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 placed with immediate function on single-tooth and multi-unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are connected to the implants through the corresponding abutment components.

Device Description

The BLX Implants are fully tapered implants manufactured utilizing the Roxolid material and finished with the SLA or SLActive surface. The connection is identified as conical fitting with the Torx style engaging feature. The subject BLX implants have endosteal implant diameters of Ø3.75 and Ø4.0 mm with a length of 6 mm and are presented with one prosthetic platform: RB (Regular Base). The internal connection and the prosthetic platform are identical for all subject devices.

AI/ML Overview

This is a 510(k) summary for a dental implant system, which primarily relies on demonstrating substantial equivalence to a predicate device rather than presenting comprehensive clinical study performance against specific acceptance criteria. Therefore, the requested information (acceptance criteria, specific study details like sample size, ground truth methodology, expert qualifications, effect size with AI assistance, MRMC study, and training set information) is not typically found in this type of submission.

The document describes bench testing to demonstrate equivalence, not clinical performance with acceptance criteria in the way one might see for an AI/ML medical device.

However, I can extract information related to the performance testing described:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Dynamic Fatigue Testing	No failure after 2 million cycles in saline (2 Hz, 37°C)	"demonstrated the subject BLX Implants System is equivalent to the predicate and reference devices."
Insertion Torque	Adequate insertion torque in different bone classes	"could be proven that there is an adequate insertion torque in different bone classes"
Biocompatibility	Meets ISO 10993-1:2009 and FDA Guidance	"no new issues regarding biocompatibility were raised" as materials are identical to predicate.
Sterility Assurance Level (SAL)	10⁻⁶	Validated to SAL of 10⁻⁶
Pyrogenicity	Testing limit of 20 EU/device	Meets pyrogen limit specifications via LAL Endotoxin Analysis
Shelf Life	5 years sterility	5 years for devices provided sterile

2. Sample Size and Data Provenance:

Bench Testing (Dynamic Fatigue, Insertion Tests): The document does not specify exact sample sizes for these tests. The nature of these tests (comparing against established predicates) generally involves a representative number of units to ensure consistency and meet engineering standards, but it's not a clinical trial with human subjects.
Data Provenance: Not applicable in the context of clinical study data with geographic origin. The data is generated from laboratory bench tests.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. These are bench tests for mechanical and material properties, not clinical studies requiring expert consensus for ground truth establishment.

4. Adjudication Method for the Test Set:

Not applicable. This relates to clinical data review, not bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This is not a study involving human readers or AI assistance. It's a submission for an endosseous dental implant based on substantial equivalence to existing devices, primarily supported by bench testing.

6. Standalone (Algorithm Only) Performance:

No. This device is a physical medical implant, not an algorithm or AI system.

7. Type of Ground Truth Used:

For mechanical/material properties: The "ground truth" is defined by established engineering and biological standards (e.g., ISO for fatigue, ISO for biocompatibility, FDA guidance for pyrogenicity and sterility).
For substantial equivalence claim: Comparison against the characteristics and performance of legally marketed predicate devices.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

In summary: This 510(k) submission demonstrates substantial equivalence for a dental implant system primarily through non-clinical bench testing rather than large-scale clinical studies with human subjects or AI performance evaluations. The "acceptance criteria" listed are engineering and biological performance targets derived from recognized standards and comparison to predicate devices, not diagnostic accuracy metrics.

Summary

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

Re: K210855

Trade/Device Name: Straumann BLX Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: March 22, 2021 Received: March 23, 2021

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.

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT 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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Indications for Use

510(k) Number (if known)

K210855

Device Name

Straumann BLX Implant System

Indications for Use (Describe)

Straumann BLX Implants are suitable for endosted implantation in the upper and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX implants can placed with immediate function on single-tooth and multi-unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are connected to the implants through the corresponding abutment components.

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 Implant System

510(k) Summary

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
	On the behalf of:Institut Straumann AGPeter Merian weg 124052 Basel, Switzerland
Contact Person:	Jennifer M. Jackson, MSDirector of Regulatory AffairsPhone Number: +1-978-747-2509Fax Number: +1-978-747-0023
Prepared By:	Viviana HorhoiuRegulatory Affairs and Compliance ManagerInstitut Straumann AGPhone number: +41 61 965 1260
Date of Submission:	June 21, 2021

Name of the Device

Trade Names:	Straumann® BLX Implant System
Common Name:	Endosseous dental implant
Classification Name:	Endosseous dental implant
Regulation Number:	§872.3640
Device Classification:	II
Product Code(s):	DZE

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Straumann® BLX Implant System

510(k) Summary

Predicate Device(s)

Primary Predicate:

. K181703 – Straumann BLX Line Extension – Implants, SRAs, and Anatomic Abutments (Institut Straumann AG)
Reference Devices:
. K200586 – Straumann TLX Implant System (Institut Straumann AG)
K150938 Straumann Dental Implant System Roxolid SLA Implants (Institut . Straumann AG)

Device Description

. RB (Regular Base)
The internal connection and the prosthetic platform are identical for all subject devices.

Indications for Use

Technological Characteristics

The technological characteristics of the subject devices are compared to the primary predicate and reference devices in Table 1.

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Straumann® BLX Implant System

510(k) Summary

Feature	Proposed Device	Primary Predicate Device	Primary Predicate Device	Reference Device
	SubjectStraumann BLX ImplantSystem	K181703Straumann BLX LineExtension - Implants, SRAs,and Anatomic Abutments	K200586Straumann TLX ImplantSystem	K150938Straumann Dental ImplantSystem - Roxolid SLA
Indications forUse	Straumann BLX Implants aresuitable for endostealimplantation in the upper andlower jaw and for the functionaland esthetic oral rehabilitation ofedentulous and partiallyedentulous patients. BLXimplants can placed withimmediate function on single-tooth and multi-unit restorationswhen good primary stability isachieved and with appropriateocclusal loading, to restorechewing function. The prostheticrestorations used are connectedto the implants through thecorresponding abutmentcomponents.	Straumann® BLX Implants aresuitable for endostealimplantation in the upper andlower jaw and for the functionaland esthetic oral rehabilitation ofedentulous and partiallyedentulous patients. BLXImplants can be placed withimmediate function on single-tooth, bar and bridgeapplications when good primarystability is achieved and withappropriate occlusal loading torestore chewing function. Theprosthetic restorations areconnected to the implantsthrough the correspondingabutment components.	Straumann TLX Implants aresuitable for endostealimplantation in the upper andlower jaws and for the functionaland esthetic oral rehabilitation ofedentulous and partiallyedentulous patients. TLXImplants can be placed withimmediate function on single-tooth and multi-unit restorationswhen good primary stability isachieved and with appropriateocclusal loading to restorechewing function. The prostheticrestorations are connected tothe implants through thecorresponding abutmentcomponents.	Straumann® dental implants areindicated for oral endostealimplantation in the upper andlower jaw and for the functionaland esthetic oral rehabilitation ofedentulous and partially dentatepatients. Straumann dentalimplants can also be used forimmediate or early implantationfollowing extraction or loss ofnatural teeth. Implants can beplaced with immediate functionon single-tooth and/or multipletooth applications when goodprimary stability is achieved andwith appropriate occlusalloading, to restore chewingfunction. The prostheticrestorations used are singlecrowns, bridges and partial orfull dentures, which areconnected to the implants by thecorresponding elements(abutments).
Material	Titanium-13 Zirconium alloy(Roxolid®)	Titanium-13 Zirconium alloy(Roxolid®)	Titanium-13 Zirconium alloy(Roxolid®)	Titanium-13 Zirconium alloy(Roxolid®)
SurfaceTreatment	Hydrophilic SLActive® and SLA®	Hydrophilic SLActive®	Hydrophilic SLActive®	SLA®
Implant toAbutmentConnection	TorcFit(with conical fitting)	TorcFit(with conical fitting)	TorcFit(with conical fitting)	CrossFit
ImplantDiameter	Ø3.75 and 4.0 mm	Ø3.75 mm	Ø3.75, 4.0, 4.5, 5.0, 5.5, and 6.5mm	Ø 3.3, 4.1, and 4.8 mm
Feature	Proposed Device	Primary Predicate Device	Primary Predicate Device	Reference Device
	SubjectStraumann BLX ImplantSystem	K181703Straumann BLX LineExtension - Implants, SRAs,and Anatomic Abutments	K200586Straumann TLX ImplantSystem	K150938Straumann Dental ImplantSystem - Roxolid SLA
Implant Length	6 mm	8, 10, 12, 14, 16, and 18 mm	Ø3.75, 4.0, 4.5, 5.0 mm:6, 8, 10, 12, 14, 16 and 18 mmØ5.5 and 6.5 mm:6, 8, 10, 12 mm	6, 8, 10, 12, 14 and 16 mm
Implant Design	Tapered body	Tapered body	Tapered body	Parallel and tapered body
Prostheticplatforms	RB	RB	NT, RT, and WT	N/A
SterilizationMethod	Irradiation	Irradiation	Irradiation	Irradiation
MR Labeling	MR Conditional	N/A	MR Conditional	N/A

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Straumann® BLX Implant System

510(k) Summary

Table 1 – Comparison of subject device versus predicate devices – BLX Implant System

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Straumann® BLX Implant System

510(k) Summary

Performance Testing

Bench Testing

Dynamic fatigue testing 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" and demonstrated the subject BLX Implants System is equivalent to the predicate and reference devices. The test was conducted in saline (2 Hz and 37°C) at 2 million cycles covering permanent restoration of the implant without failure.

Insertion tests were performed for the subject devices and it could be proven that there is an adequate insertion torque in different bone classes when the implant is inserted according to the surgical procedure.

Surface area comparison and pull-out testing were leveraged from K200586 as the endosseous surface area of the subject implants is identical to the referenced implants from K200586.

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 device materials are identical to the predicate and reference device materials, therefore, no new issues regarding biocompatibility were raised.

Sterilization Validation and Packaqing

The sterilization process for the subject BLX Implant System as recommended in the labeling was validated to a sterility assurance level (SAL) of 10-6 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-

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Straumann® BLX Implant System

510(k) Summary

2:2013, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose. The packaging of the subject BLX Implant System is equivalent to the packaging of the predicate and reference device. The shelf life for devices provided sterile is 5 years. The devices will not be marketed as non-pyrogenic. 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.

Conclusion

The documentation submitted in this premarket notification demonstrates the subject Straumann BLX Implant System is 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.