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 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 by the corresponding abutment components.

Device Description

The Straumann BLX Ø3.5 mm Implants are fully tapered implants manufactured utilizing the Roxolid material and are finished with SLActive® surface. The BLX connection is identified as conical fitting with Torx style engaging feature (TorcFit connection). There are two available prosthetic platforms identified for BLX Implants: RB (Regular Base) and WB (Wide Base). The subject devices have a RB platform with a TorcFit 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: RB, Maximium outer Ø (mm): 3.5, Length (mm): 8, 10, 12, 14, 16, 18

AI/ML Overview

The provided text describes the Straumann BLX Ø3.5 mm Implants, a medical device for endosseous dental implantation. The information required to describe acceptance criteria and associated studies is extracted below.

1. Table of acceptance criteria and reported device performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting explicit quantifiable acceptance criteria as a standalone device. However, the performance testing section details the types of tests conducted and implicitly states that the results demonstrated equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Sterilization: Sterility Assurance Level (SAL) of 10^-6	Achieved a SAL of 10^-6, validated according to ISO 11137-1:2006 (development, validation, and routine control of sterilization process) and ISO 11137-2:2013 (establishing sterilization dose) using the over kill bioburden method.
Pyrogenicity: Meets pyrogen limit specifications	Met pyrogen limit specifications, with a testing limit of 20 EU/device, determined by LAL Endotoxin Analysis.
Shelf Life:	5 years, due to packaging equivalent to predicate devices and materials not adversely affected by time.
Biocompatibility: Compliant with ISO 10993-1 and FDA Guidance	Biological assessment performed according to ISO 10993-1:2009 and FDA Guidance Document "Use of International Standard ISO 10993-1". No new testing performed as subject devices have equivalent nature of body contact, contact duration, material formulation, and sterilization methods compared to predicate devices. (This implies that the established biocompatibility of the predicate is assumed to apply).
Dynamic Fatigue: Equivalent to predicate devices	Dynamic fatigue tests were conducted in 0.9% NaCl at 37°C and "demonstrated the Straumann BLX Implant System is equivalent to the predicate devices." (No specific numerical acceptance criteria or performance metrics are provided for the subject device or predicate, only a qualitative statement of equivalence.)
Static Strength: Equivalent to predicate devices	Static strength tests were conducted alongside dynamic fatigue tests and "demonstrated the Straumann BLX Implant System is equivalent to the predicate devices." (No specific numerical acceptance criteria or performance metrics are provided for the subject device or predicate, only a qualitative statement of equivalence.)
Insertion Torque: Allows reaching suitable implant insertion torques.	Insertion torque tests were conducted on the "worst cases" for BLX Ø3.5 mm implants and "demonstrated that the BLX Implants and the related cutting instruments allow reaching suitable implant insertion torques." (No specific numerical acceptance criteria or performance metrics are provided, only a qualitative statement of suitability.)

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

Sterilization Validation: The validation method used was the over kill bioburden method. While details on the number of samples for bioburden testing are not specified, it would typically involve a statistically significant number of samples to establish the bioburden and then validate the sterilization process. Data provenance is not specified.
Pyrogenicity: The number of devices tested for LAL Endotoxin Analysis is not specified. Data provenance is not specified.
Bench Testing (Dynamic Fatigue, Static Strength, Insertion Torque): The sample sizes for these tests are not explicitly stated in the document. Data provenance is not specified.
Clinical Data: No device-specific clinical data has been submitted.

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 submission relies on substantial equivalence and bench testing, not clinical studies requiring expert ground truth for a test set.

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

Not applicable, as no clinical test set requiring adjudication by experts was used.

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 a dental implant, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a dental implant, not an algorithm.

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

Not applicable. The equivalence is based on physical and biological testing against established standards and predicates, not clinical ground truth derived from patients.

8. The sample size for the training set:

Not applicable. This device is a physical product, not a software algorithm requiring a training set.

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

Not applicable as there is no training set for this device.

Summary

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December 27, 2019

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

Re: K191256

Trade/Device Name: Straumann BLX Ø3.5 mm Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: November 22, 2019 Received: November 25, 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.

Srinivas Nandkumar, Ph.D. 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)

K191256

Device Name:

Straumann BLX Ø3.5 mm Implants

Indications for Use (Describe)

Straumann® BLX Implants are suitable for endosteal implantation in the upper 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 by the corresponding abutment components.

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)

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FORM FDA 3881 (7/17)

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K191256 – Traditional 510(k)

Straumann BLX Ø3.5 mm Implants

510(k) Summary

5 510(k) Summary

Submitter's Contact Information 5.1

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: +1-978-747-0023
Prepared By &Alternate Contact:	Ana C. M. ViannaRegulatory Affairs and Compliance ManagerInstitut Straumann AGPhone number : +41 61 965 1259
Date of Submission:	December 26, 2019

5.2 Name of the Device

Trade Names:	Straumann BLX Ø3.5 mm Implants
Common Name:	Endosseous dental implant
Classification Name:	Endosseous dental implant
Regulation Number:	§872.3640
Device Classification:	II
Product Code(s):	DZE
Classification Panel:	Dental

5.3 Predicate Device(s)

Primary Predicate:

K181703 Straumann BLX Line Extension Implants, SRAs and Anatomic . Abutments

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K191256 - Traditional 510(k)

Straumann BLX Ø3.5 mm Implants

510(k) Summary

Reference Devices:

. K130222 - Straumann Dental Implant System

Device Description 5.4

Platform	Maximium outer Ø (mm)	Length (mm)
RB	3.5	8
		10
		12
		14
		16
		18

5.5 Intended Use

The Straumann dental implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of patients with missing teeth.

5.6 Indications for Use

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K191256 – Traditional 510(k)

Straumann BLX Ø3.5 mm Implants

510(k) Summary

Technological Characteristics 5.7

FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	PRIMARY PREDICATE DEVICE
K Number	Straumann BLX Ø3.5 mm Implants	K181703	K130222
Indications for Use	Straumann® BLX Implants are suitable forendosteal implantation in the upper andlower jaw and for the functional andesthetic oral rehabilitation of edentulousand partially edentulous patients. BLXImplants can be placed with immediatefunction on single-tooth, bar and bridgeapplications when good primary stability isachieved and with appropriate occlusalloading to restore chewing function. Theprosthetic restorations are connected tothe implants by the correspondingabutment components.	The Straumann® BLX Implants are suitablefor endosteal implantation in the upper andlower jaw and for the functional andesthetic oral rehabilitation of edentulousand partially edentulous patients. BLXImplants can be placed with immediatefunction on single tooth, bar and bridgesapplications when good primary stability isachieved and with appropriate occlusalloading to restore chewing function. Theprosthetic restorations are connected tothe implants through the correspondingabutment components.	Straumann Dental implants are indicatedfor oral endosteal implantation in the upperand lower jaw arches for the functional andaesthetic oral rehabilitation of edentulousand partially dentate patients. Straumann®Dental implants are also indicated forimmediate or early implantation followingextraction or loss of natural teeth. Implantscan be placed with immediate function onsingle-tooth and/or multiple toothapplications when good primary stability isachieved and with appropriate occlusalloading to restore chewing function. Theprosthetic restorations used are singlecrowns, bridges and partial or fulldentures, which are connected to theimplants through the correspondingcomponents (abutments).
Material	Roxolid	Roxolid	Roxolid
Surface Treatment	SLActive®	SLActive®	SLActive®
Implant to AbutmentConnection	BLX TorcFit connection	BLX TorcFit connection	RN, WN, NC, RC
Implant Diameter	3.5 mm	3.75 mm	3.3 to 4.8 mm
Implant Length	8 to 18 mm	8 to 18 mm	6 to 16 mm
Implant Design	BLX fully tapered body	BLX fully tapered body	Cylindrical and partially tapered
Sterilization Method	Irradiation	Irradiation	Irradiation

Table 1 – Comparison of subject device versus primary predicate device (Dental Implants)

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K191256 – Traditional 510(k)

Straumann BLX Ø3.5 mm Implants

510(k) Summary

Performance Testing 5.8

5.8.1 Sterilization Validation and Shelf Life

The BLX implants 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 - 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 subject devices will not be marketed as non-pyrogenic. The method used to make the determination that the device meets pyrogen limit specifications is LAL Endotoxin Analysis. The testing limit is 20 EU/device.

The packaging of the subject devices is equivalent to the packaging of the predicate devices 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.

5.8.2 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 predicate devices and therefore no new testing has been performed.

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K191256 - Traditional 510(k)

Straumann BLX Ø3.5 mm Implants

510(k) Summary

5.8.3 Bench Testing

Dynamic fatigue, static strength, and insertion torque 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 Abutments" and demonstrated the Straumann BLX Implant System is equivalent to the predicate devices.

Dynamic fatigue (and static strength) tests were performed to evaluate the fatigue load limits of the proposed Straumann BLX Implants. The test environment was 0.9% NaCl at 37°. The results show the subject devices are equivalent to the predicate devices. Insertion torque tests were conducted on the worst cases defined for BLX Ø3.5 mm implants.

With this test, it was demonstrated that the BLX Implants and the related cutting instruments allow reaching suitable implant insertion torques.

5.8.4 Clinical data

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

5.9 Conclusion

The documentation submitted in this premarket notification demonstrates the Straumann BLX Ø3.5 mm implants are substantially equivalent to the primary predicate 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.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Indications for Use

Indications for Use (Describe)

CONTINUE ON A SEPARATE PAGE IF NEEDED

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

K191256 – Traditional 510(k)

Straumann BLX Ø3.5 mm Implants

5 510(k) Summary

Submitter's Contact Information 5.1

5.2 Name of the Device

5.3 Predicate Device(s)

K191256 - Traditional 510(k)

Straumann BLX Ø3.5 mm Implants

Device Description 5.4

5.5 Intended Use

5.6 Indications for Use

K191256 – Traditional 510(k)

Straumann BLX Ø3.5 mm Implants

Technological Characteristics 5.7

K191256 – Traditional 510(k)

Straumann BLX Ø3.5 mm Implants

Performance Testing 5.8

5.8.1 Sterilization Validation and Shelf Life

5.8.2 Biocompatibility Testing

K191256 - Traditional 510(k)

Straumann BLX Ø3.5 mm Implants

5.8.3 Bench Testing

5.8.4 Clinical data

5.9 Conclusion

§ 872.3640 Endosseous dental implant.

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