Straumann® BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX Implants can be placed with immediate function on singletooth, bar and bridges applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components.

Straumann® BLX SRAs and Antomic Abutments: Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. Final abutments may be placed into occlusion when the implant is fully osseointegrated. BLX Temporary Abutments have a maximum duration of usage of 180 days.

Device Description

The Straumann BLX Implants are fully tapered implants manufactured utilizing the Roxolid material and are finished with SLActive® surface. The connection is identified as conical fitting with Torx style engaging feature. There are two available prosthetic platforms identified as RB (Regular Base) and WB (Wide Base). The subject devices have a RB platform (a "small top/head") with a Torx-style internal connection, which is identical for all the implant lengths. They are provided sterile by gamma radiation and are available in various sizes.

Straumann® BLX SRAs are manufactured from TAN and are intended to be placed on BLX Straumann dental implants to provide support for permanent screw-retained single or multi-unit restorations. They are provided sterile by gamma radiation and are available in various sizes and angulations.

Straumann® BLX Anatomic Abutments are manufactured from TAN and are intended to be placed on BLX Straumann dental implants to provide support for permanent cement-retained single or multi-unit restorations. They are provided non-sterile and are available in various sizes and angulations. They are delivered with the corresponding basal screw. Anatomic Abutments are provided with pre-defined mucosa margins and with a size that allows for further modification by the customer via hand grinding tools.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Straumann® BLX Line Extension - Implants, SRAs and Anatomic Abutments. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than performing a de novo study to establish new acceptance criteria. Therefore, the information requested in your prompt (Acceptance Criteria and study design for proving it) is not explicitly present in the provided document in the way one might find it for a novel device undergoing clinical trials.

However, based on the performance testing section, we can infer some aspects that act as "acceptance criteria" for demonstrating substantial equivalence to the predicate devices. The study conducted is primarily a series of bench tests and validation studies rather than a clinical trial or a study designed to prove new acceptance criteria.

Here's an attempt to structure the answer based on the provided text, highlighting what is implicitly or explicitly stated about "acceptance" in the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission demonstrating substantial equivalence to predicate devices, explicit "acceptance criteria" as pass/fail thresholds for a novel claim are not presented. Instead, the performance tests aimed to show that the subject device performs equivalently to the predicate devices and meets relevant industry standards. The "performance" column here reflects the outcome of those equivalence demonstrations.

Acceptance Criterion (Inferred from Equivalence Testing)	Reported Device Performance
Sterilization Validation: Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11137-1:2006.	Validated to SAL of 10-6 using the over kill bioburden method in accordance with ISO 11137-2:2013 for BLX implants and SRAs.
Shelf Life: Packaging and materials prevent adverse effects over time.	Shelf life of 5 years demonstrated as packaging is equivalent to predicate/reference devices, and materials are not adversely affected by time.
End-User Sterilization (Anatomic Abutments): Validation according to ISO 17665-1 and ISO 17665-2.	Recommended sterilization method has been validated for BLX Anatomic Abutments.
Pyrogenicity: Meets pyrogen limit specifications (e.g., LAL Endotoxin Analysis with testing limit of 20 EU/device).	Device meets pyrogen limit specifications as determined by LAL Endotoxin Analysis with a testing limit of 20 EU/device (for blood contacting and implanted devices).
Biocompatibility: Equivalent to predicate/reference devices per ISO 10993-1:2009 and FDA Guidance.	Biological assessment shows the subject devices have equivalent body contact, duration, material formulation, and sterilization methods compared to predicate/reference devices. No new testing performed due to equivalence.
Dynamic Fatigue & Static Strength: Equivalent to predicate/reference devices as per FDA guidance for root-form endosseous dental implants.	Dynamic fatigue and static strength tests were performed on both RB and WB platforms (worst-case considerations) and shown to be equivalent to the reference devices.
Insertion Torque: Allows for suitable implant insertion torques.	Insertion torque tests were conducted on worst-case BLX implants (Ø3.75 mm) and demonstrated that the implants and related cutting instruments allow reaching suitable implant insertion torques.

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

Sterilization Validation: The document states that the validation was in accordance with ISO 11137-1:2006 and ISO 11137-2:2013, specifically mentioning the "over kill bioburden method." These standards outline protocols for sample size determination, but the exact sample sizes used for the sterilization validation are not specified in this document.
Bench Testing (Dynamic Fatigue, Static Strength, Insertion Torque): The document mentions that "worst-case considerations" were used for testing various platforms (RB and WB) and implant sizes (e.g., Ø3.75 mm for insertion torque). Specific sample sizes for these bench tests are not provided.
Data Provenance: All data appears to be prospective bench testing and validation studies conducted by or for the manufacturer (Institut Straumann AG / Straumann USA, LLC). No country of origin for the data is specified beyond it being conducted by the applicant's entity.

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

This information is not applicable and not provided in the document. The studies described are engineering and materials science tests (sterilization, biocompatibility, mechanical strength), not studies involving human interpretation or clinical outcomes that would require "experts to establish ground truth." The ground truth for these tests is based on established scientific and engineering principles, international standards (ISO), and FDA guidance documents.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are relevant for studies that involve human interpretation and potential disagreements, such as image reading studies. The described studies are objective engineering tests.

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 and not provided. The device is an endosseous dental implant system, not an AI-powered diagnostic tool or image analysis software. Therefore, an MRMC study or evaluation of AI assistance is irrelevant to this submission.

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

This information is not applicable and not provided. As stated above, this is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the various tests described is derived from:

International Standards: e.g., ISO 11137-1, ISO 11137-2, ISO 17665-1, ISO 17665-2, ISO 10993-1.
FDA Guidance Documents: Such as "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile."
Engineering Principles: For mechanical testing like fatigue, strength, and torque.
Predicate Device Performance: The underlying "ground truth" for a 510(k) submission is that the new device is "substantially equivalent" to predicate devices, meaning it performs as safely and effectively without raising new questions of safety or effectiveness.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" as this is not a machine learning or AI-driven device.

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

This information is not applicable and not provided. There is no "training set" for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 28, 2018

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

Re: K181703

Trade/Device Name: Straumann® BLX Line Extension - Implants, SRAs and Anatomic Abutments Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 27, 2018 Received: November 28, 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 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/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 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 mediation-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) K181703

Device Name

Straumann® BLX Line Extension - Implants, SRAs and Anatomic Abutments

Indications for Use (Describe)

Straumann® BLX Implants

Straumann® BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous patients. BLX Implants can be placed with immediate function on single-tooth, bar and bridge applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components.

Straumann® BLX SRAs and Antomic Abutments

Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. Final abutments may be placed into occlusion when the implant is fully osseointegrated. BLX Temporary Abutments have a maximum duration of usage of 180 days.

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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Straumann® BLX Line Extension - Implants, SRAs, and Anatomic Abutments

510(k) Summary

Submitter's Contact Information

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

60 Minuteman Road

Andover, MA 01810

Phone Number: 1-978-747-2509

Fax Number: 1-978-747-0023

Contact Person: Jennifer M. Jackson, MS

Prepared by: Ana Carolina Martins Vianna Viviana Horhoiu
Date of Submission: December 28, 2018

Name of the Device

Trade Names:	Straumann® BLX Line Extension – Implants, SRAs and AnatomicAbutments
Common Name:	Endosseous Dental Implant
Classification Name:	Endosseous Dental Implant
Regulation Number:	21 CFR 872.364021 CFR 872.3630
Classification:	Class II
Product Codes:	Primary product code DZESecondary product code NHA

Predicate Device(s)

Primary Predicate:

K173961 BLX Implant System .
Reference Devices:
. K071357 – P.004 NC Anatomic Abutments

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Straumann® BLX Line Extension - Implants, SRAs, and Anatomic Abutments

K133421 Straumann Magellan Abutment, Protective Cap, Titanium Copings, . Gold Copings, Basal Screw
. K171757 – Straumann Screw Retained Abutments
K163194 Neodent Implant System GM Line .

Indications for Use

Straumann® BLX Implants

Straumann® BLX SRAs and Anatomic Abutments

Prosthetic components, directly or indirectly connected to the endosseous dental implant, are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. Final abutments may be placed into occlusion when the implant is fully osseointegrated.

BLX Temporary Abutments have a maximum duration of usage of 180 days.

4.1 Device Description

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Straumann® BLX Line Extension - Implants, SRAs, and Anatomic Abutments

The subject devices have a RB platform (a "small top/head") with a Torx-style internal connection, which is identical for all the implant lengths. They are provided sterile by gamma radiation and are available in the following sizes:

Platform	Neck Ø(mm)	Maximum outer Ø(mm)	Length(mm)
RB	3.5	3.75	8
			10
			12
			14
			16
			18

Platform	Ø(mm)	Angulation	Gingivalheights(mm)
RB/WB	4.6	0°	1.5
		0°	2.5
		0°	3.5
			4.5
RB/WB	4.6	17°	2.5
		17°	3.5
		17°	4.5
RB/WB	4.6	30°	2.5
		30°	3.5
		30°	4.5

The angled versions are composed of the body of the abutment with a coupled basal screw whereas in the straight version both parts are machined in one piece.

The SRAs are provided with a transfer piece (Pin).

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Straumann® BLX Line Extension - Implants, SRAs, and Anatomic Abutments

Straumann® BLX Anatomic Abutments are manufactured from TAN and are intended to be placed on BLX Straumann dental implants to provide support for permanent cementretained single or multi-unit restorations. They are provided non-sterile and are available in the following sizes:

Platform	Angulation	Gingival heights (mm)
RB/WB	0°	2.5
		3.5
RB/WB	17°	2.5
		3.5

They are delivered with the corresponding basal screw.

Anatomic Abutments are provided with pre-defined mucosa margins and with a size that allows for further modification by the customer via hand grinding tools.

Technological Characteristics

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

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Straumann® BLX Line Extension – Implants, SRAs, and Anatomic Abutments

	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATEDEVICE
FEATURE		K173961	K163194	EQUIVALENCE DISCUSSION
	Subject Device - BLX Implants	Straumann BLX Implant System	Neodent GM Line
Indicationsfor Use	Straumann® BLX Implants aresuitable for endosteal implantationin the upper and lower jaw and forthe functional and esthetic oralrehabilitation of edentulous andpartially edentulous patients. BLXImplants can be placed withimmediate function on single-tooth,bar and bridge applications whengood primary stability is achievedand with appropriate occlusalloading to restore chewing function.The prosthetic restorations areconnected to the implants throughthe corresponding abutmentcomponents.	Straumann® BLX Implants aresuitable for endosteal implantationin the upper and lower jaw and forthe functional and esthetic oralrehabilitation of edentulous andpartially edentulous patients. BLXImplants can be placed withimmediate function on single-toothapplications when good primarystability is achieved and withappropriate occlusal loading torestore chewing function. Theprosthetic restorations areconnected to the implants throughthe corresponding abutmentcomponents.	The Neodent Implant System isintended to be surgically placedin the bone of the upper orlower jaw to provide support forprosthetic devices such asartificial teeth, to restore chewingfunction. It may be used withsingle-stage or two-stageprocedures, for single or multipleunit restorations, and may beloaded immediately when goodprimary stability is achieved andwith appropriate occlusal loading.	EquivalentAll indications allows for implantplacement in jaw, providingsupport for single-tooth, bar andbridge restorations, and allowingfor immediate loading when goodprimary stability is achieved.
Material	Titanium-13 Zirconium alloy(Roxolid®)	Titanium-13 Zirconium alloy(Roxolid®)	Titanium grade 4	IdenticalIdentical to the primary predicatedevice.
SurfaceTreatment	Hydrophilic SLActive®	Hydrophilic SLActive®	Acqua	IdenticalIdentical to the primary predicatedevice.
Implant toAbutmentConnection	BLX(with conical fitting)	BLX(with conical fitting)	GM interface(with conical fitting)	EquivalentAll connections have conicalfitting.
ImplantDiameter	Ø 3.75 mm	Ø 4.5, 5.5, 6.5 mm	Ø 3.5 to 5.0 mm	EquivalentInto the range of diameters of theprimary predicate and thereference devices.
FEATURE	PROPOSED DEVICESubject Device - BLX Implants	PRIMARY PREDICATE DEVICEK173961Straumann BLX Implant System	REFERENCE PREDICATE DEVICEK163194Neodent GM Line	EQUIVALENCE DISCUSSION
Implant Length	8 to 18 mm	6 to 18 mm	8 to 18 mm	EquivalentInto the range of the predicatedevice and identical to thereference device.
Implant Body	Tapered body	Tapered body	Tapered and cylindrical bodies	EquivalentInto the range of body shapes ofthe primary predicate and thereference devices.
Thread Pitch	1.7 to 2.6	2.0 to 2.8 mm	Not available.	EquivalentThe performance of the differentthread pitches are assessed viainsertion torque test.
Sterilization Method	Irradiation	Irradiation	Irradiation	Identical.

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Straumann® BLX Line Extension - Implants, SRAs, and Anatomic Abutments

Table 1 – Comparison matrix: subject device versus primary and reference predicate devices (BLX Implants)

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Straumann® BLX Line Extension – Implants, SRAs, and Anatomic Abutments

	PROPOSED DEVICE	REFERENCE PREDICATE DEVICE
FEATURE	Subject Device - BLX SRAs	K133421(Straumann MagellanSRAs)	K171757Straumann ScrewRetained Abutments	EQUIVALENCE DISCUSSION
Material	Ti-6Al-7Nb	Ti-6Al-7Nb	Ti-6Al-7Nb	Identical
Implant toAbutmentConnection	BLX(with conical fitting)	CrossFit® (NC and RC)(with conical fitting)	CrossFit® (NC and RC)(with conical fitting)	EquivalentThe subject devices have a conicalimplant-to-abutment fitting as well as thereference devices, nevertheless, eachimplant system has its own engagingfeature in the conical connection.
PlatformDiameter	Ø 4. 6 mm	Ø 3.5 and 4.6 mm	Ø 3.5 and 4.6 mm	EquivalentInto the range of the reference devices'.
GingivalHeights	1.5, 2.5, 3.5 and 4.5 mm	1.0, 2.5 and 4.0 mm	1.0, 2.5, 4.0 and 5.5 mm	EquivalentThe gingival heights of the subjectdevices are into the range of thereference devices'.
Angulation	0, 17 and 30°	0, 17 and 30°	0, 17 and 30°	Identical
SterilizationMethod	Sterile by gamma radiation	Non-sterile/End user sterilized	Sterile by gamma radiation	IdenticalTo one of the reference devices.
Prosthesistype	Screw-retained	Screw-retained	Screw-retained	Identical.

Table 2 – Comparison matrix: subject device versus reference device (SRAs)

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Straumann® BLX Line Extension - Implants, SRAs, and Anatomic Abutments

	PROPOSED DEVICE	REFERENCEPREDICATE DEVICE	EQUIVALENCEDISCUSSION
FEATURE	Subject Device – BLXAnatomic Abutments	K071357(Straumann anatomicabutments)
Material	Ti-6Al-7Nb	Ti	EquivalentBoth materials are titaniumbased. Differences in safetyand performance areaddressed viabiocompatibility and fatigueassessment.
Implant toAbutmentConnection	BLX(with conical fitting)	CrossFit® (NC)(with conical fitting)	EquivalentThe subject devices have aconical implant-to-abutmentfitting as well as the referencedevices, nevertheless, eachimplant system has its ownengaging feature in theconical connection.
GingivalHeights	2.5 and 3.5 mm	2 and 3.5 mm	EquivalentThe gingival heights of thesubject devices are into therange of the referencedevices'.
Total abutmentheight	13.4 to 15.1 mm	10.4 to 12.3 mm	EquivalentAll heights are compatiblewith anatomical conditions.Differences in theperformance are addressedvia fatigue performanceassessment.
Angulation	0 and 17°	0 and 15°	EquivalentThe difference in theangulation is addressed viaperformance assessment.
SterilizationMethod	Non-sterile/End user sterilized	Non-sterile/End user sterilized	Identical.
Prosthesistype	Cement-retained	Cement-retained	Identical.

Table 3 – Comparison matrix: subject device versus reference device (Anatomic Abutments)

Performance Testing

The following performance data support the substantial equivalence determination.

Sterilization Validation and Shelf Life

The BLX implants and SRAs are provided sterile via gamma irradiation at a dose of 25 kilogray (2.5 Mrad) minimum. A sterility assurance level (SAL) of 10-6 has been validated in accordance with ISO 11137-1:2006, Sterilization of health care products –

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Straumann® BLX Line Extension - Implants, SRAs, and Anatomic Abutments

Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, 2006-04-05. The validation method used was the over kill bioburden method in accordance with ISO 11137-2:2013, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose.

The packaging of the BLX sterile devices is equivalent to the packaging of the predicate and reference device and the shelf life is 5 years when considering that the materials are not adversely affected by time.

There are no changes to the sterilization method or processes when compared to the Straumann predicate devices.

The BLX Anatomic Abutments are provided non-sterile and need to be sterilized by moist heat (steam) by the end-user. The recommended sterilization method has been validated according to ISO 17665-1 and ISO 17665-2 applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".

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.

Biocompatibility Testing

Biological assessment has been performed according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and 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" for each of the subject devices.

The subject devices have equivalent nature of body contact, contact duration, material formulation and sterilization methods compared to the primary and reference predicate devices and therefore no new testing has been performed.

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Straumann® BLX Line Extension - Implants, SRAs, and Anatomic Abutments

Bench Testing

Dynamic fatigue, static strength, and insertion torque tests were conducted according to the FDA quidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the Straumann BLX Implant System is equivalent to the predicate and reference devices.

Dynamic fatigue (and static strength) tests were performed to evaluate the fatigue load limits of the proposed Straumann BLX Implants. Based on worst-case considerations, both platforms RB and WB were tested and shown to be equivalent to the reference devices.

Insertion torque tests were conducted on the worst cases defined for BLX implants Ø3.75 mm. With this test, it was demonstrated that the BLX Implants and the related cutting instruments allow reaching suitable implant insertion torques.

Clinical data

No device specific clinical data has been submitted to demonstrate substantial equivalence.

Conclusion

The documentation submitted in this premarket notification demonstrates the Straumann® BLX implants, SRAs and Anatomic Abutments are substantially equivalent to the primary predicate and 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.