The Titanium Base for CEREC is a titanium component that is placed over Neodent Implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for single-tooth screw-retained restorations.

All digitally designed copings and/or crowns for use with the Neodent Titanium Base for CEREC are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

Device Description

The Titanium Base for CEREC consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment.

The Titanium Base for CEREC abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surqical Implant Applications and are provided in a 4.65 mm prosthetic platform diameter and seven gingival heights (0.8, 1.5, 2.5, 3.5, 4.5, 5.5 and 6.5 mm), all having a 4.7 mm prosthetic height. They also feature:

cylindrical shape
hexagonal indexing at the apical end of the Morse taper connection
indexing guide in the cementable portion for coping fitting

The CAD/CAM customized superstructure that composes the final abutment must be designed and milled through the Sirona Dental CAD/CAM System, according to the prosthetic planning and patient clinical situation.

The Titanium Base for CEREC is provided sterile by Ethylene Oxide and steam sterilization is recommended after the cementation of the customized superstructure on the Titanium Base for CEREC.

The Titanium Base for CEREC is compatible with the following devices:

Dental implants
All Neodent dental implants having Morse taper implant-to-abutment interface (CM line) cleared under K101945, K123022, K133592, K150182 and K150199.

Raw material blanks

-InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664;
-IPS e.max CAD Abutments Solutions (LiSi₂) by Ivoclar Vivadent AG, L size blanks, cleared under K132209.

Software
Sirona Dental CAD/CAM System, by Sirona Dental Systems GmbH, cleared under K111421.

Instruments

-Neodent screwdrivers (class I - exempt devices)
Sirona scanbodies (class I exempt devices)

AI/ML Overview

The provided text is a 510(k) premarket notification for the "Neodent Implant System - Titanium Bases For Cerec" and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and proving device performance through a standalone study with a test set, expert ground truth, or MRMC studies.

Therefore, much of the requested information regarding acceptance criteria, specific study design elements (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance), and details on training set ground truth cannot be directly extracted from this document, as it outlines a comparison and testing against existing standards and predicate devices.

However, I can extract information about the types of performance data used to support substantial equivalence, which acts as a proxy for meeting certain "acceptance criteria" related to safety and effectiveness by demonstrating similarity to already cleared devices.

Here's a breakdown of what can be inferred:

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

The document does not present explicit acceptance criteria with numerical targets in the traditional sense, as it relies on demonstrating substantial equivalence to predicate devices and adherence to recognized standards. The "reported device performance" is framed as meeting these standards or being comparable to predicate devices.

Acceptance Criteria (Inferred from testing performed)	Reported Device Performance (as stated in document)
Biocompatibility: Device material is biocompatible.	Made of titanium alloy conforming to ASTM F136; same material as previously cleared Neodent Implant System components (K150367). No new biocompatibility testing performed, as material is commonly used and cleared.
Mechanical Strength: Device demonstrates sufficient strength and fatigue resistance.	Strength demonstrated through fatigue testing according to ISO 14801 and FDA Guidance for Industry. No new fatigue tests performed as the device does not present a new worst case compared to reference device (K153624).
Software Verification & Validation: Software functions correctly and does not pose undue risk.	Considered "moderate" level of concern. Verified and validated with respect to functionality and design using the Sirona validated workflow (same as primary predicate).
Sterilization Efficacy (Manufacturer): Sterilization process achieves appropriate Sterility Assurance Level (SAL).	Validated according to ISO 11135 (Ethylene Oxide) to achieve a SAL of 10⁻⁶.
Sterilization Efficacy (End-user): Recommended end-user sterilization method is effective.	Moist heat (steam) sterilization validated according to ISO 17665-1 and ISO/TR 17665-2 to achieve a SAL of 10⁻⁶.
Substantial Equivalence: Features and performance are comparable to identified predicate devices.	Detailed comparison table (Table 2) provided demonstrating equivalence in indications, dimensions, connections, materials, manufacturing workflow, and sterilization.

2. Sample sized 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 as a separate "test set" for performance evaluation in the typical sense.
- Biocompatibility: No new testing was performed; reliance on prior clearance of the material.
- Mechanical Testing: Not specified for this submission, but it refers to tests presented in K153624 (a reference predicate). For fatigue testing per ISO 14801, a specific number of samples (typically 5, 8, or 10, depending on the method) would be tested. The number isn't provided here.
- Software Verification & Validation: The document states the "Titanium Base for CEREC was verified and validated with respect to its functionality and design using the Sirona validated workflow." This implies testing against the workflow, but specific sample sizes (e.g., number of test cases, scenarios) are not provided.
- Sterilization Validation: Sterilization validation studies typically involve a defined number of biological indicators (BIs) or process challenge devices (PCDs) per run, over multiple runs. Specific numbers are not provided, only the standards used (ISO 11135, ISO 17665-1).
Data Provenance: Not explicitly stated. Given Neodent's location in Brazil (JJGC Indústria e Comércio de Materiais Dentários SA, Curtiba, Parana, BRAZIL), it's reasonable to infer that any original data generation would have been conducted in either Brazil or relevant testing laboratories supporting their operations, or by the manufacturers of the predicate devices. The study type (retrospective/prospective) is not detailed.

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 implant component, not an AI or diagnostic imaging device that requires expert adjudication for ground truth. Its performance is evaluated through material properties, mechanical testing, and software validation.

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

Not applicable, as this is not an AI or diagnostic imaging device for which such adjudication methods would be relevant.

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 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 physical medical device. Software verification was performed, but not as a "standalone algorithm" in the typical sense of AI performance evaluation.

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

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

Material Specifications: Adherence to ASTM F136 for titanium alloy.
Mechanical Performance: Demonstrating strength and fatigue resistance according to ISO 14801.
Sterilization Efficacy: Achieving performance per ISO 11135 and ISO 17665-1 standards.
Software Functionality: Verification and validation against predefined functional requirements within the Sirona validated workflow.
Predicate Device Equivalence: The ultimate "ground truth" for this 510(k) is that the device is as safe and effective as its legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm trained on data sets. The "training set" concept is not relevant here.

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

Not applicable, for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

September 16, 2016

JJGC Indústria e Comércio de Materiais Dentários SA % Jennifer Jackson Senior Manager, Regulatory Affairs & Quality Management Straumann USA, LLC 60-100 Minuteman Road Andover, Massachusetts 01810

Re: K160964

Trade/Device Name: Neodent Implant System - Titanium Bases For Cerec Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 11, 2016 Received: August 18, 2016

Dear Jennifer 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 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

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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 yours,

Michael J. Ryan -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)

K160964

Device Name

Neodent Implant System - Titanium Bases for CEREC

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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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 SAAv. Juscelino Kubitschek de Olivera, 3291Curtiba, Parana, BRAZIL 81270-200Registration No.: 3008261720Owner/Operator No.: 10031702
Contact Person	Jennifer Jackson, MSHead of Quality and Regulatory, Straumann USATelephone (978) 747-2509
Date Prepared	15/Sep/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 – Titanium Bases for CEREC
Primary Predicate	K151324 - Straumann® Variobase™ for CEREC Abutments, InstitutStraumann AG
Reference Predicates	K153624 - Neodent Implant System, JJGC Indústria e Comércio deMateriais Dentários SAK111421 - Sirona Dental CAD/CAM System

Device Description 5.1

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cylindrical shape
hexagonal indexing at the apical end of the Morse taper connection
indexing guide in the cementable portion for coping fitting

Image /page/4/Picture/7 description: The image shows a dental implant abutment. The abutment is made of metal and has a cylindrical shape. The top of the abutment has a hole in it, and the bottom of the abutment has a screw thread. The abutment is used to connect a dental crown to a dental implant.

Figure 1: Image of a Titanium Base for CEREC abutment

The Titanium Base for CEREC is provided sterile by Ethylene Oxide and steam sterilization is recommended after the cementation of the customized superstructure on the Titanium Base for CEREC.

The Titanium Base for CEREC is compatible with the following devices:

Dental implants

All Neodent dental implants having Morse taper implant-to-abutment interface (CM line) cleared under K101945, K123022, K133592, K150182 and K150199.

Raw material blanks

-InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664;
-IPS e.max CAD Abutments Solutions (LiSi₂) by Ivoclar Vivadent AG, L size blanks, cleared under K132209.

Software

Sirona Dental CAD/CAM System, by Sirona Dental Systems GmbH, cleared under K111421.

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No change has been made in the software, its settings or configuration, as well as any modification in the workflow. Sirona inLab software (version 3.65) or Sirona CEREC® Software (version 4.2) are to be used to design the prosthesis structure according to the previous prosthetic planning. Therefore, the customers are required to use the device models (3D models) and the workflow defined and validated by Sirona through K111421, according to the Instruction for Use of Titanium Base for CEREC

Instruments

-Neodent screwdrivers (class I - exempt devices)
Sirona scanbodies (class I exempt devices) ।

Note: The raw material blanks, the scanbodies and the software are not subject of this submission and are not supplied by Neodent. They are identical to the compatible materials used for predicate devices K151324.

5.2 Indications for Use

5.3 Technological Characteristics

Both the subject and the reference devices have the same indication of providing support for prostheses. All devices are pre-manufactured (stock) abutments made of titanium alloy design to be used as a base when fabricating a CAD/CAM customized superstructure and are compatible with the same CAD/CAM System and blocks of raw material. A clinician or dental laboratory equipped with the Sirona Dental CAD/CAM System will design and mill the customized superstructure, which composes the final medical device after the bonding to the Titanium Base for CEREC.

The subject devices differ from the primary predicate devices cleared under K151324 only in the portion of implant connection, which is specific for each manufacturer. The cementable portion is identical and compatible with the Sirona Dental CAD/CAM System and the blocks of raw material.

In the end of this Section a comparison between the features of subject device and its predicate devices is shown in a tabular format. The assessment of the differences is also included.

5.4 Performance data

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The following performance data supports the substantial equivalence determination: Biocompatibility testing

The subject device Titanium Base for CEREC abutment is made of titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). This material is commonly used for endosseous dental implant abutments and is the same material used for Neodent Implant System components previously cleared in K150367. Therefore, no new biocompatibility testing has been performed.

Mechanical testing

The strength of the system is demonstrated through fatigue testing performed 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. The Neodent Titanium Base for CEREC does not present a new worst case when compared to the reference device Neodent Titanium Base cleared under K153624. So, no new fatigue tests have been performed, and the same tests presented in K153624 were used to demonstrate the substantial equivalence.

Software Verification and Validation Testing

The recommended software was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator. Therefore, the subject Titanium Base for CEREC was verified and validated with respect to its functionality and design using the Sirona validated workflow. The recommended CAD/CAM System is the same used for the primary predicate device and the validation performed was based on the validation presented by the manufacturer of the primary predicate device.

Note: Neodent makes no changes to the software, its settings or configuration, as well as no modification in the workflow defined and validated by Sirona per K111421. The Sirona software is recommended because of the compatibility of its existing 3D models with the subject devices.

Sterilization validation

The subject Titanium Base for CEREC abutments are provided sterilized by exposure to ethylene oxide (EO). Sterilization has been validated according to ISO 11135 - Sterilization of health care products - Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices using Annex B - Conservative determination of lethal rate of the sterilization process – Overkill approach.

Following fabrication of the superstructure for the Titanium Base, the assembled (cemented) final abutment must be sterilized before use by moist heat (steam). The recommended sterilization has been validated according to ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices, and ISO/TR 17665-2 Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1.

JJGC Indústria e Comércio de Materiais Dentários S.A.

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Both methods achieve a Sterility Assurance Level (SAL) of 10 °.

Clinical data

No clinical data has been submitted, referenced, or relied upon to demonstrate substantial equivalence.

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Table 2: Comparison between the subject and predicate devices.

	SUBJECT DEVICE	PRIMARY DEVICES	REFERENCE PREDICATE
	Neodent Implant System -Titanium Base for CEREC®	Straumann® Variobase® forCEREC® (K151324)	Neodent Implant System(K153624)	Sirona Dental CAD/CAM System(K111421)	EQUIVALENCE DISCUSSION
Indications forUse	The Titanium Base for CERECis a titanium component thatis placed over NeodentImplants to provide supportfor custom prostheticrestorations, such as copingsor crowns. It is indicated forsingle-tooth screw-retainedrestorations.All digitally designed copingsand/or crowns for use withthe Neodent Titanium Basefor CEREC are to be designedusing Sirona inLab softwareor Sirona CEREC Software andmanufactured using a SironaCEREC or inLab MC X or MC XLmilling unit.	The Straumann® Variobase®for CEREC® are titaniumalloy abutments placed ontoStraumann dental implantsto provide support forcustomized prostheticrestorations. Straumann®Variobase® for CEREC®abutments are indicated forscrew-retained single toothor cement-retained singletooth and bridgerestorations.All digitally designedcopings and/or crowns foruse with the Straumann®Variobase® for CEREC®abutments are to bedesigned using Sirona inLabsoftware(Version 3.65) or SironaCEREC Software (Version4.2) andmanufactured using aSirona CEREC or inLab MC Xor MC XL milling unit.	Titanium Base Abutment is atitanium base placed ontoNeodent dental implants toprovide support forcustomized prostheticrestorations. It is used with acoping and crown, or crownalone, and is indicated forcement-retained single ormulti-unit restorations, orscrew-retained singlerestorations.All digitally designed copingsand/or crowns for use withthe Neodent Titanium BaseAbutment System areintended to be sent toStraumann for manufacture ata validated milling center.	The Sirona Dental CAD/CAM System isintended for use in partially or fullyedentulous mandibles and maxillae insupport of single or multiple-unitcement retained restoration. Thesystem consists of three major parts:TiBase, InCoris mesostructure, andCAD/CAM software. Specifically, theInCoris mesostructure and TiBasecomponents make up a two-pieceabutment which is used in conjunctionwith endosseous dental implants torestore the function and aesthetic inthe oral cavity. The InCorismesostructure may also be used inconjunction with the Camlog Titaniumbase CAD/CAM (types K2244.xxxx)(K083496) in the Camlog ImplantSystem. The CAD/CAM software isintended to design and fabricate theInCoris mesostructure. The InCorismesostructure and TiBase two-pieceabutment is compatible with thefollowing implant systems:Nobel Biocare Replace (K020646)Nobel Biocare Branemark (K022562)Friadent Xive (K013867)Biomet 3i Osseotite (KK980549)Astra Tech Osseospeed (K091239)Zimmer Tapered Screw-Vent (K061410)Straumann SynOcta (K061176)Biomet 3i Certain (K014235)Nobel Biocare Active (K071370)	EquivalentThe basic indication ofproviding support forprostheses is identical. Alldevices are CAD/CAMabutment design to be usedas a base when fabricating acustomized superstructure.The subject devices arecompatible with the sameCAD/CAM System as theprimary predicate device.
	SUBJECT DEVICE	PRIMARY DEVICES	REFERENCE PREDICATE
	Neodent Implant System - Titanium Base for CEREC®	Straumann® Variobase® for CEREC® (K151324)	Neodent Implant System (K153624)	Sirona Dental CAD/CAM System (K111421)	EQUIVALENCE DISCUSSION
Abutment Diameter(s)	4.65 mm	4.5 to 7.0 mm	3.5 and 4.5 mm	Unknown	EquivalentSubject devices diameter is within the range of diameters for the primary predicate devices and does not represent a worst case in terms of performance.
Implant-to-Abutment Connection	Morse taper (CM) interface	RN (Regular Neck),WN (Wide Neck),NC (Narrow CrossFit), andRC (Regular CrossFit)	Morse taper (CM) interface	Unknown	EquivalentThe implant-to-abutment interfaces of Neodent and Straumann devices are not interchangeable but it is identical to the reference predicates of K153624.
Compatibility	Morse taper (CM) implant lines of Neodent Implant System.	Straumann implant lines, as indicated by the implant-to-abutment interfaces.	Morse taper (CM) implant lines of Neodent Implant System.	Unknown	EquivalentThe implant-to-abutment interfaces of Neodent and Straumann devices are not interchangeable but it is identical to the reference predicates of K153624.
Mode of attachment	Screw-retained	Screw-retained or cement retained	Screw-retained or cement retained	Screw-retained	EquivalentSubject device mode of attachment is more restrictive and is within the scope of the primary predicate device's mode of attachment.
	SUBJECT DEVICE	PRIMARY DEVICES	REFERENCE PREDICATE
	Neodent Implant System -Titanium Base for CEREC®	Straumann® Variobase® forCEREC® (K151324)	Neodent Implant System(K153624)	Sirona Dental CAD/CAM System(K111421)	EQUIVALENCE DISCUSSION
RestorationAngulation(s)	Up to 20°	Up to 20°	Up to 30°	Up to 20°	EquivalentThe restoration angulation isidentical among the devicesthat use Sirona DentalCAD/CAM System and onlydiffers for the referencedevice K153624 that iscompatible with othersoftware.
AbutmentHeight(s)	4.7 mm	4.7 mm	4.0 mm	Unknown	EquivalentSubject device height isidentical to that of theprimary predicate device;differs from the referencedevice, which uses otherCADCAM Systems.
Material ofabutment	Titanium-aluminum-vanadium alloy Ti-6Al-4V	Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb)	Titanium-aluminum-vanadium alloy Ti-6Al-4V	Titanium-aluminum-vanadium alloy Ti-6Al-4V	EquivalentThe subject and referencedevices are made of thesame titanium alloy; thetitanium alloy of the primarypredicate device differs, butthe strength of the materialsis demonstrated via dynamicfatigue testing. Also, allmaterials are shown to bebiocompatible.
	SUBJECT DEVICE	PRIMARY DEVICES	REFERENCE PREDICATE
	Neodent Implant System -Titanium Base for CEREC®	Straumann® Variobase® forCEREC® (K151324)	Neodent Implant System(K153624)	Sirona Dental CAD/CAM System(K111421)	EQUIVALENCE DISCUSSION
Material ofsuperstructure	ZirconiaIPS e-max CAD	ZirconiaIPS e-max CADPMMA	ZirconiaIPS e-max CADCo-Cr	Zirconia	EquivalentThe range of materialscleared for use with theprimary predicate andreference devices is withinthe scope of materialsindicated for the subjectdevices.
Patient-specificdesign	CAD/CAM manufacturedsuperstructures	CAD/CAM manufacturedsuperstructures	CAD/CAM manufacturedsuperstructures	CAD/CAM manufacturedsuperstructures	Identical
Manufacturingwork-flow	Sirona Dental CAD/CAMSystem	Sirona Dental CAD/CAMSystem	Straumann validatedworkflow at StraumannMilling Center	Sirona Dental CAD/CAM System	EquivalentThe subject devicemanufacturing work-flow isthe same of the primarypredicate device workflow.
Sterility	Delivered sterile by EOexposure. To be sterilized byuser after superstructurecementation, before placed inpatient mouth.	Delivered non-sterile.; Tobe sterilized by user aftersuperstructurecementation, before placedin patient mouth.	Delivered sterile by EOexposure. To be sterilized byuser after superstructurecementation, before placed inpatient mouth.	Delivered non-sterile; to besterilized by user.	EquivalentAlthough Neodent andpredicate devices are sold tothe customers in differentsterilization condition, allfinal abutments must besterilized by steam before beplaced in patient mouth.
Sterilization byend user	Moist steam sterilization	Moist steam sterilization	Moist steam sterilization	Moist steam sterilization	Identical

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5.5 Conclusions

The documentation submitted in this premarket notification demonstrates that the subject devices have comparable features and performance and, therefore, are substantially equivalent to the identified predicate devices.

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.)