The Universal Base Conical Connection is a premanufactured prosthetic component directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. The Universal Base Conical Connection consists 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 Conical Connection is a dental implant abutment intended to be used with the current Nobel Biocare dental implants that have the existing conical connections.

The Universal Base Conical Connection 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 Conical Connection 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 Conical Connection is made of titanium vanadium alloy.

AI/ML Overview

The provided text describes the Universal Base Conical Connection (CC) dental implant abutment and its equivalence to a predicate device, Nobel Biocare Universal Base Abutment (K180899). The text focuses on establishing substantial equivalence through mechanical, biocompatibility, software, and sterilization testing, rather than an AI-driven diagnostic device requiring extensive clinical studies with ground truth.

Therefore, many of the requested categories related to AI performance, such as sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC comparative effectiveness, and training set details, are not applicable to this document. The document describes a traditional medical device (dental implant abutment) and its performance through engineering and manufacturing validation rather than a diagnostic algorithm.

Here's a summary of the information that is applicable from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several performance tests indirectly through compliance with standards. Explicit numerical acceptance criteria are not detailed in a separate table, but compliance with ISO standards and other tests serves as the acceptance criteria.

Parameter	Acceptance Criteria (Implied)	Reported Device Performance
Dynamic Fatigue	Compliance with ISO 14801: "Dentistry - Implants - Dynamic loading test for endosseous dental implants"	Demonstrated compliance with minimum required fatigue properties.
Biocompatibility	Compliance with ISO 10993-1: "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process"	Successfully conducted Cytotoxicity and Chemical Characterization tests.
Software Verification & Validation	Demonstrated that software restrictions prevent design outside limitations; established design limitations are locked and cannot be modified.	Validation completed with 3Shape TRIOS Scanner, 3Shape Abutment Designer Software (K155415), CORTEC imes-icore milling unit workflow. Design libraries were validated.
Sterilization Validation	Compliance with AAMI-TIR30, ISO 17665-1, and ISO 17665-2.	Steam sterilization analysis performed, device provided non-sterile with instructions for end-user sterilization.
Packaging	Not a new worst case in terms of device packaging and shelf life compared to predicate.	Packaging is the same as the predicate (thermoform tray with peel-top lid). No additional testing required.
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	Not explicitly stated as "passed" for all, but adherence to these specifications is implied by the product description and intended use.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated for each test, but standard test sizes as mandated by the referenced ISO standards would have been used. For example, ISO 14801 for dynamic fatigue testing of dental implants typically involves a specific number of samples (e.g., typically 5-10 samples per test group in some variations).
Data Provenance: The tests are described as performance testing submitted in this 510(K) to support substantial equivalence, indicating they are internal validation studies performed by or for Nobel Biocare AG. No specific country of origin for the data or whether it was retrospective/prospective is mentioned, but typical medical device testing is prospective and conducted at qualified labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a component of a dental implant system, and its performance evaluation relies on engineering tests and compliance with recognized standards, not on expert interpretation of diagnostic images or clinical outcomes for establishing ground truth in the context of an AI algorithm.

4. Adjudication method for the test set

Not applicable for the reasons stated above.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers) and is not applicable to a dental implant abutment.

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

Not applicable. This device is a physical medical component, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by:

Engineering measurements and material properties for mechanical strength and structural integrity.
Chemical and biological assays for biocompatibility.
Software validation logs and functional testing for software components.
Sterilization cycle validation for sterile claim (or user sterilization instructions).
Adherence to specified design parameters (e.g., angles, wall thickness).

8. The sample size for the training set

Not applicable. This device is not an AI algorithm.

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

Not applicable. This device is not an AI algorithm.

Summary

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March 30, 2020

Nobel Biocare AG Bernice Jim Regulatory Affairs Manager Balz Zimmermann-Strasse 7 8302 Kloten, Zurich SWITZERLAND

Re: K200040

Trade/Device Name: Universal Base Conical Connection (CC) Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA PNP Dated: December 18, 2019 Received: January 13, 2020

Dear Bernice Jim:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K200040

Device Name Universal Base Conical Connection (CC)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

|X 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 Services AG Balz Zimmermann-Strasse 7 8302 Kloten, Switzerland 92887

Contact Person: Bernice Jim, Ph.D., Regulatory Affairs Manager E-Mail: bernice.jim@nobelbiocare.com Phone: (+41) 79 855 00 73 Fax: (+41) 43 211 42 42

Date Prepared: March 30, 2020

II. DEVICE

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

III. PREDICATE DEVICE Primary Predicate K180899, Nobel Biocare Universal Base Abutment

IV. REFERENCE DEVICE

Reference Device K151455, 3Shape A/S - 3Shape Abutment Designer Software K153645, Vita Zahnfabrik H. Rauter GmbH Co - Vita Enamic® Implant Solutions (IS) K130436, Multilink Hybrid Abutment Cement - Ivoclar Vivadent, Inc.

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v. DEVICE DESCRIPTION

The Universal Base Conical Connection is a dental implant abutment intended to be used with the current Nobel Biocare dental implants that have the existing conical connections.

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: VITA ENAMIC Implant Solutions (IS) (Vita Zahnfabrik H. Rauter GmbH Co) K153645 - Milling Unit: CORiTEC, imes-icore milling unit

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 12x14x18mm EM-10 blank8x10x15mm

The following restorative design specifications is required:

VI.INDICATIONS FOR USE

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VII. Comparison of Technological Characteristics

Technologicalcharacteristics		Subject Device	Primary Predicate
		Universal Base ConicalConnection	Universal Base Abutment(K180899)
Design Features	CompatibleImplantPlatform	Nobel BiocareInternal Conical ConnectionNarrow Platform (NP)Regular Platform (RP)Wide Platform (WP)	Nobel BiocareExternal HexNarrow Platform (NP)Regular Platform (RP)Wide Platform (WP)
	Ti-baseMaterial	Titanium vanadium alloy(ASTM F136)	Titanium vanadium alloy(ASTM F136)
	Mesostructure/Crown Material	VITA ENAMIC ImplantSolutions (IS)(K153645)	VITA ENAMIC ImplantSolutions (IS) (K153645)
	AbutmentDesign	2 piece - VITA ENAMICIS(K153645) bonded toUniversal Base Abutmentmounted on to the implant andfixed with a screw	2 piece - VITA ENAMIC IS(K153645) bonded to UniversalBase Abutment mounted on tothe implant and fixed with ascrew
	AbutmentFixation	Screwed	Screwed
	MaximumAbutmentAngulation	20°	20°
	DesignWorkflow	3Shape intra oral scanner Trios(3Shape A/S), 3ShapeAbutment Designer Software(3Shape A/S) - K151455	3Shape intra oral scanner Trios(3Shape A/S), 3ShapeAbutment Designer Software(3Shape A/S) - K151455
	ManufacturingWorkflow	CORITEC milling unit (imes-icore)Traditional workflow	CORITEC milling unit (imes-icore)Traditional workflow
	MechanicalTesting	Dynamic FatigueTesting per ISO 14801	Dynamic FatigueTesting per ISO14801
Intended Use		The Universal Base ConicalConnection are attached toNobel Biocare dental implantsand are intended to support acrown.	The Universal Base Abutmentsare attached to Nobel Biocaredental implants and areintended to support a crown.
Technologicalcharacteristics	Subject DeviceUniversal Base ConicalConnection	Primary PredicateUniversal Base Abutment(K180899)
Indications for Use	The Universal Base ConicalConnection is premanufacturedprosthetic components directlyconnected to endosseousdental implants and areintended for use as an aid inprosthetic rehabilitation. TheUniversal Base Abutmentsconsist of two majorparts. Specifically, the titaniumbase and mesostructurecomponents make up a two-piece abutment. The systemintegrates multiple componentsof the digital dentistry workflow:scan files from Intra-OralScanners, CAD software, CAMsoftware, ceramic material,milling machine and associatedtooling and accessories.	The Universal Base Abutmentsare premanufactured prostheticcomponents directly connectedto endosseous dental implantsand are intended for use as anaid in prosthetic rehabilitation.The Universal Base Abutmentsconsist of two majorparts. Specifically, the titaniumbase and mesostructurecomponents make up a two-piece abutment. The systemintegrates multiple componentsof the digital dentistry workflow:scan files from Intra-OralScanners, CAD software, CAMsoftware, ceramic material,milling machine and associatedtooling and accessories.

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Analysis of Differences Between Subiect Device and Predicate

The Universal Base Conical Connection and predicate device, Universal Base Abutment are both abutment systems intended to fit the Nobel Biocare dental implants. Both systems consist of a titanium abutment component and a mesostructured composed of VITA ENAMIC Implant Solutions (IS) (K153645) material. Furthermore, both systems feature a screwed abutment fixation which allows for a maximum abutment angulation correction of 20 degrees.

Discussion about the differences between the subject device and predicate is provided below.

Design Feature - Compatible Implant Platform

The subject device differs from the predicate device in the compatible implant platform, the subject device is designed to be compatible with the internal connection implants. The predicate device is compatible with the implant connection external hex only. To facilitate the connection with the conical connection implants the lower portion of the universal abutment has been modified and differs from the predicate, these modifications are discussion further below. The post portion of the abutment remains the same as the predicate. All other features of the abutment are the same as the predicate, Universal Base Abutment (K180899).

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Differences:

Connection Shape: The subject device has a cone shape which extends into a hexagon shape at the apex of the abutment. The predicate has a hexagon shape at the apex of the abutment. The shape change facilitates the compatibility with the conical connection implant.

Abutment/Implant connection type: For the conical connection, the abutment is the male, the implant is the female connection, for the predicate, the abutment is the female connection and the implant is the male.

Summary:

The design differences between the subject and predicate device do not raise different questions of safety or effectiveness compared to the predicate. Differences in technology were evaluated through performance testing.

VIII. PERFORMANCE DATA

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

Mechanical Testing

Worst case dynamic fatigue testing per ISO 14801:"Dentistry - Implants - Dynamic loading test for endosseous dental implants" was performed and demonstrated compliance with the minimum required fatigue properties of the Universal Base Abutment conical connection with a bonded VITA ENAMIC IS mesostructure.

Biocompatibility Testing

The biocompatibility evaluation for the Universal Base Conical Connection was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

. Cytotoxicity
Chemical Characterization .

The Universal Base Conical Connection is categorized as a long term, implant device with tissue bone contact according to ISO 10993-1. The Universal Base Conical Connection is made of titanium vanadium alloy (ASTM F136).

Software Verification and Validation

Validation was completed on the Universal Base Conical Connection with the 3Shape TRIOS Scanner, 3Shape Abutment Designer Software (K155415), CORTEC 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 Designer TM Software (K151455). Software verification and validation testing was conducted to demonstrate that

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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.

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.

IX. CONCLUSIONS

The Universal Base Conical Connection was evaluated for substantial equivalence using standard and/or comparative testing. In cases were the Universal Base Conical Connection 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 Conical Connection has been shown to be substantially equivalent to the predicate.

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.)