The On1™ device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. The On1 Universal Abutments consist of three major parts. Specifically, the On1 Base, the On1 Universal Abutment, and the mesostructure components make up a multi-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 On1 Universal Abutment is a dental implant abutment which attaches to the On1 Base of the On1 Concept (K161655) and is intended to be used with the current Nobel Biocare dental implants that have the existing internal conical connection.

The On1 Universal Abutment features a fixed upper shape with indexing feature that is intended to serve as the platform for either an in-laboratory CAD/CAM system made mesostructure or abutment crown. 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 On1 Universal Abutment is available for the Nobel Biocare Narrow Platform (NP), Regular Platform (RP) and Wide Platform (WP) for the internal conical connection. The On1 Universal Abutment is made of titanium vanadium alloy.

AI/ML Overview

The document does not detail specific acceptance criteria or a dedicated study proving the device meets those criteria in the traditional sense of a clinical trial or performance study with defined endpoints. Instead, it describes a 510(k) summary for substantial equivalence, which relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The "study" in this context is a series of non-clinical performance tests designed to show that the On1 Universal Abutment performs comparably to its predicate and reference devices, and that any differences do not raise new questions of safety or effectiveness.

Here's the breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for performance in a table format. However, it does list "Restorative design specifications" which act as internal design criteria, and various performance tests that the device successfully met. The key "acceptance criterion" implied throughout the document is "substantial equivalence" to the predicate devices.

Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Performance: - Compliance with minimum required fatigue properties per ISO 14801. - Restorative design specifications: - Angle from axis of the implant: 20° Max - Wall Thickness Circular: 0.8mm min. - Wall Thickness Margin: 0.275mm min. - Post Height: 5.2mm min. - Maximum Length, width and Height: EM-14 blank 12x14x18mm, EM-10 blank 8x10x15mm	Mechanical Performance: - "Worst case dynamic fatigue testing per ISO 14801 demonstrating compliance with the minimum required fatigue properties of the On1 Universal Abutment with a bonded Enamic mesostructure. Results confirmed that the proposed On1 Universal Abutments were equivalent to the predicate devices." - Device design adheres to the listed restorative design specifications.
Biocompatibility: - Compliance with ISO 10993-1, ISO 10993-5 (Cytotoxicity), CEN EN ISO 10993-12, and CEN EN ISO 10993-18 (GC-MS analysis for organic leachables/extractables).	Biocompatibility: - "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... Results indicate that the devices met biocompatibility requirements for its intended use."
Software Verification and Validation: - Restrictions prevent design of mesostructure component outside of design limitations. - Established design limitations and specifications are locked and cannot be modified within the abutment design library.	Software Verification and Validation: - "Validation was completed on the On1 Universal 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). ...testing was conducted to demonstrate that the restrictions prevent design of the mesostructure component outside of design limitations... 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: - Compliance with AAMI-TIR30, ISO 17665-1, and ISO 17665-2 for steam sterilization.	Sterilization Validation: - "Steam sterilization analysis was performed following AAMI-TIR30, ISO 17665-1, and ISO 17665-2."
Device Packaging: - No new worst-case in terms of device packaging and shelf life compared to predicate.	Device Packaging: - "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: The document does not specify the exact sample sizes for the mechanical, biocompatibility, software, or sterilization testing. It refers to "worst case dynamic fatigue testing" and "the finished devices" for biocompatibility without providing numbers.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission from Nobel Biocare AB (Sweden) and Nobel Biocare USA LLC (USA), it's likely the testing was conducted in facilities accustomed to international and US regulatory standards, but specific locations are not mentioned. The nature of the tests (mechanical, biocompatibility, software, sterilization) suggests controlled laboratory experiments, not patient data.

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)

This section is not applicable as the document describes non-clinical performance testing for a dental implant abutment, not a diagnostic or screening device that requires expert-established ground truth from medical images or patient data. The "ground truth" for these tests would be the established international standards (e.g., ISO 14801, ISO 10993 series).

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

This is not applicable for the type of non-clinical performance testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving reader interpretation (e.g., radiologists, pathologists) where discrepancies need to be resolved to establish ground truth for a test set. The tests here are objective engineering and material science evaluations.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study assesses human performance, often in diagnostic tasks, and is not relevant for a dental implant abutment. The device is a physical component, not an AI-powered diagnostic tool.

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

This is not applicable. The device is a physical dental implant abutment, not an algorithm or AI system. Software verification and validation were performed for the accompanying design software, but this is distinct from "standalone algorithm performance" in the context of AI.

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

The "ground truth" for the performance testing described are established international standards and specifications (e.g., ISO 14801 for dynamic fatigue, ISO 10993 series for biocompatibility, AAMI-TIR30, ISO 17665-1/2 for sterilization). For software, the ground truth is the predefined design limitations and specifications that the software must enforce and protect.

8. The sample size for the training set

This is not applicable. The device is a physical component, not an AI model that requires a training set. The descriptions of "design workflow" and "manufacturing workflow" refer to the process by which the abutment is designed and fabricated, not machine learning model training.

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

This is not applicable as there is no training set for an AI model.

Summary

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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 text "U.S. Food & Drug Administration" in blue letters.

December 12, 2018

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

Re: K181869

Trade/Device Name: On1™ Universal Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: November 8, 2018 Received: November 9, 2018

Dear Charlemagne Chua:

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.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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

Tina Kiang, Ph.D. for 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) K181869

Device Name On1™ Univeral Abutment

Indications for Use (Describe)

The Onl™ device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. The Onl Universal Abutments consist of three major parts. Specifically, the On1 Base, the On1 Universal Abutment, and the mesostructure components make up a multi-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)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

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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: December 11, 2018

II. DEVICE

Name of Device: On1TM Universal 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 K161655, Nobel Biocare AB - On1 Concept

Reference Devices K153645, Vita Zahnfabrik H. Rauter GmbH Co - Vita Enamic® Implant Solutions (IS) 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, Ivoclar Vivadent, Inc. - Multilink Hybrid Abutment Cement

IV. DEVICE DESCRIPTION

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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 where the Implant Libraries are obtained via the 3Shape server in the software
-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 implant	20° Max
Wall Thickness Circular	0.8mm min.
Wall Thickness Margin	0.275mm min.
Post Height	5.2mm min.
Maximum Length, width and Height	EM-14 blank 12x14x18mmEM-10 blank 8x10x15mm

The following restorative design specifications is required:

V. INDICATIONS FOR USE

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multi-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.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VI.

Technologicalcharacteristics	Subject Device	Primary Predicate	Reference Device	Reference Device	Reference Device
	On1 Universal Abutment	On1 Concept(K161655)	VITA ENAMIC IS(K153645)	Sirona Dental CAD/CAM-System (K111421)	InterActive SMARTBaseAbutments(K181359)
	CompatibleImplantPlatform	Nobel Biocare InternalConical Connection- Narrow Platform (NP)- Regular Platform (RP)- Wide Platform (WP)	Nobel Biocare InternalConical Connection- Narrow Platform (NP)- Regular Platform (RP)- Wide Platform (WP)	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), ZimmerTapered Screw-Vent(K061410), StraumannSynocta (K061176),Straumann Bone Level(K053088), Biomet 3iCertain (K014235), NobelBiocare Active (K071370).	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), ZimmerTapered Screw-Vent(K061410), StraumannSynocta (K061176),Straumann Bone Level(K053088), Biomet 3iCertain (K014235), NobelBiocare Active (K071370).	InterActive SMARTBaseabutments are compatibleat the implant level withInterActive (3.0mm and3.4mm Platform) andSwishActive (3.0mm and3.4mm Platform) systemimplants.
	Ti/ AbutmentMaterial	On1 Base (K161655), On1Universal Abutment -Titanium vanadium alloy(ASTM F136)	On1 Base, On1 EstheticAbutment Titanium -Titanium vanadium alloy(ASTM F136)On1 Esthetic AbutmentZirconia- Y-TZP zirconium oxide(ISO6872, ISO 13356)	Titanium vanadium alloy(ISO 5832-3)	Tibase - Titanium 6AL4V	Titanium
Design Features	Mesostructure/CrownMaterial	Enamic (K153645)	N/A	VITA ENAMIC IS, identicalin composition to Enamic(K153645)	Cercon HT	Zirconia
	Mesostructure/CrownFixation	Bonded	N/A	Bonded	Bonded	Bonded
	AbutmentDesign	2 piece abutment on On1Base - Enamic (K153645)	1 piece abutment on On1Base - Esthetic Abutment	2 piece - VITA ENAMIC ISbonded to Sirona TiBase	The TiBase is apremanufactured prosthetic	Abutment body consistingof a titanium base and
Technologicalcharacteristics		Subject Device	Primary Predicate	Reference Device	Reference Device	Reference Device
		On1 Universal Abutment	On1 Concept(K161655)	VITA ENAMIC IS(K153645)	Sirona Dental CAD/CAM-System (K111421)	InterActive SMARTBaseAbutments(K181359)
		bonded to the On1Universal Abutment andmounted on to the On1Base (K161655). On1 Baseis mounted on to theimplant and fixed with ascrew.	Titanium is mounted on tothe On1 Base. On1 Base ismounted on to the implantand fixed with a screw.	(K111421) mounted on tothe implant and fixed with ascrew	component directlyconnected to endosseousdental implants with ascrew and is intended foruse as an aid in prostheticrehabilitation.	supplied with a fixationscrew. The bases areprovided with straight,angled, and modifiedzirconia tops for patientspecific devices. Thedevices are also providedwithout a zirconia top and asuperstructure or hybridcrown or bridge can bemilled to fit the basesintended to bemanufactured at ImplantDirect Manufacturingfacility.
	AbutmentFixation	Screwed	Screwed	Screw or CementRetained	Screw or CementRetained	Screw Retained
	MaximumAngulation	20°	0°	20°	20°	30°
	DesignWorkflow	3Shape intra oral scannerTrios (3Shape A/S),3Shape Abutment DesignerSoftware (3Shape A/S) -K151455	Traditional workflow	Sirona software - inlab15.0 and aboveSirona software - CEREC4.4 and above	Sirona software - inlab15.0 and 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	On1 Universal Abutment	On1 Concept(K161655)	VITA ENAMIC IS(K153645)	Sirona Dental CAD/CAM-System (K111421)	InterActive SMARTBaseAbutments(K181359)
Indications for Use	The On1™ device is apremanufactured prostheticcomponent directlyconnected to anendosseous implant and itis intended for use inprosthetic rehabilitation.The On1 UniversalAbutments consist of threemajor parts. Specifically,the On1 Base, the On1Universal Abutment, andthe mesostructurecomponents make up amulti-piece abutment.The system integratesmultiple components of thedigital dentistry workflow:scan files from Intra-OralScanners, CAD software,CAM software, ceramicmaterial, milling machineand associated tooling andaccessories	The On1™ device is apremanufactured prostheticcomponent directlyconnected to anendosseous implant and itis intended for use inprosthetic rehabilitation.	VITA ENAMIC ImplantSolutions is indicated foruse as a component of atwo-piece abutmentsystem, consisting of a Ti-base component, and amesostructure or abutmentcrown. VITA ENAMICImplant Solutions isintended for use in partiallyor fully edentulousmandible or maxillae forfabrication of permanent,anterior or posterior, singleunit CAD/CAM abutments.VITA ENAMIC ImplantSolutions is indicated foruse in conjunction with theCAD/CAM component ofthe Sirona DentalCAD/CAM system and thefollowing Ti-baseabutments and implantbodies: (Table 1 ofK153645)	The Sirona DentalCAD/CAM System isintended for use in partiallyor fully edentulousmandibles and maxillae insupport of single ormultiple-unit cementretained restorations. Thesystem consists of threemajor parts: TiBase,InCoris mesostructure, andCAD/CAM software.Specifically, the InCorismesostructure and TiBasecomponents make up atwo-piece abutment whichis used in conjunction withendosseous dentalimplants to restore thefunction and aesthetics inthe oral cavity. The InCorismesostructure may also beused in conjunction with theCamlog Titanium baseCAD/CAM (typesK2244.xxxx) (K083496) inthe Camlog ImplantSystem. The CAD/CAMsoftware is intended todesign and fabricate theInCoris mesostructure.	InterActive/SwishActiveImplant System consists oftwo-piece implants for one-stage or two-stage surgicalprocedures. These implantsare intended for use inpartially and fullyedentulous upper and lowerjaws in support of single ormultiple-unit restorationsand terminal orintermediate SMARTBaseabutment support for fixedbridgework. The systemintegrates multiplecomponents of the digitaldentistry workflow: scanfiles from Intra-OralScanners, CAD software,CAM software, ceramicmaterial, milling machineand associated tooling andaccessories. TheSMARTBase Abutmentsconsist of two major parts.Specifically, the titaniumbase and zirconia topcomponents make up atwo-piece abutment.Implants can be indicatedfor immediate loading whengood primary stability hasbeen achieved and withappropriate occlusalloading.Narrow Diameter (3.2,3.3mm) Implants: Indicatedfor single-toothreplacement of mandibularcentral and lateral incisorsand maxillary lateralincisors. Also indicated for
Technologicalcharacteristics	Subject Device	Primary Predicate	Reference Device	Reference Device	Reference Device
	On1 Universal Abutment	On1 Concept(K161655)	VITA ENAMIC IS(K153645)	Sirona Dental CAD/CAM-System (K111421)	InterActive SMARTBaseAbutments(K181359)multiple tooth replacementsor denture stabilization.

Nobel Biocare Traditional 510(k) Notification On1 Universal Abutment
December 2018

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Analysis of Differences Between Subiect Device and Predicates

The On1 Universal Abutment is a hybrid abutment which connects to the On1 Base of the On1 Concept (K161655). The intended use remains similar. The On1 Universal Abutment is a multi-piece abutment made of titanium vanadium alloy and Enamic (K153645) while the Esthetic abutments of the On1 Concept (K161655) are one-piece, composed either of zirconium oxide or titanium.

The On1 Universal Abutment and reference device VITA ENAMIC IS (K153645) are both abutment systems intended to fit the Nobel Biocare dental implants. Both svstems 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 On1 Universal 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 On1 Universal 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 On1 Universal Abutment and reference device InterActive SMARTBase Abutments (K181359) are both abutment systems intended to fit the Nobel Biocare dental implants. The On1 Universal 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 On1 Universal 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 On1 Universal 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 On1 Universal Abutment is designed to connect directly to the On1 Base which connects to Nobel Biocare dental implants. The placement of the On1 Universal Abutment takes place after placement of the On1 Base and the dental implant. The

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reference device VITA ENAMIC IS (K153645) 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 On1 Universal 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 On1 Universal 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 On1 Universal Abutment is a multi-piece abutment system, consisting of two titanium premanufactured stock components, and a mesostructure or abutment crown which is designed and fabricated with a CAD/CAM workflow. The reference abutments (K153645 and K181359) are also multi-piece abutment systems. consisting of a titanium premanufactured stock component and a mesostructure 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 On1 Universal Abutment with a bonded Enamic mesostructure. Results confirmed that the proposed On1 Universal 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 On1 Universal 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 On1 Universal Abutment was evaluated for substantial equivalence using standard and/or comparative testing. In cases were the On1 Universal 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 On1 Universal 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.)