The Straumann PURE Ceramic Implant is indicated for the restoration of single-tooth gaps and in edentulous or partially edentulous jaws. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.

Closure and Healing caps are intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Closure and Healing caps should be used only with suitable implant connections. Do not use healing components for longer than 6 months.

The provisional components are intended to serve as a base for temporary crown or bridge restoration out of occlusion for the Straumann® PURE Ceramic Implant System. The Straumann® Temporary Abutment VITA CAD-Temp® for the Straumann® PURE Ceramic Implant is indicated for temporary usage of up to 180 days.

CI RD Straumann PUREbase abutment is a titanium base placed onto Straumann ceramic dental implants to provide support for customized prosthetic restorations and is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

Device Description

The Straumann PURE Ceramic Implant is a dental implant made out of yttrium-stabilized zirconium dioxide (Y-TZP). The Straumann PURE Ceramic Implant is based on features of the Straumann PURE Ceramic implant Monotype. Straumann PURE Ceramic Implants can be placed using the existing instruments using the same osteotomy preparation protocol as for Bone Level implants. The subject implant is a two -piece implant and is available in Ø4.1 mm with lengths of 8, 10, 12, and 14 mm.

The Closure and Healing caps are screws machined as one piece and come in three gingival heights to accommodate individual gingival thickness. The material of the devices is titanium grade 4. The Closure caps are screwed into the implant to protect the inner configuration and shoulder of the implant during the healing phase in cases of submerged (submucosal) healing protocols and do not support a prosthetic restoration. Healing caps are screwed into the implant to protect the inner configuration in cases of transmucosal healing protocols and are placed out of occlusion and do not support a prosthetic restoration.

The Temporary Abutments are used to serve as a temporary crown or bridge restoration for the Straumann PURE Ceramic Implant System.

The CI RD Straumann PUREbase Abutment for Ceramic implant is a premanufactured (stock) abutment (the first piece of the two-piece abutment), sometimes referred to as "Tibase", and is used as a base when fabricating a CAD/CAM customized restoration (the second piece of the two-piece abutment). The assembly of the two-pieces becomes a finished medical device after cementation of the CAD/CAM customized restoration on the PURE base abutment.

AI/ML Overview

The Straumann PURE Ceramic Implant System did not present specific, quantified acceptance criteria with corresponding performance data in the provided text. Instead, the document focuses on demonstrating substantial equivalence to predicate and reference devices through various tests.

However, based on the provided "Performance Data 5.7" section and the comparison tables, we can infer the types of acceptance criteria and the nature of the study that proves the device meets those criteria. The acceptance criteria generally revolve around demonstrating equivalence to legally marketed predicate and reference devices in terms of safety and effectiveness, as per FDA guidelines for 510(k) submissions.

Here's an attempt to structure the information based on the request, interpreting "acceptance criteria" as the performance standards expected for demonstrating substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit numerical acceptance criteria were not stated, this table describes the type of performance evaluated and the outcome in relation to the predicate/reference devices.

Acceptance Criterion (Inferred from regulatory requirements and comparative studies)	Reported Device Performance
Biocompatibility: Device materials are safe for biological contact and do not cause adverse reactions. (In accordance with ISO 10993-1:2009).	The subject device materials are identical to the predicate and reference device materials. Therefore, no new issues regarding biocompatibility were raised.
Sterilization Efficacy (for sterile components): Sterilization process reliably achieves a Sterility Assurance Level (SAL) of 10-6. (Per ISO 11135).	Sterilization validation was performed using the Half Cycle Overkill Approach, demonstrating the process can reliably and consistently sterilize to a minimum SAL of 10-6.
Pyrogenicity: Device does not contain pyrogens above acceptable limits. (Based on FDA Guidance, testing limit of 20 EU/device for blood contacting/implanted devices).	The device meets pyrogen limit specifications as determined by LAL Endotoxin Analysis, with a testing limit of 20 EU/device.
Reprocessing Validation (for non-sterile components to be reprocessed by end-user): Reprocessing methods (e.g., autoclaving) are effective. (Per ISO 17665-1:2006 and FDA guidance).	The sterilization process for the Straumann PURE temporary abutment and CI RD Straumann PUREbase abutments (as recommended in labeling) was validated according to applicable recommendations in FDA guidance and ISO 17665-1:2006.
Mechanical Strength/Fatigue: Device can withstand dynamic loading forces typical of oral function without failure. (Per ISO 14801:2016 and FDA guidance).	Dynamic fatigue tests demonstrated the Straumann PURE Ceramic Implant, Straumann PURE temporary abutments, and CI RD Straumann PUREbase abutments are equivalent to the predicate and reference devices.
Wear on Implant-to-Abutment Connection: Connection surfaces exhibit comparable wear behavior to predicate/reference devices.	Post-fatigue bench tests concluded comparable behavior of the subject device to the reference devices in terms of wear on the implant-to-abutment connection.
Screw Loosening: Risk of screw loosening is comparable to predicate/reference devices.	Post-fatigue bench tests concluded comparable behavior of the subject device to the reference devices in terms of screw loosening. A literature review was also provided to evaluate the risk of screw loosening with ceramic abutments.

2. Sample Size Used for the Test Set and Data Provenance

The document describes bench testing for mechanical performance, biocompatibility, and sterilization. It does not refer to a "test set" in the context of clinical data or data from human subjects.

Sample Size: Not explicitly stated for each test, but typically, mechanical and sterilization validations involve a statistically representative number of units or replicates to demonstrate consistency and meet statistical confidence levels defined in the relevant ISO standards (e.g., ISO 11135, ISO 14801). Biocompatibility is based on material composition equivalency, not a specific sample size.
Data Provenance: The studies are described as bench tests (laboratory studies), biocompatibility assessments based on material equivalency, and sterilization/reprocessing validations. There is no mention of country of origin of data in the context of test subjects, as these are not human studies for this specific assessment. The data is generated from laboratory testing and analytical comparisons.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is typically relevant for studies involving human interpretation (e.g., image analysis by radiologists). For this device, which involves material properties and mechanical performance, the "ground truth" is established by adherence to international standards (ISO) and FDA guidance documents, and the expertise lies in the validation engineers and materials scientists performing and interpreting these tests. There is no mention of "experts" in the sense of clinical adjudicators for a "test set" in the provided text.

4. Adjudication Method for the Test Set

Not applicable as this is not a study involving human interpretation of medical data (e.g., images) requiring adjudication of findings. Performance is evaluated against objective engineering and scientific standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an endosseous dental implant system, not an AI-powered diagnostic or assistive technology.

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

Not applicable. This device is not an algorithm or software. It is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluations (mechanical, sterilization, biocompatibility) is defined by the International Organization for Standardization (ISO) standards and FDA guidance documents to which these tests were conducted.

Biocompatibility: ISO 10993-1:2009.
Sterilization: ISO 11135 and FDA Guidance on "Submission and Review of Sterility Information...".
Reprocessing: ISO 17665-1:2006 and FDA guidance "Reprocessing Medical Devices in Health Care Settings...".
Mechanical Testing (Dynamic Fatigue): ISO 14801:2016 and FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
Wear and Screw Loosening: Bench tests demonstrating comparable behavior to reference devices, supported by a literature review for screw loosening risk.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This device is not an AI/machine learning 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 letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 4, 2019

Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801

Re: K180477

Trade/Device Name: Straumann PURE Ceramic Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: December 3, 2018 Received: December 4, 2018

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. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Andrew I. Steen -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180477

Device Name Straumann PURE Ceramic Implant System

Indications for Use (Describe)

Straumann PURE Ceramic Implant:

Closure and healing caps:

Temporary Abutments:

The provisional components are intended to serve as a base for temporary crown or bridge restoration out of occlusion for the Strauman® PURE Ceramic Implant System. The Straumann® Temporary Abutment VITA CAD-Temp® for the Straumann® PURE Ceramic Implant is indicated for temporary usage of up to 180 days.

CI RD Straumann PUREbase Abutments:

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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K180477 – Straumann® PURE® Ceramic Implant System

510(k) Summary

510(k) Summary 5

Submitter 5.1

Straumann USA, LLC (on behalf of Institut Straumann AG)

60 Minuteman Road

Andover, MA 01810

Phone Number:	(978) 747-2509
---------------	----------------

Fax Number: (978) 747-0023

Contact Person: Jennifer M. Jackson, MS

Date of Submission: January 4, 2019

5.2 Device

Trade Name:	Straumann PURE Ceramic Implant System
Common Name:	Endosseous Dental ImplantEndosseous Dental Implant Abutment
Classification Name:	21 CFR 872.3640
Regulatory Class:	II
Primary Product Code:	DZE
Secondary Product Code:	NHA

Predicate Device 5.3

Primary Predicate:	K171769 - Straumann PURE Ceramic Implants
Reference Devices:	K151328 – PURE Ceramic ImplantsK163043 – Zeramex P6 Dental Implant SystemK061277 - Straumann Computer Aided Restoration Services(CARES) Ceramic CopingK130808 - Straumann Healing Abutments, Healing Caps, andClosure ScrewsK122192 - Straumann Temporary Abutments VITA CAD-Temp

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K180477 – Straumann® PURE® Ceramic Implant System

510(k) Summary

K142890 – Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit K170354 – Straumann Variobase Abutments K170356 – Straumann Variobase Abutments K173379 – Straumann Variobase for Crown AS

5.4 Device Description

The Straumann PURE Ceramic Implant is a dental implant made out of yttriumstabilized zirconium dioxide (Y-TZP). The Straumann PURE Ceramic Implant is based on features of the Straumann PURE Ceramic implant Monotype. Straumann PURE Ceramic Implants can be placed using the existing instruments using the same osteotomy preparation protocol as for Bone Level implants. The subject implant is a two -piece implant and is available in Ø4.1 mm with lengths of 8, 10, 12, and 14 mm.

The Temporary Abutments are used to serve as a temporary crown or bridge restoration for the Straumann PURE Ceramic Implant System.

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K180477 – Straumann® PURE® Ceramic Implant System

510(k) Summary

pieces becomes a finished medical device after cementation of the CAD/CAM customized restoration on the PURE base abutment.

5.5 Indications for Use

The Closure and Healing caps are intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Closure and Healing caps should be used only with suitable implant connections. Do not use healing components for longer than 6 months.

The CI RD Straumann PUREbase Abutment is a titanium base placed onto Straumann ceramic dental implants to provide support for customized prosthetic restorations and is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

5.6 Technological Characteristics

The technological characteristics of the subjects devices are compared to the primary predicate and reference devices in the following tables:

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K180477 – Straumann® PURE® Ceramic Implant System

FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICES
	SubjectStraumann PURE CeramicImplant SystemStraumann PURE CeramicImplants	K171769Straumann PURE CeramicImplants	K151328Straumann PURE CeramicImplants	K163043Zeramex P6 Dental ImplantSystem
Indicationsfor Use	The Straumann PURE CeramicImplant is indicated for therestoration of single-tooth gapsand in edentulous or partiallyedentulous jaws. The prostheticrestorations used are singlecrowns, fixed partial or fulldentures, which are connectedto the implants through thecorresponding components.	The Straumann® PURE CeramicImplant (Monotype) is indicated forrestoration in single tooth gaps andin an edentulous or partiallyedentulous jaw. The prostheticrestorations used are singlecrowns, fixed partial or fulldentures, which are connected tothe implants through thecorresponding components.The Ø3.3 mm reduced diameterimplants are recommended forcentral and lateral incisors only.	The Straumann® PURE CeramicImplant (Monotype) is indicatedfor restoration in single tooth gapsand in an edentulous or partiallyedentulous jaw. The prostheticrestorations used are singlecrowns, fixed partial or fulldentures, which are connected tothe implants through thecorresponding components.The Ø3.3 mm reduced diameterimplants are recommended forcentral and lateral incisors only.The Straumann® PURE CeramicImplant Protective Cap is intendedto protect the Straumann® PURECeramic Implant (Monotype)during the healing phase afterimplant placement for up to 6months.Temporary copings are intendedto serve as a base for temporarycrown or bridge restoration for theStraumann® PURE CeramicImplant (Monotype) for up to 30days.	The Zeramex® P6 DentalImplant System is intended to besurgically placed in the bone ofthe upper and lower jaw toprovide support for prostheticdevices, such as artificial teeth,in order to restore aesthetics andchewing function.The Zeramex® P6 DentalImplant System can be used forsingle or multiple unitrestorations.The Zeramex® P6 implants areintended for delayed loading.The Zeramex® P6 implants arespecially indicated for patientswith metal allergies/ intolerancesand chronic illness due to metalallergies/intolerances.The Zeramex® P6 (Ø3.3mm SN)implant may only be used in theanterior teeth in the lower jawand lateral incisor in the upperjaw.
Material	Y-TZP according to ISO 13356	Y-TZP according to ISO 13356	Y-TZP according to ISO 13356	Aluminum toughened zirconia
SurfaceTreatment	Sand-blasted, large-grit, acidetched (ZLA®)	Sand-blasted, large-grit, acidetched (ZLA®)	Sand-blasted, large-grit, acidetched (ZLA®)	N/A
FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICES
	SubjectStraumann PURE CeramicImplant SystemStraumann PURE CeramicImplants	K171769Straumann PURE CeramicImplants	K151328Straumann PURE CeramicImplants	K163043Zeramex P6 Dental ImplantSystem
Implant toAbutmentConnection	2-piece Y-TZP dental implant	Integral coping superstructure	Integral coping superstructure	2-piece Y-TZP dental implant
Abutmentto ImplantMode ofAttachment	Screw-retained	Integral coping superstructure	Integral coping superstructure	Screw-retained or cement-retained
RestorationtoAbutmentMode ofAttachment	Cement-retained	Cement-retained	Cement-retained	Cement-retained
EndostealDiameter	Ø4.1 mm	Ø3.3 and Ø4.1 mm	Ø3.3 and Ø4.1 mm	Ø3.3, Ø4.1, and Ø4.8 mm
PlatformDiameter	Ø4.8 mm	Ø3.5 and Ø4.8 mm	Ø3.5 and Ø4.8 mm	N/A
ImplantLength	8, 10, 12, and 14 mm	8, 10, 12, and 14 mm	8, 10, 12, and 14 mm	8, 10, and 12 mm
ImplantDesign	Straight cylindrical implant body	Straight cylindrical implant body	Straight cylindrical implant body	N/A
ThreadPitch	0.8 mm	0.8 mm	0.8 mm	N/A
SterilizationMethod	End user receives productsterilized via Ethylene Oxide toan SAL of 10-6	End user receives productsterilized via Ethylene Oxide to anSAL of 10-6	End user receives productsterilized via Ethylene Oxide to anSAL of 10-6	N/A

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K180477 – Straumann® PURE® Ceramic Implant System

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K180477 – Straumann® PURE® Ceramic Implant System

FEATURE	PROPOSEDDEVICE	REFERENCE DEVICES
	SubjectStraumann PURECeramic ImplantSystemCI RD StraumannPUREbaseAbutments	K142890StraumannVariobaseAbutments	K061277Straumann CARESCeramic Coping	K170354StraumannVariobaseAbutments	K170356StraumannVariobaseAbutments	K173379StraumannVariobaseAbutments for AS
Indications forUse	The CI RD StraumannPUREbase Abutment isa titanium base placedonto Straumannceramic dental implantsto provide support forcustomized prostheticrestorations and isindicated for screw-retained single tooth orcement-retained singletooth and bridgerestorations. All digitallydesigned copingsand/or crowns for usewith the Straumann®Variobase Abutmentsystem are intended tobe sent to Straumannfor manufacture at avalidated milling center.	The Straumann®Variobase™ Abutmentis a titanium baseplaced onto Straumanndental implants toprovide support forcustomized prostheticrestorations.Straumann®Variobase™Abutments areindicated for screw-retained single tooth orcement-retained singletooth and bridgerestorations. All digitallydesigned copingsand/or crowns for usewith the Straumann®Variobase™ Abutmentsystem are intended tobe sent to Straumannfor manufacture at avalidated milling center.	Copings are intendedto provide support forprostheticreconstructions such ascrowns or bridges. TheStraumann C.A.R.E.S.Ceramic Coping isindicated for cementedrestorations. Thecoping can be used insingle toothreplacements andmultiple toothrestorations.	The Straumann®Variobase® Abutmentis a titanium baseplaced onto Straumanndental implants toprovide support forcustomized prostheticrestorations.Straumann®Variobase® Abutmentsare indicated for screw-retained single tooth orcement-retained singletooth and bridgerestorations. All digitallydesigned copingsand/or crowns for usewith the Straumann®Variobase® Abutmentsystem are intended tobe sent to Straumannfor manufacture at avalidated milling center.	The Straumann®Variobase® Abutmentis a titanium baseplaced onto Straumanndental implants toprovide support forcustomized prostheticrestorations.Straumann®Variobase® Abutmentsare indicated for screw-retained single tooth orcement-retained singletooth and bridgerestorations. All digitallydesigned copingsand/or crowns for usewith the Straumann®Variobase® Abutmentsystem are intended tobe sent to Straumannfor manufacture at avalidated milling center.	The Straumann®Variobase® for Crown ASis a titanium base placedonto Straumann dentalimplants to provide supportfor customized prostheticrestorations. Straumann®Variobase® for Crown ASare indicated for screwretained single tooth orcement-retained singletooth and bridgerestorations. A temporaryrestoration can be usedprior to the insertion of thefinal components tomaintain, stabilize andform the soft tissue duringthe healing phase.Temporary restorations areindicated to be placed outof occlusion. All digitallydesigned copings and/orcrowns for use with theStraumann Variobase® forCrown AS are intended tobe sent to Straumann formanufacture at a validatedmilling center.
Material	Ti-6Al-7Nb	Ti-6Al-7Nb	Y-TZP	Ti-6Al-7Nb	Ti-6Al-7Nb	Ti-6Al-7Nb
Implant toAbutmentConnection	RD connection witha Y-TZP implantfixture and a Ti-6Al-7Nb Abutment	TiZr or Ti implantfixture and a Ti-6Al-7Nb Abutment	TiZr or Ti implantfixture and a Y-TZPabutment	TiZr or Ti implantfixture and a Ti-6Al-7Nb Abutment	TiZr or Ti implantfixture and a Ti-6Al-7Nb Abutment	TiZr or Ti implantfixture and a Ti-6Al-7Nb Abutment
FEATURE	PROPOSEDDEVICE	REFERENCE DEVICES
	SubjectStraumann PURECeramic ImplantSystemCI RD StraumannPUREbaseAbutments	K142890StraumannVariobaseAbutments	K061277Straumann CARESCeramic Coping	K170354StraumannVariobaseAbutments	K170356StraumannVariobaseAbutments	K173379StraumannVariobaseAbutments for AS
Diameter	Ø3.6 mm	Ø3.8 - Ø7.0 mm	N/A	Ø3.8 - Ø7.0 mm	Ø3.8 - Ø7.0 mm	Ø3.8 - Ø7.0 mm
Overall Height	6.5 – 8.5 mm	5.9 – 8.9 mm	N/A	5.9 – 8.9 mm	5.9 – 8.9 mm	N/A
Coping/ CrownMaterial	Digital Workflow:polycon® ae(temporary)zerion® LT/HT(permanent)zerion® ML/UTML(permanent)IPS e.max CADMO/LT/HT(permanent)n!ce (permanent)	Traditional Workflow:Type 4 Metals (ISO22674)IPS e.max® PressCeramicDigital Workflow:polycon® ae(temporary)zerion® (permanent)IPS e.max® CADCeramic(permanent)coron® (permanent)	N/A	Digital Workflow:n!ce (permanent)	Digital Workflow:zerion® ML/UTML(permanent)	Traditional Workflow:Type 4 Metals (ISO22674)IPS e.max® PressCeramicDigital Workflow:polycon® ae(temporary)zerion® (permanent)IPS e.max® CADCeramic(permanent)coron® (permanent)zerion ML/UTML(permanent)n!ce (permanent)
MaximumAngulation	30°	30°	30°	30°	30°	30°
DesignWorkflow	CAD with CARESVisual v.11	Wax-up or CAD	N/A	Wax-up or CAD	Wax-up or CAD	CAD with CARESVisual v.11
FEATURE	PROPOSEDDEVICE	REFERENCE DEVICES
	SubjectStraumann PURECeramic ImplantSystemCI RD StraumannPUREbaseAbutments	K142890StraumannVariobaseAbutments	K061277Straumann CARESCeramic Coping	K170354StraumannVariobaseAbutments	K170356StraumannVariobaseAbutments	K173379StraumannVariobaseAbutments for AS
ManufacturingWorkflow	Straumann Milling	Traditional casting orpressing orStraumann Milling	N/A	Straumann Milling	Straumann Milling	Traditional casting orpressing orStraumann Milling
SterilizationMethod	Non-sterile - Enduser sterilized viaautoclave	Non-sterile - Enduser sterilized viaautoclave	N/A	Non-sterile - Enduser sterilized viaautoclave	Non-sterile - Enduser sterilized viaautoclave	Non-sterile - Enduser sterilized viaautoclave
Mode ofAttachment	Screw-retained orcement-retained	Screw-retained orcement-retained	N/A	Screw-retained orcement-retained	Screw-retained orcement-retained	Screw-retained orcement-retained

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K180477 – Straumann® PURE® Ceramic Implant System

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K180477 – Straumann® PURE® Ceramic Implant System

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K180477 – Straumann® PURE® Ceramic Implant System

FEATURE	PROPOSED DEVICE	REFERENCE DEVICES
	SubjectStraumann PURE Ceramic ImplantSystemClosure and Healing Caps	K130808Straumann Healing Abutments,Healing Caps, and Closure Screws
Indications forUse	The Closure and Healing caps areintended for use with the StraumannDental Implant System (SDIS) to protectthe inner configuration of the implant andmaintain, stabilize and form the softtissue during the healing process.Closure and Healing caps should be usedonly with suitable implant connections.Do not use healing components forlonger than 6 months.	Closure Screws, healing caps, andhealing abutments, are intended for usewith the Straumann Dental ImplantSystem (SDIS) to protect the innerconfiguration of the implant and maintain,stabilize and form the soft tissue duringthe healing process.Customizable healing abutments made ofPEEK are for use for up to 6 months.
Material	Titanium Grade 4	Titanium Grade 4
Implant to CapConnection	RD with a Y-TZP implant fixture and a TiCap	RN/WN/NNC connections with TiZr or TiImplant fixture and Ti Cap
Implant to CapMode ofAttachment	Screw-retained	Screw-retained
Diameter	Closure Cap: Ø4.8 mmHealing Cap: Ø5.2 mm	Closure and Healing Caps: from Ø3.5 –Ø5.5 mm
Overall Height	Closure Cap: 4.6 mmHealing Cap: 6.2 and 7.2 mm	Closure Cap: 6.2 and 6.8 mmHealing Cap: 8.1 - 11.1 mm
GingivalHeight	Closure Cap: 0.5 mmHealing Cap: 2.0 and 3.0 mm	Closure Cap: 0 and 0.5 mmHealing Cap: 2.0 and 3.0 mm
SterilizationMethod	End user receives product sterilized viaIrradiation to an SAL of 10-6

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K180477 – Straumann® PURE® Ceramic Implant System

510(k) Summary

FEATURE	PROPOSED DEVICE	REFERENCE DEVICES
	SubjectStraumann PURE Ceramic ImplantSystem	K122192
	Temporary Abutments	Straumann Temporary AbutmentsVITA CAD-Temp
Indications forUse	The provisional components are intendedto serve as a base for temporary crown orbridge restoration out of occlusion for theStraumann® PURE Ceramic ImplantSystem. The Straumann® TemporaryAbutment VITA CAD-Temp® for theStraumann® PURE Ceramic Implant isindicated for temporary usage of up to180 days.	Straumann Temporary Abutments VITACAD-Temp are indicated for use withStraumann Bone Level and Tissue Levelimplants for temporary crown and bridgerestorations, and to maintain, stabilizeand shape the soft tissue during thehealing phase for up to six months, andshould be placed out of occlusion.
Material	Ti-6Al-7Nb and polymethyl methacrylate(PMMA)	Ti-6Al-7Nb and polymethyl methacrylate(PMMA)
Implant toAbutmentConnection	RD connection with a Y-TZP implantfixture and a Ti-6Al-7Nb temporaryabutment	RC/RN connection with TiZr or Tiimplants and a Ti-6Al-7Nb temporaryabutment
Diameter	Ø7.0 mm	Ø3.7 – Ø7.0 mm
Overall Height	12.3 mm	12.1 – 16.4 mm
MaximumAngulation	30°	30°
ManufacturingWorkflow	Can be customized using common dentalburs	Can be customized using common dentalburs
SterilizationMethod	Non-sterileEnd user sterilized via autoclave	Non-sterileEnd user sterilized via autoclave

Performance Data 5.7

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The subject device materials are identical to the predicate and reference device materials, therefore, no new issues regarding biocompatibility (according to ISO 10993-1:2009) were raised.

Sterilization

Sterilization validation performed per ISO 11135, Sterilization of healthcare products – Ethylene Oxide - Requirements for development, validation and routine control of a sterilization process for medical devices, using the Half Cycle Overkill Approach. The

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K180477 – Straumann® PURE® Ceramic Implant System

510(k) Summary

validation demonstrates that the sterilization process and equipment is capable of reliably and consistently sterilizing the subject device to a minimum Sterility Assurance Level (SAL) of 10-6.

Pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016." The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device.

The sterilization process for the Straumann PURE temporary abutment and CL RD Straumann PUREbase abutments as recommended in the labeling was validated according to applicable recommnedations inf the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015" and ISO 17665-1:2006 "Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices".

Mechanical Testing

Dynamic fatigue tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and ISO 14801:2016 and demonstrated the Straumann PURE Ceramic Implant, Straumann PURE temporary abutments, and CI RD Straumann PUREbase abutments are equivalent to the predicate and reference devices.

Two additional bench tests were conducted after fatigue testing: Implant-to-abutment connection comparison to evaluate wear of the surfaces of the implant body, abutment and fixation screw and screw loosening comparison. Both data produced concluded of comparable behavior of the subject device to the reference devices in terms of wear on the implant-to-abutment connection and screw loosening.

A literature review was provided to evaluate the risk of screw loosening with ceramic abutments.

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K180477 – Straumann® PURE® Ceramic Implant System

510(k) Summary

Conclusion 5.8

Based upon the assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate and/or reference devices.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.