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 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.

AI/ML Overview

This document describes the Universal Base Abutment, a dental implant abutment. The information provided outlines the device's technical specifications, comparisons with predicate devices, and performance data from various tests. However, it does not include specific acceptance criteria with numerical targets for clinical performance, nor does it detail a study proving the device meets those specific acceptance criteria in the context of clinical accuracy or diagnostic efficacy.

Therefore, the following information is extracted based on the provided text, and points that cannot be addressed due to the nature of the document (a 510(k) summary for a dental abutment, not an AI/diagnostic device) are explicitly stated as "Not Applicable".

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical medical device (dental abutment) and not an AI or diagnostic device, the acceptance criteria are based on mechanical and biological safety and performance, not on diagnostic accuracy metrics like sensitivity, specificity, or AUC. The "performance" reported is related to adherence to established standards for dental implants and abutments.

Acceptance Criteria Category	Specific Criteria (Implicit or Explicit from Text)	Reported Device Performance and Compliance
Mechanical Performance	Dynamic fatigue testing per ISO 14801 (sufficient fatigue properties compared to predicate)	"Worst case dynamic fatigue testing per ISO 14801 demonstrating compliance with the minimum required fatigue properties of the Universal Base Abutment with a bonded Enamic mesostructure. Results confirmed that the proposed Universal Base Abutments were equivalent to the predicate devices."
Biocompatibility	Biological evaluation according to ISO 10993-1. Cytotoxicity (ISO 10993-5). GC-MS for leachables/extractables (CEN EN ISO 10993-12, CEN EN ISO 10993-18)	"Biological evaluation was conducted according to ISO 10993-1. Cytotoxicity testing per ISO 10993-5 was conducted on the finished devices. GC-MS analysis was performed to gualify any orqanic leachables/ extractables according to CEN EN ISO 10993 12 and CEN EN ISO 10993-18. Results indicate that the devices met biocompatibility requirements for its intended use."
Software V&V	Validation of workflow (scanner, software, milling unit). Verification of design restrictions. Validation of encrypted library to prevent modification.	"Validation was completed on the Universal Base Abutment with the 3Shape TRIOS Scanner, 3Shape Abutment Designer Software (K155415), CORiTEC imes-icore milling unit workflow. Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the 3Shape Abutment DesignerTM Software (K151455). Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the mesostructure component outside of design limitations, including screenshots under user verification testing. In addition, the encrypted abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified within the abutment design library."
Sterilization	Steam sterilization analysis following AAMI-TIR30, ISO 17665-1, and ISO 17665-2 for non-sterile devices.	"Steam sterilization analysis was performed following AAMI-TIR30, ISO 17665-1, and ISO 17665-2."
Device Packaging	Packaging and shelf life performance (comparable to predicate)	"The packaging for the subject device is the same as the predicate. This is a thermoform tray with peel top lid. Therefore, no additional testing was required."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated in terms of a "test set" for clinical performance. The mechanical testing (dynamic fatigue) would have used a sample size determined by ISO 14801 standards (e.g., typically N=10 or more per group for fatigue testing), but this is not a diagnostic test set.
Data Provenance: Not applicable in the context of clinical patient data for a diagnostic device. The testing described (mechanical, biocompatibility, software V&V) is laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This device is a dental abutment, not an AI or diagnostic device that requires expert ground truth for image interpretation or diagnosis. Ground truth in this context relates to engineering standards and material science.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are typically used in clinical studies for diagnostic accuracy to reconcile conflicting expert opinions. This document describes non-clinical, laboratory-based performance testing against ISO standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a dental abutment, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a dental abutment. While there is "Software Verification and Validation" for the design library to ensure it prevents designs outside limitations, this is about the design tool's functionality, not about an AI algorithm's standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's evaluation is based on established international standards for medical device performance (e.g., ISO 14801 for dynamic fatigue, ISO 10993 for biocompatibility) and engineering specifications for the CAD/CAM workflow.

8. The sample size for the training set

Not Applicable. This device submission does not describe an AI algorithm that requires a training set. The software mentioned (3Shape Abutment Designer Software) is a CAD/CAM design tool, not a machine learning model.

9. How the ground truth for the training set was established

Not Applicable. As no AI training set is described, this question is not relevant.

Summary

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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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 (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

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Indications for Use

510(k) Number (if known) K180899

Device Name Universal Base Abutment

Indications for Use (Describe)

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

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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: (714) 282-4800 x 7830 Fax: (714) 998-9348

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.

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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 theimplant	20° Max
Wall Thickness Circular	0.8mm min.
Wall Thickness Margin	0.275mm min.
Post Height	5.2mm min.
Maximum Length, width andHeight	EM-14 blank 12x14x18mmEM-10 blank 8x10x15mm

The following restorative design specifications is required:

V. INDICATIONS FOR USE

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

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VI. Comparison of Technological Characteristics

Technologicalcharacteristics	Subject Device	Primary Predicate	Reference Device	Reference Device	Reference Device
	Universal Base Abutment	Esthetic Zirconia Abutment(K031719)	VITA ENAMIC IS(K153645)	Sirona Dental CAD/CAM-System (K111421)	InterActive SMARTBaseAbutments(K181359)
	CompatibleImplantPlatform	Nobel BiocareExternal HexNarrow Platform (NP)Regular Platform (RP)Wide Platform (WP)	Nobel BiocareInternal Tri -ChannelNarrow Platform (NP)Regular Platform (RP)Wide Platform (WP)External HexNarrow Platform (NP)Regular Platform (RP)Wide Platform (WP)	Nobel BiocareInternal Tri-ChannelNarrow Platform (NP)Regular Platform (RP)Wide Platform (WP)6.0External HexNarrow Platform (NP)Regular Platform (RP)Internal Conical ConnectionNarrow Platform (NP)Regular Platform (RP)and Table 1 of K153645	The InCoris mesostructureand TiBase two-pieceabutment is compatible withthe following implantsystems: Nobel BiocareReplace (K020646), NobelBiocare Branemark(K022562), Friadent Xive(K013867), Biomet 3iOsseotite (K980549), AstraTech Osseospeed(K091239), Zimmer TaperedScrew-Vent (K061410),Straumann Synocta(K061176), Straumann BoneLevel (K053088), Biomet 3iCertain (K014235), NobelBiocare Active (K071370).	InterActive SMARTBaseabutments are compatible atthe implant level withInterActive (3.0mm and3.4mm Platform) andSwishActive (3.0mm and3.4mm Platform) systemimplants.
Design Features	Ti-baseMaterial	Titanium vanadium alloy(ASTM F136)	Metal adapter for InternalTri-Channel: CP titaniumgrade 1 (ASTM F67)	Titanium vanadium alloy(ISO 5832-3)	Tibase - Titanium 6AL4V	Titanium
	Mesostructure/CrownMaterial	Enamic (K153645)	Y-TZP zirconium oxide (ISO13356)	VITA ENAMIC IS, identical incomposition to Enamic(K153645)	Cercon HT	Zenostar MT
	AbutmentDesign	2 piece - Enamic(K153645) bonded toUniversal Base Abutmentmounted on to the implantand fixed with a screw	External Hex: Single piecewith fixed upper shapeInternal Tri-Channel: Singlepiece with fixed upper shapeand Metal adapter	2 piece - VITA ENAMIC ISbonded to Sirona TiBase(K111421) mounted on tothe implant and fixed with ascrew	The TiBase is apremanufactured prostheticcomponent directlyconnected to endosseousdental implants with a screwand is intended for use as anaid in prostheticrehabilitation.	Abutment body consisting ofa titanium base and suppliedwith a fixation screw. Thebases are provided withstraight, angled, andmodified zirconia tops forpatient specific devices. Thedevices are also providedwithout a zirconia top and asuperstructure or hybridcrown or bridge can bemilled to fit the basesintended to be manufactured
Technologicalcharacteristics	Subject Device	Primary Predicate	Reference Device	Reference Device	Reference Device
	Universal Base Abutment	Esthetic Zirconia Abutment(K031719)	VITA ENAMIC IS(K153645)	Sirona Dental CAD/CAM-System (K111421)	InterActive SMARTBaseAbutments(K181359)
	AbutmentFixation	Screwed	Screwed	Screwed	Screw or CementRetained	Screw Retained
	MaximumAbutmentAngulation	20°	No angulation	20°	20°	30°
	DesignWorkflow	3Shape intra oral scannerTrios (3Shape A/S),3Shape AbutmentDesigner Software(3Shape A/S) - K151455	Traditional workflow	Sirona software - inlab 15.0and aboveSirona software - CEREC4.4 and above	Sirona software - inlab 15.0and aboveSirona software - CEREC4.4 and above	3M Tru-Definition, ITeroScanner3Shape Abutment DesignerSoftware (3Shape A/S) -K151455
	ManufacturingWorkflow	CORITEC milling unit(imes-icore)	Traditional workflow	Sirona CEREC millingsystems	Sirona CEREC millingsystems	Wieland-Zenotec Select &Zenotec CAM
	MechanicalTesting	Dynamic FatigueTesting per ISO14801	Dynamic FatigueTesting per ISO14801	Dynamic FatigueTesting per ISO14801	-	Dynamic FatigueTesting per ISO14801
	Subject Device	Primary Predicate	Reference Device	Reference Device	Reference Device
Technologicalcharacteristics	Universal Base Abutment	Esthetic Zirconia Abutment(K031719)	VITA ENAMIC IS(K153645)	Sirona Dental CAD/CAM-System (K111421)	InterActive SMARTBaseAbutments(K181359)
Indications for Use	The Universal BaseAbutments arepremanufacturedprosthetic componentsdirectly connected toendosseous dentalimplants and are intendedfor use as an aid inprosthetic rehabilitation.The Universal BaseAbutments consist of twomajor parts. Specifically,the titanium base andmesostructurecomponents make up atwo-piece abutment.he system integratesmultiple components ofthe digital dentistryworkflow: scan files fromIntra-Oral Scanners, CADsoftware, CAM software,ceramic material, millingmachine and associatedtooling and accessories.	Nobel Biocare's EstheticZirconia Abutment isindicated for the treatment ofpartially edentulous patientsrequiring prosthetic devicesand/or endosseous implantsto restore chewing function	VITA ENAMIC ImplantSolutions is indicated for useas a component of a two-piece abutment system,consisting of a Tibasecomponent, and amesostructure or abutmentcrown. VITA ENAMICImplant Solutions is intendedfor use in partially or fullyedentulous mandible ormaxillae for fabrication ofpermanent, anterior orposterior, single unitCAD/CAM abutments. VITAENAMIC Implant Solutions isindicated for use inconjunction with theCAD/CAM component of theSirona Dental CAD/CAMsystem and the followingTibase abutments andimplant bodies: (Table 1 ofK153645)	The Sirona DentalCAD/CAM System isintended for use in partiallyor fully edentulousmandibles and maxillae insupport of single or multiple-unit cement retainedrestorations. The systemconsists of three major parts:TiBase, InCorismesostructure, andCAD/CAM software.Specifically, the InCorismesostructure and TiBasecomponents make up a two-piece abutment which isused in conjunction withendosseous dental implantsto restore the function andaesthetics in the oral cavity.The InCoris mesostructuremay also be used inconjunction with the CamlogTitanium base CAD/CAM(types K2244.xxxx)(K083496) in the CamlogImplant System. TheCAD/CAM software isintended to design andfabricate the InCorismesostructure.	InterActive/SwishActiveImplant System consists oftwo-piece implants for one-stage or two-stage surgicalprocedures. These implantsare intended for use inpartially and fully edentulousupper and lower jaws insupport of single or multiple-unit restorations and terminalor intermediate SMARTBaseabutment support for fixedbridgework. The systemintegrates multiplecomponents of the digitaldentistry workflow: scan filesfrom Intra-Oral Scanners,CAD software, CAMsoftware, ceramic material, milling machine andassociated tooling andaccessories. TheSMARTBase Abutmentsconsist of two major parts.Specifically, the titaniumbase and zirconia topcomponents make up a two-piece abutment.Implants can be indicated forimmediate loading whengood primary stability hasbeen achieved and withappropriate occlusal loading.Narrow Diameter (3.2,3.3mm) Implants: Indicatedfor single-tooth replacementof mandibular central andlateral incisors and maxillarylateral incisors. Alsoindicated for multiple toothreplacements or denturestabilization.

Nobel Biocare Traditional 510(k) Notification Universal Base Abutment

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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 Platforms

The Universal Base Abutment is designed to connect directly to the Nobel Biocare dental implants. The placement of the Universal Base Abutment takes place after placement of the dental implant. The reference device VITA ENAMIC IS (K153645)

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Ti-base is intended to be connected directly to the implant. Unlike the subject device where it is intended to be used with Nobel Biocare dental implants only, the predicate VITA ENAMIC IS (K153645) is intended to be used with Nobel Biocare dental implants as well as other implants made by non-Vita manufacturers.

Design Workflow

The design and fabrication of the Enamic (K153645) restorations to be bonded to the Universal Base Abutment will be conducted using the following workflow: 3shape TRIOS intraoral scanner, 3Shape Abutment Designer Software (3Shape A/S) - K151455) and a CORiTEC imes-icore milling unit. The reference device InterActive SMARTBase Abutments (K181359) utilizes a different scanner but the same software to design the restoration.

Manufacturing Workflow

The manufacturing of the Enamic (K153645) restorations to be bonded to the Universal Base Abutment will be milled with a CORiTEC imes-icore milling unit. The reference device InterActive SMARTBase Abutments (K181359) utilizes Wieland-Zenotec Select and Zenotec CAM to produce the milled abutment component. The workflow which includes the 3shape TRIOS oral scanner, 3Shape Abutment Designer Software (3Shape A/S) - K151455) and the CORiTEC imes-icore milling machine. The manufacturing workflow differing with the milling unit does not impact demonstrating the substantial equivalence of the subject device to the predicates.

Indications for Use

The intended use for both the subject and predicate device are in the table above. The Universal Base Abutment is a two-piece abutment system, consisting of a titanium premanufactured stock component, and a mesostructure or abutment crown which is designed and fabricated with a CAD/CAM workflow. The reference abutments (K153645 and K181359) are also two-piece abutment systems, consisting of a titanium premanufactured stock component and a mesostructured or abutment crown which is fabricated with a CAD/CAM workflow. The difference does not impact demonstrating the substantial equivalence of the subject device to the predicates.

Summary:

The design differences between the subject and predicates do not raise different questions of substantial equivalence. Differences in technology were evaluated through performance testing.

VII. PERFORMANCE DATA

The following performance testing was submitted in this 510(k) to support substantial equivalence:

Mechanical Testing

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Worst case dynamic fatigue testing per ISO 14801 demonstrating compliance with the minimum required fatigue properties of the Universal Base Abutment with a bonded Enamic mesostructure. Results confirmed that the proposed Universal Base Abutments were equivalent to the predicate devices.

Biocompatibility Testing

Biological evaluation was conducted according to ISO 10993-1. Cytotoxicity testing per ISO 10993-5 was conducted on the finished devices. GC-MS analysis was performed to gualify any orqanic leachables/ extractables according to CEN EN ISO 10993 12 and CEN EN ISO 10993-18. Results indicate that the devices met biocompatibility requirements for its intended use.

Software Verification and Validation

Validation was completed on the Universal Base Abutment with the 3Shape TRIOS Scanner, 3Shape Abutment Designer Software (K155415), CORiTEC imes-icore milling unit workflow. Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the 3Shape Abutment DesignerTM Software (K151455). Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the mesostructure component outside of design limitations, including screenshots under user verification testing. In addition, the encrypted abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified within the abutment design library.

Sterilization Validation

The proposed devices are provided non-sterile and intended to be steam sterilized by the end user. Steam sterilization analysis was performed following AAMI-TIR30, ISO 17665-1, and ISO 17665-2.

Device Packaging

Since the subject device does not represent a new worst case in terms of device packaging and shelf life, data from the predicate was leveraged as follows: The packaging for the subject device is the same as the predicate. This is a thermoform tray with peel top lid. Therefore, no additional testing was required.

VIII. CONCLUSIONS

The Universal Base Abutment was evaluated for substantial equivalence using standard and/or comparative testing. In cases were the Universal Base Abutment could be demonstrated as not to represent the worst-case with respect to the predicates, data from these predicate devices was leveraged to support the subject device. Based on technological characteristics and non-clinical test data included in this submission, the Universal Base Abutment has been shown to be substantially equivalent to the predicates.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)