Universal Base Abutment

K180899 · Nobel Biocare AB · NHA · Oct 31, 2018 · Dental

Device Facts

• Record ID: K180899
• Device Name: Universal Base Abutment
• Applicant: Nobel Biocare AB
• Product Code: NHA · Dental
• Decision Date: Oct 31, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Universal Base Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The Universal Base Abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. 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.

Device Story

Universal Base Abutment is a two-piece dental abutment system consisting of a titanium vanadium alloy base and a CAD/CAM-fabricated mesostructure. Used in a digital dentistry workflow, the device requires input from an intra-oral scanner (e.g., 3Shape TRIOS) and design via CAD software (3Shape Abutment Designer). The clinician uses the CAD software to design a mesostructure within predefined, locked parameters, which is then milled using a CAM unit (e.g., CORiTEC) and bonded to the titanium base. The final assembly is screwed onto existing Nobel Biocare external hex dental implants. The device simplifies the prosthetic design process by providing a known, fixed upper shape for the CAD system. It aids in restoring chewing function and aesthetics for patients with dental implants. The system is intended for use by dental professionals in a clinical setting.

Clinical Evidence

Bench testing only. Evidence includes dynamic fatigue testing per ISO 14801, biocompatibility testing per ISO 10993-5 (cytotoxicity) and ISO 10993-18 (extractables/leachables), and software verification/validation for the CAD/CAM design workflow. Sterilization validation was performed per AAMI-TIR30 and ISO 17665.

Technological Characteristics

Two-piece abutment system; titanium vanadium alloy base; CAD/CAM-milled mesostructure (e.g., Enamic). Compatible with Nobel Biocare external hex implants. Max angulation 20°. Non-sterile, steam-sterilizable by end-user. Software-integrated design library with locked parameters. Materials comply with ASTM F136.

Indications for Use

Indicated for use as an aid in prosthetic rehabilitation for patients requiring prosthetic devices and/or endosseous implants to restore chewing function in partially or fully edentulous jaws.

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

• Nobel Biocare - Esthetic Zirconia Abutment (K031719)

Reference Devices

• Vita Zahnfabrik H. Rauter GmbH Co - Vita Enamic® Implant Solutions (K153645)
• Sirona Dental Systems GmbH – Sirona Dental CAD/CAM System (K111421)
• Implant Direct Sybron Manufacturing Llc - Interactive Smartbase Abutments (K181359)
• 3Shape A/S - 3Shape Abutment Designer Software (K151455)
• Ivoclar Vivadent, Inc. - Multilink Hybrid Abutment Cement (K130436)

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.

November 1, 2018

Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda. California 92887

Re: K180899

Trade/Device Name: Universal Base Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: September 26, 2018 Received: September 27, 2018

Dear Charlemagne Chua:

This letter corrects our substantially equivalent letter of October 31, 2018.

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 ([e-mail]) or phone [phone] 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}------------------------------------------------

## Indications for Use

510(k) Number (if known) K180899

Device Name Universal Base Abutment

#### Indications for Use (Describe)

The Universal Base Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The Universal Base Abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> 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}------------------------------------------------

A.4.

510(k) Summary

I. SUBMITTER

Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden

Submitted by: Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887

Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: [phone] x 7830 Fax: [phone]

Date Prepared: October 25, 2018

II. DEVICE

Name of Device: Universal Base Abutment Common or Usual Name: Endosseous Dental Implant Abutment Classification Name: Endosseous Dental Implant (21 CFR 872.3630) Regulatory Class: II Primary Product Code: NHA Secondary Product Code: PNP

III.PREDICATE DEVICE

Primary Predicate K031719. Nobel Biocare - Esthetic Zirconia Abutment

Reference Devices K153645, Vita Zahnfabrik H. Rauter GmbH Co - Vita Enamic® Implant Solutions (lis) K111421, Sirona Dental Systems GmbH – Sirona Dental CAD/CAM System K181359, Implant Direct Sybron Manufacturing Llc - Interactive Smartbase

Abutments

K151455, 3Shape A/S - 3Shape Abutment Designer Software

K130436. Multilink Hybrid Abutment Cement - Ivoclar Vivadent, Inc.

{4}------------------------------------------------

## IV. DEVICE DESCRIPTION

The Universal Base Abutment is a dental implant abutment intended to be used with the current Nobel Biocare dental implants that have the existing external hex style connections.

The Universal Base Abutment features a fixed upper shape with indexing feature that is intended to serve as the platform for an in-laboratory CAD/CAM system made mesostructure. The fixed upper shape and indexing feature facilitates the use of CAD/CAM systems by providing a known shape that can be imported into the design software, thereby, simplifying the CAD/CAM design process.

The Universal Base Abutment is available for the Nobel Biocare Narrow Platform (NP), Regular Platform (RP) and Wide Platform (WP) for external hex. All sizes are available in either 1.5 or 3mm collar heights. The Universal Base Abutment is made of titanium vanadium alloy.

The digital workflow requires the use of the following equipment:

- Scanner: 3Shape intra oral scanner Trios (3Shape A/S) -
- -Design Software: 3Shape Abutment Designer Software (3Shape A/S) -K151455
- Restorative Material: Enamic (Vita Zahnfabrik H. Rauter GmbH Co) --K153645
- Milling Unit: CORiTEC, imes-icore milling unit -

| Restorative design specifications for Universal Base | |
|------------------------------------------------------|-------------------------------------------------|
| Parameter | Specification |
| Angle from axis of the<br>implant | 20° Max |
| Wall Thickness Circular | 0.8mm min. |
| Wall Thickness Margin | 0.275mm min. |
| Post Height | 5.2mm min. |
| Maximum Length, width and<br>Height | EM-14 blank 12x14x18mm<br>EM-10 blank 8x10x15mm |

The following restorative design specifications is required:

## V. INDICATIONS FOR USE

The Universal Base Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The Universal Base Abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital

{5}------------------------------------------------

dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

{6}------------------------------------------------

# VI. Comparison of Technological Characteristics

| Technological<br>characteristics | Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device | |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Universal Base Abutment | Esthetic Zirconia Abutment<br>(K031719) | VITA ENAMIC IS<br>(K153645) | Sirona Dental CAD/CAM-<br>System (K111421) | InterActive SMARTBase<br>Abutments<br>(K181359) | |
| | Compatible<br>Implant<br>Platform | Nobel Biocare<br>External Hex<br>Narrow Platform (NP)<br>Regular Platform (RP)<br>Wide Platform (WP) | Nobel Biocare<br>Internal Tri -Channel<br>Narrow Platform (NP)<br>Regular Platform (RP)<br>Wide Platform (WP)<br>External Hex<br>Narrow Platform (NP)<br>Regular Platform (RP)<br>Wide Platform (WP) | Nobel Biocare<br>Internal Tri-Channel<br>Narrow Platform (NP)<br>Regular Platform (RP)<br>Wide Platform (WP)<br>6.0<br>External Hex<br>Narrow Platform (NP)<br>Regular Platform (RP)<br>Internal Conical Connection<br>Narrow Platform (NP)<br>Regular Platform (RP)<br>and Table 1 of K153645 | The InCoris mesostructure<br>and TiBase two-piece<br>abutment is compatible with<br>the following implant<br>systems: Nobel Biocare<br>Replace (K020646), Nobel<br>Biocare Branemark<br>(K022562), Friadent Xive<br>(K013867), Biomet 3i<br>Osseotite (K980549), Astra<br>Tech Osseospeed<br>(K091239), Zimmer Tapered<br>Screw-Vent (K061410),<br>Straumann Synocta<br>(K061176), Straumann Bone<br>Level (K053088), Biomet 3i<br>Certain (K014235), Nobel<br>Biocare Active (K071370). | InterActive SMARTBase<br>abutments are compatible at<br>the implant level with<br>InterActive (3.0mm and<br>3.4mm Platform) and<br>SwishActive (3.0mm and<br>3.4mm Platform) system<br>implants. |
| Design Features | Ti-base<br>Material | Titanium vanadium alloy<br>(ASTM F136) | Metal adapter for Internal<br>Tri-Channel: CP titanium<br>grade 1 (ASTM F67) | Titanium vanadium alloy<br>(ISO 5832-3) | Tibase - Titanium 6AL4V | Titanium |
| | Mesostructure<br>/<br>Crown<br>Material | Enamic (K153645) | Y-TZP zirconium oxide (ISO<br>13356) | VITA ENAMIC IS, identical in<br>composition to Enamic<br>(K153645) | Cercon HT | Zenostar MT |
| | Abutment<br>Design | 2 piece - Enamic<br>(K153645) bonded to<br>Universal Base Abutment<br>mounted on to the implant<br>and fixed with a screw | External Hex: Single piece<br>with fixed upper shape<br>Internal Tri-Channel: Single<br>piece with fixed upper shape<br>and Metal adapter | 2 piece - VITA ENAMIC IS<br>bonded to Sirona TiBase<br>(K111421) mounted on to<br>the implant and fixed with a<br>screw | The TiBase is a<br>premanufactured prosthetic<br>component directly<br>connected to endosseous<br>dental implants with a screw<br>and is intended for use as an<br>aid in prosthetic<br>rehabilitation. | Abutment body consisting of<br>a titanium base and supplied<br>with a fixation screw. The<br>bases are provided with<br>straight, angled, and<br>modified zirconia tops for<br>patient specific devices. The<br>devices are also provided<br>without a zirconia top and a<br>superstructure or hybrid<br>crown or bridge can be<br>milled to fit the bases<br>intended to be manufactured |
| Technological<br>characteristics | Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device | |
| | Universal Base Abutment | Esthetic Zirconia Abutment<br>(K031719) | VITA ENAMIC IS<br>(K153645) | Sirona Dental CAD/CAM-<br>System (K111421) | InterActive SMARTBase<br>Abutments<br>(K181359) | |
| | Abutment<br>Fixation | Screwed | Screwed | Screwed | Screw or Cement<br>Retained | Screw Retained |
| | Maximum<br>Abutment<br>Angulation | 20° | No angulation | 20° | 20° | 30° |
| | Design<br>Workflow | 3Shape intra oral scanner<br>Trios (3Shape A/S),<br>3Shape Abutment<br>Designer Software<br>(3Shape A/S) - K151455 | Traditional workflow | Sirona software - inlab 15.0<br>and above<br>Sirona software - CEREC<br>4.4 and above | Sirona software - inlab 15.0<br>and above<br>Sirona software - CEREC<br>4.4 and above | 3M Tru-Definition, ITero<br>Scanner<br>3Shape Abutment Designer<br>Software (3Shape A/S) -<br>K151455 |
| | Manufacturing<br>Workflow | CORITEC milling unit<br>(imes-icore) | Traditional workflow | Sirona CEREC milling<br>systems | Sirona CEREC milling<br>systems | Wieland-Zenotec Select &<br>Zenotec CAM |
| | Mechanical<br>Testing | Dynamic Fatigue<br>Testing per ISO<br>14801 | Dynamic Fatigue<br>Testing per ISO<br>14801 | Dynamic Fatigue<br>Testing per ISO<br>14801 | - | Dynamic Fatigue<br>Testing per ISO<br>14801 |
| | Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device | |
| Technological<br>characteristics | Universal Base Abutment | Esthetic Zirconia Abutment<br>(K031719) | VITA ENAMIC IS<br>(K153645) | Sirona Dental CAD/CAM-<br>System (K111421) | InterActive SMARTBase<br>Abutments<br>(K181359) | |
| Indications for Use | The Universal Base<br>Abutments are<br>premanufactured<br>prosthetic components<br>directly connected to<br>endosseous dental<br>implants and are intended<br>for use as an aid in<br>prosthetic rehabilitation.<br>The Universal Base<br>Abutments consist of two<br>major parts. Specifically,<br>the titanium base and<br>mesostructure<br>components make up a<br>two-piece abutment.<br>he system integrates<br>multiple components of<br>the digital dentistry<br>workflow: scan files from<br>Intra-Oral Scanners, CAD<br>software, CAM software,<br>ceramic material, milling<br>machine and associated<br>tooling and accessories. | Nobel Biocare's Esthetic<br>Zirconia Abutment is<br>indicated for the treatment of<br>partially edentulous patients<br>requiring prosthetic devices<br>and/or endosseous implants<br>to restore chewing function | VITA ENAMIC Implant<br>Solutions is indicated for use<br>as a component of a two-<br>piece abutment system,<br>consisting of a Tibase<br>component, and a<br>mesostructure or abutment<br>crown. VITA ENAMIC<br>Implant Solutions is intended<br>for use in partially or fully<br>edentulous mandible or<br>maxillae for fabrication of<br>permanent, anterior or<br>posterior, single unit<br>CAD/CAM abutments. VITA<br>ENAMIC Implant Solutions is<br>indicated for use in<br>conjunction with the<br>CAD/CAM component of the<br>Sirona Dental CAD/CAM<br>system and the following<br>Tibase abutments and<br>implant bodies: (Table 1 of<br>K153645) | The Sirona Dental<br>CAD/CAM System is<br>intended for use in partially<br>or fully edentulous<br>mandibles and maxillae in<br>support of single or multiple-<br>unit cement retained<br>restorations. The system<br>consists of three major parts:<br>TiBase, InCoris<br>mesostructure, and<br>CAD/CAM software.<br>Specifically, the InCoris<br>mesostructure and TiBase<br>components make up a two-<br>piece abutment which is<br>used in conjunction with<br>endosseous dental implants<br>to restore the function and<br>aesthetics in the oral cavity.<br>The InCoris mesostructure<br>may also be used in<br>conjunction with the Camlog<br>Titanium base CAD/CAM<br>(types K2244.xxxx)<br>(K083496) in the Camlog<br>Implant System. The<br>CAD/CAM software is<br>intended to design and<br>fabricate the InCoris<br>mesostructure. | InterActive/SwishActive<br>Implant System consists of<br>two-piece implants for one-<br>stage or two-stage surgical<br>procedures. These implants<br>are intended for use in<br>partially and fully edentulous<br>upper and lower jaws in<br>support of single or multiple-<br>unit restorations and terminal<br>or intermediate SMARTBase<br>abutment support for fixed<br>bridgework. The system<br>integrates multiple<br>components of the digital<br>dentistry workflow: scan files<br>from Intra-Oral Scanners,<br>CAD software, CAM<br>software, ceramic material, milling machine and<br>associated tooling and<br>accessories. The<br>SMARTBase Abutments<br>consist of two major parts.<br>Specifically, the titanium<br>base and zirconia top<br>components make up a two-<br>piece abutment.<br>Implants can be indicated for<br>immediate loading when<br>good primary stability has<br>been achieved and with<br>appropriate occlusal loading.<br>Narrow Diameter (3.2,<br>3.3mm) Implants: Indicated<br>for single-tooth replacement<br>of mandibular central and<br>lateral incisors and maxillary<br>lateral incisors. Also<br>indicated for multiple tooth<br>replacements or denture<br>stabilization. | |

Nobel Biocare Traditional 510(k) Notification Universal Base Abutment

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

## Analysis of Differences Between Subiect Device and Predicates

The Universal Base Abutment and Esthetic Zirconia Abutment primary predicate (K031719) are intended to be used with the same existing Nobel Biocare dental implant connection external hex style connection. The Universal Base Abutment is a two-piece abutment made of titanium vanadium alloy and Enamic (K153645) while the primary predicate K031719 is a one-piece. composed of zirconium oxide, or two-piece abutment/crown, composed of CP titanium and zirconium oxide, depending on the implant connection.

The Universal Base Abutment and reference device VITA ENAMIC IS (K153645) are both abutment systems intended to fit the Nobel Biocare dental implants. Both systems consist of a titanium abutment component and a mesostructure or abutment crown composed of Enamic (K153645) material. Furthermore, both svstems feature a screwed abutment fixation. The Universal Base Abutment allows for a maximum abutment angulation correction of 20 degrees as the reference device VITA ENAMIC IS (K153645) which also allows for a maximum abutment angulation correction of 20 degrees. Furthermore, both systems are intended for CAD/CAM workflows. The reference device K153645 utilizes the Sirona Dental CAD/CAM-System (K111421) which includes scanner, software and mill to manufacture the Enamic (K153645) mesostructure. The Universal Base Abutment utilizes a 3shape TRIOS intraoral scanner, 3Shape Abutment Designer Software (3Shape A/S) - K151455) and a CORiTEC imes-icore milling unit to produce the mesostructure.

The Universal Base Abutment and reference device InterActive SMARTBase Abutments (K181359) are both abutment systems intended to fit the Nobel Biocare dental implants. The Universal Base Abutment consist of a titanium abutment component and a mesostructure or abutment crown composed of Enamic (K153645) material. The InterActive SMARTBase Abutments (K181359) consists of a titanium abutment component and a mesostrucutre or abutment crown composed of Zirconia. Both systems feature a screwed abutment fixation. The Universal Base Abutment allows for a maximum abutment angulation correction of 20 degrees and the the reference device InterActive SMARTBase Abutments (K181359) allows for svstems are intended for CAD/CAM workflows. The reference device K181359 utilizes the 3M Tru-Definition, ITero Scanner, 3Shape Abutment Designer Software (3Shape A/S) - K151455) and a Wieland-Zenotec Select and Zenotec CAM unit to produce the Zirconia mesostructure. The Universal Base Abutment utilizes the 3shape TRIOS intraoral scanner, 3Shape Abutment Designer Software (3Shape A/S) - K151455) and a CORiTEC imes-icore milling unit to produce the mesostructure.

### Compatible Implant Platfor…