Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.

All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

Device Description

This submission includes the Titanium Base abutments (two-piece hybrid abutments) and the superstructures that compose the final abutment (the second part of the two-piece abutment).

The Titanium Base abutments are provided in two prosthetic platform diameters (3.5 and 4.5 mm), each in five gingival heights (0.8, 1.5, 2.5, 3.5 and 4.5 mm). They have a Morse taper implant-to-abutment interface and an additional hexagonal indexing feature at the apical end of the Morse taper connection. The surface is as-machined, without any type of treatment surface. The Titanium Base abutment is an intermediary prosthetic component between the implant and prosthesis; a CAD/CAM abutment design to be used as a base when fabricating a coping, crown or bridge superstructure. It is a stock abutment, previously cleared per K150367. The subject abutments are compatible with Neodent dental implants having Morse taper (CM) implant-to-interface cleared under K101945, K123022, K133592, K133592, K150182 and K150199.

The purpose of this submission is to expand the range of materials allowed in fabricating the superstructure, adding Co-Cr and IPS e.max "CAD materials to the previously cleared portfolio.

A dental laboratory equipped with an appropriate CAD system, will design a customized superstructure or restoration made of zirconia, IPS e.max CAD or Co-Cr. Each patient-specific superstructure is individually prescribed by the clinician. The minimum wall thickness of the structure is variable depending on the material, according to the table below. The maximum angling of the structure should not exceed 30°. The taper of the structure should not exceed 6°. In the case of a structure angled at the height of the cementable portion starting at the emergence profile (prosthetic height), it should not exceed 10 mm for the Morse Taper.

AI/ML Overview

The provided text is a 510(k) Pre-Market Notification for a medical device (Neodent Implant System - Titanium Base Abutment) to the FDA. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, it does not describe an acceptance criteria table related to performance metrics for a study outcome using accuracy, sensitivity, or specificity, nor does it provide a study that proves the device meets such criteria in the context of an AI/ML or diagnostic device.

The document focuses on demonstrating that the new features of the Neodent Implant System (specifically, the expanded range of materials for superstructures: Co-Cr and IPS e.max CAD) are substantially equivalent to a previously cleared predicate device. The performance data presented are primarily engineering and sterilization validations, not clinical or diagnostic performance metrics.

Therefore, for aspects related to acceptance criteria and studies demonstrating device performance typically associated with AI/ML or diagnostic devices (such as sensitivity, specificity, or accuracy with ground truth validation), the information is not present in the provided text.

Here's an analysis of the information that is available based on your request:

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

No such table is provided in the document for performance metrics like accuracy, sensitivity, or specificity. The "acceptance criteria" for this submission are related to demonstrating substantial equivalence through:

Identical Indications for Use (with minor wording differences considered equivalent)
Identical Mechanical Design Parameters (Abutment Diameter(s), Implant-to-Abutment Connection, Compatibility, Mode of attachment, Restoration Angulation(s), Gingival Height(s))
Identical Abutment Material (Titanium-aluminum-vanadium alloy Ti-6Al-4V)
Equivalent Superstructure Materials (Addition of Co-Cr and IPS e.max CAD, arguing equivalence based on widespread dental use and existing predicate devices)
Identical Sterility and Sterilization by End User

The reported device performance primarily revolves around non-clinical testing to support mechanical integrity, sterilization effectiveness, and biocompatibility.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Summary from document)
Mechanical Strength & Durability	Performed per ISO 14801; compliant with FDA Guidance.
Ethylene Oxide Sterilization	Validation per ISO 11135.
Steam Sterilization by End User	Validation per ISO 17665 series standards.
Biocompatibility	Supported by identical titanium base material to predicate and superstructure materials identical to reference predicates.
Material Properties (Superstructure)	Co-Cr and IPS e.max CAD are widely used in dental restorations and are used in Straumann reference predicates.

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

This information is not provided in the document. The document refers to "engineering analysis, and dimensional analysis" and "mechanical testing," "sterilization validation." These are typically laboratory-based tests with specific sample sizes for specimens, but these details are not disclosed. No patient data (test set) is mentioned.

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 information is not applicable as there is no diagnostic test set or ground truth established by experts described in this document. The submission is for a dental implant abutment, not an AI/ML or diagnostic device requiring expert interpretation of results.

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

This information is not applicable as there is no diagnostic test set or adjudication process described.

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

This information is not applicable as the device is a dental implant abutment, not an AI-assisted diagnostic or imaging interpretation device.

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

This information is not applicable as the device is a physical medical device (dental implant abutment), not an algorithm or software.

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

This information is not applicable as there is no ground truth, expert consensus, pathology, or outcomes data used for performance evaluation in the context of diagnostic accuracy. The "ground truth" for this device's performance would be the physical properties and material specifications, which are assessed through engineering and bench testing.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI/ML model that requires a training set.

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

This information is not applicable as this is a physical medical device, not an AI/ML model.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 15. 2016

JJGC Indústria e Comércio de Materiais Dentários SA c/o Ms. Jennifer Jackson Head of Quality and Regulatory Straumann USA, LLC 60-100 Minuteman Road Andover, Massachusetts 01810

Re: K153624

Trade/Device Name: Neodent Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 15, 2016 Received: March 17, 2016

Dear Ms. Jackson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Erin | Keith -S

Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K153624

Device Name

Neodent Implant System

Indications for Use (Describe)

All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

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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510(k) Summary

Submitter	Straumann USA, LLC60 Minuteman RoadAndover, MA 01810Registration No.: 1222315Owner/Operator No.: 9005052
	on behalf of:
	JJGC Indústria e Comércio de Materiais Dentários SA Av. JuscelinoKubitschek de Olivera, 3291Curtiba, Parana, BRAZIL 81270-200Registration No.: 3008261720Owner/Operator No.: 10031702
Contact Person	Jennifer M. Jackson, MSHead of Quality and Regulatory, Straumann USATelephone (978) 747-2509
Date Prepared	15/April/2016
Prepared by	Ana Carolina Martins ViannaRegulatory Affairs Analyst, JJGC Indústria e Comércio de MateriaisDentários SAavianna@neodent.com.br
Product Code	NHA (21 CFR 872.3630)
Device Class	II (21 CFR 872.3630)
Classification Panel	Dental
Classification Name	Endosseous dental implant abutment (21 CFR 872.3630)
Common Name	Endosseous dental implant abutment
Proprietary name	Neodent Implant System
Primary Predicate	K150367 - Neodent Implant System, JJGC Indústria e Comércio deMateriais Dentários SA
Reference Predicates	K120822 - Straumann® CARES® Variobase™ Abutments, InstituStraumann AGK142890 - Straumann® CARES® Variobase™ Abutments, InstitutStraumann AG

Device Description

This submission includes the Titanium Base abutments (two-piece hybrid abutments) and the superstructures that compose the final abutment (the second part of the two-piece abutment).

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surface. The Titanium Base abutment is an intermediary prosthetic component between the implant and prosthesis; a CAD/CAM abutment design to be used as a base when fabricating a coping, crown or bridge superstructure. It is a stock abutment, previously cleared per K150367. The subject abutments are compatible with Neodent dental implants having Morse taper (CM) implant-to-interface cleared under K101945, K123022, K133592, K150182 and K150199.

The purpose of this submission is to expand the range of materials allowed in fabricating the superstructure, adding Co-Cr and IPS e.max "CAD materials to the previously cleared portfolio.

Material	Minimum thickness (mm)
CoCr	0.3
Zirconia	0.5
IPS e.max	0.6

The planning of the customized superstructures must be made using the validated Dental Wings Operating System (DWOS) or 3Shape software. All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

Indications for Use

All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

Technological Characteristics

The Titanium Base abutment is a two-piece abutment consisting of a pre-manufactured (stock) abutment made of titanium alloy conforming to ASTM F136 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), and a customized superstructure made of ceramics (zirconia or IPS e.max CAD) or Co-Cr. A dental laboratory equipped with an appropriate CAD system, will design a customized superstructure or restoration, which must be milled at a Straumann validated milling center.

The following table shows a comparison among the features of subject device and its predicate and reference devices. The assessment of the differences is also included.

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	SUBJECT DEVICE	PRIMARY PREDICATE
	Neodent Implant System	Neodent Implant System(K150367)	EQUIVALENCE DISCUSSION
Indications for Use	Titanium Base Abutment is a titanium baseplaced onto Neodent dental implants toprovide support for customized prostheticrestorations. It is used with a coping andcrown, or crown alone, and is indicated forcement-retained single or multi-unitrestorations, or screw-retained singlerestorations.All digitally designed copings and/orcrowns for use with the Neodent TitaniumBase Abutment System are intended to besent to Straumann for manufacture at avalidated milling center.	Titanium Base Abutment is a titanium baseplaced onto Neodent dental implants toprovide support for customized prostheticrestorations. It is used with a coping andcrown, or crown alone, and is indicated forcement-retained single or multi-unitrestorations, or screw-retained singlerestorations.	EquivalentThe basic indication of providing supportfor prostheses is identical. Additionalwording was added to the indications tosupport the titanium base abutmentsmanufacturing process. The subjectdevice and primary predicate haveslightly different Indications for Uselanguage. However, the difference inlanguage does not change the intendeduse or substantial equivalence.
Abutment Diameter(s)	3.5 and 4.5 mm	3.5 and 4.5 mm	Identical
Implant-to-AbutmentConnection	Morse taper (CM) interface	Morse taper (CM) interface	Identical
Compatibility	Morse taper (CM) implant lines of NeodentImplant System.	Morse taper (CM) implant lines of NeodentImplant System.	Identical
Mode of attachment	Screw-retained or cementretained	Screw-retained or cementretained	Identical
RestorationAngulation(s)	Up to 30°	Up to 30°	Identical
Gingival Height(s)	0.8, 1.5, 2.5, 3.5 and 4.5mm	0.8, 1.5, 2.5, 3.5 and 4.5mm	Identical
Material of abutment	Titanium-aluminum-vanadium alloy Ti-6Al-4V	Titanium-aluminum-vanadium alloy Ti-6Al-4V	Identical

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	SUBJECT DEVICE	PRIMARY PREDICATE	EQUIVALENCE DISCUSSION
	Neodent Implant System	Neodent Implant System(K150367)
Material ofsuperstructure	ZirconiaCo-CrIPS e-max CAD	Zirconia	EquivalentAddition of IPS e.max CAD and CoCrmaterials does not change the IndicationsFor Use. These materials are used widelyfor dental restorations, including with theStraumann Variobase devices identified asreference devices to this submission.
Sterility	Delivered sterile by EO exposure. To besterilized by user after the copingcementation, before placed in patientmouth.	Delivered sterile by EO exposure. To besterilized by user after the copingcementation, before placed in patientmouth.	Identical
Sterilization by enduser	Moist steam sterilization	Moist steam sterilization	Identical

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Performance data

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include engineering analysis, and dimensional analysis. Testing submitted or referenced in this submission in support of a substantial equivalence determination is as follows:

. Mechanical testing was performed on the Titanium Base abutments including the superstructures according to ISO 14801 - Dentistry - Implants - Dynamic fatigue test for endosseous dental implants and FDA document Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments dated May 12, 2004
. Ethylene Oxide sterilization validation per ISO 11135
. Steam sterilization validation per the ISO 17665 series standards
. Biocompatibility is supported as the material of the titanium base is identical to the company's own predicate. In addition, the materials for construction of the superstructure are identical to Straumann reference predicates and manufactured at a Straumann validated milling center.
. Clinical data were not submitted in this premarket notification.

Conclusions

Based upon our assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate devices and do not raise new issues of safety and effectiveness when uses as labeled.

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.)