The Straumann® Retentive System (to which PUREloc belongs) is designed for the use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. The Straumann® Retentive System consists of abutments which are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths and platforms. They are available in different sizes and angles to fit individual patient needs. Straumann® PUREloc abutments are used exclusively on the Straumann PURE Ceramic Implants, are available in 6 heights (1 mm, 2 mm, 3 mm, 4 mm, 5 mm, and 6 mm) and made of Yttrium-stabilized zirconia ceramic (ISO 13356 - Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)). The Straumann® PUREloc abutments are non-engaging and the implant-to-abutment connection is provided for by the basal screw. The basal screw is manufactured from Titanium Grade 4 and is identical to the basal screw cleared under K180477.

AI/ML Overview

This is a 510(k) premarket notification for the Straumann® PUREloc abutments. It describes the device, its intended use, and compares its technological characteristics to predicate and reference devices. However, this document does not contain acceptance criteria for an AI/ML device or a study demonstrating the device meets such criteria.

The information provided in this document pertains to traditional medical device clearance, focusing on:

Substantial Equivalence: Comparing the proposed device to legally marketed predicate devices.
Performance Testing: Bench testing (dynamic fatigue, snapping force, dynamic force), sterilization validation, and biocompatibility evaluations.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, ground truth details, MRMC study, or standalone algorithm performance) related to an AI/ML device from this document. The document describes criteria for dental implant abutments, not an AI/ML system.

Summary

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October 28, 2019

Institut Straumann AG % Jennifer Jackson Director Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K192029

Trade/Device Name: Straumann® PUREloc abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 29, 2019 Received: July 30, 2019

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

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K192029

Device Name:

Straumann® PUREloc abutments

Indications for Use (Describe)

The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann implants.

Type of Use (Select one or both, as applicable) 区Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED

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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (7/17)

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Straumann® PUREloc Abutments

5 510(k) Summary

5.1 Submitter's Contact Information

Submitter:	Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052
Contact Person:	Jennifer M. Jackson, MSDirector of Regulatory Affairs and QualityPhone Number: +1-978-747-2509Fax Number: +1-978-747-0023email: jennifer.jackson@straumann.com
Prepared By &Alternate Contact:	Giulia OranRegulatory Affairs and Compliance ManagerInstitut Straumann AGPhone number : +41 61 965 16 17
Date of Submission:	October 28, 2019

5.2 Name of the Device

Trade Names:	Straumann® PUREloc abutments
Common Name:	Endosseous dental implant abutment
Classification Name:	Endosseous dental implant abutment
Regulation Number:	21 CFR 872.3630
Device Classification :	II
Product Code(s):	NHA
Classification Panel:	Dental
Proprietary Name:	Straumann® PUREloc Abutments

Predicate Device(s) 5.3

Primary Predicate:

. K190040 – Straumann BLX Line Extension – New Abutments

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Straumann® PUREloc Abutments

Reference Devices:

. K180477 – Straumann PURE Ceramic Implant
. K190662 – MRI compatibility for existing Straumann dental implant systems

5.4 Device Description

5.5 Intended Use

Prosthetic components connected to the implant or abutment, are intended for use as an aid in prosthetic rehabilitation.

5.6 Indications for Use

The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann implants.

5.7 Technological Characteristics

The technological characteristics of the subject devices are compared to the primary predicate and reference device in the following table:

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Straumann® PUREloc Abutments

FEATURE	PROPOSED DEVICE	PRIMARY PREDICATEDEVICE	REFERENCE PREDICATEDEVICE	REFERENCE PREDICATEDEVICE
K Number	K192029	K190040	K180477	K190662
Indications forUse	The Straumann® RetentiveSystem is indicated for theattachment of full or partialdentures on Straumann dentalimplants.	Straumann BLX HealingAbutments for Bars and BridgesStraumann Healing abutments areindicated to be placed in thepatient's mouth at the end of theimplant placement to protect theinner configuration of the implantand to form, maintain and stabilizethe soft tissue during the healingprocess.Healing abutments should be usedonly with suitable implantconnections.Healing components have amaximum duration of usage of 6months.Straumann BLX TemporaryAbutments for Bar and BridgesProsthetic components directly orindirectly connected to theendosseous dental implant areintended for use as an aid inprosthetic rehabilitations.Temporary components can be usedprior to the insertion of the finalcomponents to maintain, stabilizeand shape the soft tissue during thehealing phase; they may not beplaced into occlusion. Finalabutments may be placed intoocclusion when the implant is fullyosseointegrated.BLX Temporary Abutments have amaximum duration of usage of 180days.Straumann BLX VariobaseAbutments for Bar and BridgesStraumann® Variobase™ prostheticcomponents directly or indirectlyconnected to the endosseous dental	Straumann PURE CeramicImplant:The Straumann PURE CeramicImplant is indicated for therestoration of single-toothgaps and in edentulous or partiallyedentulous jaws. The prostheticrestorations used are single crowns,fixed partial or full dentures, whichare connected to the implantsthrough the correspondingcomponents.Closure and healing caps:Closure and Healing caps areintended for use with the StraumannDental ImplantSystem (SDIS) to protect the innerconfiguration of the implant andmaintain, stabilize and form the softtissue during the healing process.Closure and Healing caps should beused only with suitable implantconnections. Do not use healingcomponents for longer than 6months.Temporary Abutments:The provisional components areintended to serve as a base fortemporary crown or bridgerestoration out of occlusion for theStraumann® PURE Ceramic ImplantSystem. The Straumann® TemporaryAbutment VITA CAD-Temp® for theStraumann® PURE Ceramic Implantis indicated for temporary usage ofup to 180 days.ci RD Straumann PUREbaseAbutments:ci RD Straumann PUREbaseabutment is a titanium base placed	n/a
FEATURE	PROPOSED DEVICE	PRIMARY PREDICATEDEVICE	REFERENCE PREDICATEDEVICE	REFERENCE PREDICATEDEVICE
K Number	K192029	K190040	K180477	K190662
		implant are intended for use as anaid in prosthetic rehabilitations. Theprosthetic restoration (bridge oroverdenture) can be cemented onthe Straumann® VariobaseTMprosthetic components. A temporaryrestoration can be used prior to theinsertion of the final components tomaintain, stabilize, and form the softtissue during the healing phase.They may not be placed intoocclusion. Final abutments andrestorations may be placed intoocclusion when the implant is fullyosseointegrated.Straumann BLX VariobaseAbutments ASThe Straumann Variobase for CrownAS is a titanium base placed ontoStraumann dental implants toprovide support for customizedprosthetic restorations. StraumannVariobase for Crown AS areindicated for screw retained singletooth or cement-retained single toothand bridge restorations. Atemporary restoration can be usedprior to the insertion of the finalcomponents to maintain, stabilizeand form the soft tissue during thehealing phase. Temporaryrestorations are indicated to beplaced out of occlusion. All digitallydesigned copings and/or crowns foruse with the Straumann Variobasefor Crown AS are intended to besent to Straumann for manufactureat a validated milling center.Straumann BLX NovalocAbutments	onto Straumann ceramic dentalimplants to provide support forcustomized prosthetic restorationsand is indicated for screw-retainedsingle tooth or cement-retainedsingle tooth and bridge restorations.All digitally designed copings and/orcrowns for use with the Straumann®Variobase Abutment system areintended to be sent to Straumann formanufacture at a validated millingcenter.
FEATURE	PROPOSED DEVICE	PRIMARY PREDICATEDEVICE	REFERENCE PREDICATEDEVICE	REFERENCE PREDICATEDEVICE
K Number	K192029	K190040	K180477	K190662
		The Straumann® Retentive Systemis indicated for the attachment of fullor partial dentures on Straumanndental implants.Straumann BLX CARESAbutmentsThe Straumann CARES Abutmentsare indicated for single toothreplacement and multiple toothrestorations. The prostheticrestoration can be cemented ordirectly veneered/screw-retained.
Material	Y-TZP according to ISO 13356	Ti-6Al-4V	Y-TZP according to ISO 13356	n/a
SurfaceTreatment	none	Partially anodized / TiN coated	Sand-blasted, large-grit, acidetched (ZLA®)	n/a
Implant toAbutmentConnection	Screw-retained (via CI BasalScrew)	TorcFit connection	Screw-retained (via CI BasalScrew)	n/a
Diameter	4.8 mm	4.5 mm	4.1 mm (endosteal Ø)4.8 mm (platform Ø)	n/a
Gingival height	1, 2, 3, 4, 5, 6 mm	1.5 to 6.5 mm	n/a	n/a
Abutment-to-restorationconnection	Snap on feature	Snap on feature	n/a	n/a
Type ofrecommendedrestoration	Multi-unit	Multi-unit	n/a	n/a
AbutmentAngulation	straight	0 and 15°	n/a	n/a
SterilizationMethod	Non-sterile/End user sterilized	Non-sterile/End user sterilized	Ethylene Oxide	n/a
FEATURE	PROPOSED DEVICE	PRIMARY PREDICATEDEVICE	REFERENCE PREDICATEDEVICE	REFERENCE PREDICATEDEVICE
K Number	K192029	K190040	K180477	K190662
MRICompatibility	MRI conditional	Labeling does not contain MRISafety Information	Labeling does not contain MRISafety Information	MRI conditional

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Straumann® PUREloc Abutments

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Straumann® PUREloc Abutments

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Straumann® PUREloc Abutments

Table 1 – Comparison of subject device versus primary predicate device and reference predicate device

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Straumann® PUREloc Abutments

The primary predicate (K190040) is included for reference to the Straumann BLX Novaloc Abutments. The indications for use for the primary predicate contains reference to many different types of abutments. The intended use and indications for use of the subject device are identical to the Straumann BLX Novaloc Abutments. Dimensionally, the platform diameter is slightly smaller for the subject device to accommodate the implant diameter of the compatible implants. The material of the subject device is identical to the implants of the reference device (K180477) and the screw used to secure the abutment to the implant is identical to the basal screw cleared under K180477. The reference device (K190662) is included in support of considerations for MRI compatibility.

5.8 Performance Testing

5.8.1 Sterilization

The sterilization process for the PUREloc abutments as recommended in the labeling was validated according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".

5.8.2 Biocompatibility

The subject device materials were evaluated for biocompatibility according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and the biocompatibility evaluation flow chart according to the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016".

Although the subject devices materials are identical to the primary predicate and reference devices, cytotoxicity and chemical characterization tests were performed due to differences in geometry, manufacturing processes, and sterilization processes to confirm biocompatibility. These tests were conducted according to ISO 10993-5, 10993-12, and 10993-18 and confirmed the subject devices are biocompatible.

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Straumann® PUREloc Abutments

Bench testing 5.8.3

Dynamic fatigue was 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 Abutments", furthermore snapping force, and dynamic force tests were performed and demonstrated that the PUREloc abutments are identical to primary predicate (K190040) in terms of performance.

5.9 Conclusion

The documentation submitted in this premarket notification demonstrates the PUREloc abutments are substantially equivalent to the primary predicate and reference 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.)

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

CONTINUE ON A SEPARATE PAGE IF NEEDED

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *

Straumann® PUREloc Abutments

5 510(k) Summary

5.1 Submitter's Contact Information

5.2 Name of the Device

Predicate Device(s) 5.3

Primary Predicate:

Straumann® PUREloc Abutments

Reference Devices:

5.4 Device Description

5.5 Intended Use

5.6 Indications for Use

5.7 Technological Characteristics

Straumann® PUREloc Abutments

Straumann® PUREloc Abutments

Straumann® PUREloc Abutments

Straumann® PUREloc Abutments

Straumann® PUREloc Abutments

5.8 Performance Testing

5.8.1 Sterilization

5.8.2 Biocompatibility

Straumann® PUREloc Abutments

Bench testing 5.8.3

5.9 Conclusion

§ 872.3630 Endosseous dental implant abutment.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!