mandbular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization. Compatibility: InterActive SMARTBase abutments are compatible at the implant level with InterActive (3.0mm and 3.4mm Platform) and SwishActive (3.0mm and 3.4mm Platform) system implants. | Manufacturer | Implant Line | Body Diameter | Implant Platform | |----------------|--------------|----------------------------|------------------| | Implant Direct | InterActive | 3.2mm, 3.7mm, 4.3mm, 5.0mm | 3.0mm, 3.4mm | | Implant Direct | SwishActive | 3.3mm, 4.1mm, 4.8mm | 3.0mm, 3.4mm | | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | ☑ Prescription Use (Part 21 CER 801 Subpart D) | ☐ Over-The-Counter Use (21 CER 801 Subpart C) | #### 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. The logo consists of an orange and gray graphic on the left, followed by the text "IMPLANT DIRECT" in gray. The "TM" symbol is located to the right of the word "DIRECT". 3050 E. Hillcrest Drive Thousand Oaks, CA 91362 USA K181359 #### 510(k) SUMMARY #### 1. SUBMITTER Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362 Date Prepared: August 3, 2018 Contact Person: Reina Choi Senior Regulatory Affairs Specialist 818-444-3306 reina.choi@implantdirect.com #### 2. DEVICE NAME | Proprietary Name: | InterActive SMARTBase Abutments | |-------------------------|---------------------------------------------------------| | Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) | | Primary Product Code: | NHA | | Secondary Product Code: | PNP | #### 3. PREDICATE DEVICE(S) - InterActive/SwishActive Implant System (K143011) Primary Predicate ● - . InterActive/SwishPlus2 Implant System (K130572) - Reference Device - Sirona Dental CAD/CAM System (K111421) Reference Device . - 3Shape Abutment Designer™ Software (K151455) Reference Device . ## 4. DEVICE DESCRIPTION {4}------------------------------------------------ The InterActive SMARTBase abutments system is a line extension of the previously cleared Implant Direct device, 2014 InterActive/SwishActive Implant System. The InterActive SMARTBase abutments are comprised of engaging abutments, non-engaging abutments, modified zirconia engaging abutments, modified zirconia non-engaging multiunit bridges, and fixation screws that are intended to function as an extension of the implant. The proposed SMARTBase Abutment is a two-piece abutment consisting of titanium base and zirconia top components. To fabricate the zirconia top component that fits the titanium base, there are three workflow options: (1) using a press-ceramic material that is formed by conventional wax-up technique by the end user, (2) the zirconia top component is designed and milled by Implant Direct in stock sizes and provided to the end user to be placed on the titanium base for forming two-piece abutment, and (3) digital workflow using 3Shape where CAD design and milling of the zirconia top component is done at the end user's dental laboratory/office to be placed on the titanium base. The CAD design requires loading of Implant Direct abutment design library to the 3Shape Software to design the zirconia top component within the established design limitations and specifications. The digital workflow includes the use of the following products (note that these are not subject devices to this submission): - . Ceramic material: Zenostar MT - Cement: EMBRACE Wetbond Resin Cement . - Intra oral scanners: 3M Tru-Definition, ITero Scanner - Abutment design software: 3Shape Abutment Designer™ Software (K151455) ● - Milling machine: Wieland-Zenotec Select & Zenotec CAM . | Type | Material | Implant Platform/ Connection Hex | Abutment Diameter/ Cuff Heights | Post Heights | Angulation | |-------------------------------------------------------------------------|--------------------------------|-------------------------------------|------------------------------------|-----------------|-------------| | Engaging Abutments | Titanium Alloy/ Zirconia | 3.0mmD/2.2mm 3.4mmD/2.6mm | 4.9mm Minimum/ 1mm & 2mm | 4mm Minimum | 0° to 30° | | Non-engaging Abutments | Titanium Alloy/ Zirconia | 3.0mmD 3.4mmD | 5.7mm Minimum/ 1mm & 2mm | 4mm Minimum | 0° to 30° | | Standard Straight and Angled Zirconia engaging Abutments | Titanium Alloy/ Zirconia | 3.0mmD/2.2mm 3.4mmD/2.6mm | 4.9 mm Minimum/ 1mm & 2mm | 4mm Minimum | 0°, 8°, 15° | | Modified Zirconia engaging | Titanium Alloy/ Zirconia | 3.0mmD/2.2mm 3.4mmD/2.6mm | 4.9mm Minimum/ 1mm & 2mm | 4mm Minimum | 0° to 30° | TABLE 1. Product Specifications {5}------------------------------------------------ | Abutments | | | | | | |----------------------------------------------------------------|--------------------------------|------------------|-----------------------------|-----|----------| | Modified zirconia non- engaging multi-unit bridges | Titanium Alloy/ Zirconia | 3.0mmD 3.4mmD | 5.7mm Minimum/ 1mm & 2mm | N/A | 0 to 30° | | Fixation Screws | Titanium Alloy | 3.0mmD 3.4mmD | N/A | N/A | N/A | ## TABLE 2. Compatible Implants with Proposed InterActive SMARTBase Abutments | Implant Brand (Manufacturer) | 510(k) # | Model | |---------------------------------------------|--------------------|--------------------------------------------------------------------------------------| | Implant Direct Sybron Manufacturing, LLC | K143011 K130572 | InterActive Implant System and SwishActive Implant System (Conical connection) | # 5. INDICATIONS FOR USE InterActive/SwishActive Implant System consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate SMARTBase support for fixed bridgework. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTBase Abutments consist of two major parts. Specifically, the titanium base and zirconia top components make up a two-piece abutment. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. - Narrow Diameter (3.2. 3.3mm) Implants: Indicated for single-tooth replacement of ● mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization. #### Compatibility: InterActive SMARTBase abutments are compatible at the implant level with InterActive (3.0mm and 3.4mm Platform) and SwishActive (3.0mm and 3.4mm Platform) system implants. | Manufacturer | Implant Line | Body Diameter | Implant Platform | |--------------|--------------|---------------|------------------| |--------------|--------------|---------------|------------------| {6}------------------------------------------------ | Implant Direct | InterActive | 3.2mm, 3.7mm, 4.3mm, 5.0mm | 3.0mm, 3.4mm | |----------------|-------------|----------------------------|--------------| | Implant Direct | SwishActive | 3.3mm, 4.1mm, 4.8mm | 3.0mm, 3.4mm | {7}------------------------------------------------ | Technological Characteristics | Proposed Device: InterActive SMARTBase Abutments (K181359) | Primary Predicate: InterActive Engaging Abutments(K143011) | Reference Device: InterActive Non-Engaging Abutments (K130572) | Reference Device: Sirona Dental CAD/CAM-System (K111421) | Reference Device: 3Shape Abutment Designer™ Software (K151455) | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Implant Direct Sybron Manufacturing, LLC | Implant Direct Sybron Manufacturing, LLC | Implant Direct Sybron Manufacturing, LLC | Dentsply - Sirona | 3Shape | | Indications for Use | InterActive/SwishActive Implant System consists of two-piece implants for one-stage or two- stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate SMARTBase abutment support for fixed bridgework. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTBase Abutments consist of two major parts. Specifically, the titanium base and zirconia top components make up a two- piece abutment. Implants can be indicated for immediate loading when good primary stability has been | InterActive/SwishActive Implant System consists of two-piece implants for one- stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. Narrow Diameter (3.2, 3.3mm) Implants: Indicated for single- tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. These implants are also indicated for multiple tooth replacements or denture stabilization. | InterActive/SwishPlus2 Implant System consists of two-piece implants for one- stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple- unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. Narrow Diameter (3.2. 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization. | The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple- unit cement retained restorations. The system consists of three major parts: TiBase, InCoris mesostructure, and CAD/CAM software. Specifically, the InCoris mesostructure and TiBase components make up a two- piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The InCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.xxxx) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the InCoris mesostructure. | 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 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 endosseous dental implant abutment to create the final device. | | Technological Characteristics | Proposed Device: InterActive SMARTBase Abutments (K181359) | Primary Predicate: InterActive Engaging Abutments(K143011) | Reference Device: InterActive Non-Engaging Abutments (K130572) | Reference Device: Sirona Dental CAD/CAM-System (K111421) | Reference Device: 3Shape Abutment Designer™ Software (K151455) | | | achieved and with appropriate occlusal loading. Narrow Diameter (3.2, 3.3mm) Implants: Indicated for single- tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization. | | | | | | Compatibility | InterActive SMARTBase abutments are compatible at the implant level with InterActive (3.0mm and 3.4mm Platform) and SwishActive (3.0mm and 3.4mm Platform) system implants. | InterActive and SwishActive implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActive™ NP (Narrow Platform – 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection NobelActive™ NP (Narrow Platform- 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) (3.5-5.0mmD, 8.5- 18mmLength) implants. | InterActive and SwishPlus2 implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActive™ NP (Narrow Platform - 3.0mm diameter) and NobelActive™ RP (Regular Platform – 3.4mm diameter) abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection NobelActive™ NP (Narrow Platform- 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) (3.5- 5.0mmD, 8.5-18mmLength) implants. | The InCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems: Nobel Biocare Replace (K020646), Nobel Biocare Branemark (K022562), Friadent Xive (K013867), Biomet 3i Osseotite (K980549), Astra Tech Osseospeed (K091239), Zimmer Tapered Screw-Vent (K061410), Straumann Synocta (K061176), Straumann Bone Level (K053088), Biomet 3i Certain (K014235), Nobel Biocare Active (K071370). | N/A | | Technological Characteristics | Proposed Device: InterActive SMARTBase Abutments (K181359) | Primary Predicate: InterActive Engaging Abutments(K143011) | Reference Device: InterActive Non-Engaging Abutments (K130572) | Reference Device: Sirona Dental CAD/CAM-System (K111421) | Reference Device: 3Shape Abutment Designer™ Software (K151455) | | General Design | Abutment body consisting of a titanium base and supplied with a fixation screw. The bases are provided with straight, angled, and modified zirconia tops for patient specific devices. The devices are also provided without a zirconia top and a superstructure or hybrid crown or bridge can be milled to fit the bases intended to be manufactured at Implant Direct Manufacturing facility. | Abutment body consisting of a titanium base and supplied with a fixation screw. The bases are provided with straight, angled, or a modified top intended to be manufactured at Implant Direct Manufacturing facility. | Abutment body consisting of a titanium base and supplied with a fixation screw. The bases are provided without a restoration. | The TiBase is a premanufactured prosthetic component directly connected to endosseous dental implants with a screw and is intended for use as an aid in prosthetic rehabilitation. | N/A | | Abutment Angle | 0° to 30° | 0° to 30° | 0° to 30° | 0° to 20° | N/A | | Restoration | Single Unit, Multi-Unit | Single Unit, Multi-Unit | Multi-Unit | Single Unit, Multi-Unit | N/A | | Post Height | Single Unit - Minimum 4 mm Multi-Unit - Minimum 4 mm | Single Unit - Minimum 4 mm Multi-Unit - Minimum 4 mm | Minimum of 4mm height required | Minimum 4mm | N/A | | Anti-Rotation Feature | Single Unit - One Flat Multi-Unit - One Flat | Single Unit - Three Vertical Grooves at 120° Multi-Unit - One Anti-Rotation Key | Multi-Unit - One Flat | Single anti-rotation feature | N/A | | Prosthesis Attachment | Screw Retained | Screw or Cement Retained | Acrylic | Screw or Cement Retained | N/A | | Screw Thread | M1.6, M2 | M1.6, M2 | M1.6, M2 | M1.6, M2 (NobelActive) | N/A | | Technological Characteristics | Proposed Device: InterActive SMARTBase Abutments (K181359) | Primary Predicate: InterActive Engaging Abutments(K143011) | Reference Device: InterActive Non-Engaging Abutments (K130572) | Reference Device: Sirona Dental CAD/CAM-System (K111421) | Reference Device: 3Shape Abutment Designer™ Software (K151455) | | Interface Platform | 3.0mm and 3.4mm Platform | 3.0mm and 3.4mm Platform | 3.0mm and 3.4mm Platform | NobelActive, NP and RP…