Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

Device Description

The subject devices are part of the BLX implant line, a fully tapered implant manufactured out of Roxolid and having the SLActive or SLA surface. The connection is identified as conical fitting with the Torx style engaging feature. The subject BLX implants have endosteal implant diameters of Ø5.0mm and lengths of 18 mm and diameters of Ø5.5mm and Ø6.5mm and lengths of 14 mm and 16 mm. The subject devices are presented with the WB (Wide Base) prosthetic platform. The internal connection and the prosthetic platform are identical for all subject devices.

AI/ML Overview

This document, a 510(k) summary for the BLX WB dental implants, does not contain the specific information requested about acceptance criteria and the study proving the device meets them in the format of AI/ML device performance. This is because the device described is a traditional medical device (dental implants), not a software as a medical device (SaMD) or an AI/ML-driven diagnostic tool.

Therefore, there is no discussion of:

A table of acceptance criteria and reported device performance related to AI/ML metrics.
Sample size used for test set or data provenance in the context of algorithm evaluation.
Number and qualifications of experts for establishing ground truth for a test set.
Adjudication methods for a test set.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance.
Type of ground truth (expert consensus, pathology, outcomes data in the context of AI/ML).
Sample size for training set or how ground truth was established for a training set.

Instead, the document focuses on:

Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This is shown by comparing indications for use, technological characteristics (materials, surface treatment, connection, dimensions, design), and performance testing.
Performance Bench Testing:
- Dynamic fatigue testing: Conducted according to FDA guidance (Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments). The testing was leveraged from a reference device (K173961), indicating that the new device does not introduce a new worst-case scenario. This implies the acceptance criteria for fatigue are met by demonstrating equivalence to a device that already meets them.
- Insertion tests: Performed for the subject implants, showing "adequate insertion torque in different bone classes" and results "equivalent to the primary predicate device." This implicitly sets acceptance criteria as "adequate" and "equivalent to predicate."
Biocompatibility Testing: Assessed according to ISO 10993-1:2009 and FDA guidance. The conclusion is that "No new issues of biocompatibility are raised for the subject devices," meaning existing biocompatibility standards for similar devices are met.
Sterilization Validation and Packaging:
- Validated to a sterility assurance level (SAL) of 10-6 in accordance with ISO 11137-1:2006 and ISO 11137-2:2013.
- Shelf life: 5 years (identical to predicate).
- Pyrogenicity: Met limit specifications (20 EU/device) via LAL Endotoxin Analysis.

In summary, the "acceptance criteria" for this traditional medical device are largely defined by equivalence to predicate devices and adherence to recognized international standards (ISO) and FDA guidance documents for mechanical performance, biocompatibility, and sterilization. The "study that proves the device meets the acceptance criteria" refers to the bench testing and validation efforts described above, not to clinical trials or AI/ML performance studies.

Summary

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

Re: K212533

Trade/Device Name: BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: December 23, 2021 Received: December 27, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K212533

Device Name:

BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants

Indications for Use (Describe)

Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for multipletooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

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

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

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BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants

510(k) Summary

Submitter's Contact Information

Submitter:	Straumann USA, LLC60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052On the behalf of:Institut Straumann AGPeter Merian-Weg 124052 Basel, Switzerland.
Contact Person:	Jennifer M. Jackson, MSDirector of Regulatory Affairs and QualityPhone Number: +1-978-747-2509Fax Number: +1-978-747-0023
Prepared By:	Corinne ArimateaRegulatory Affairs and Compliance ManagerInstitut Straumann AGPhone Number: +41 61 965 1217
Date of Submission:	January 28, 2022

Name of the Device

Trade Names:	BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) 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

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BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants

Predicate Device(s)

Primary Predicate:

K130222 Straumann Dental Implant Systems .
Reference Device:
K173961 Straumann BLX Implant System .
. K200586 – Straumann TLX Implant System
. K140091 - Xpeed Anyridge Internal Implant Systems
K190662 MRI Compatibility for Existing Straumann Dental Implant Systems .

Device Description

Intended Use

The Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices.

Indications for Use

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BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants

510(k) Summary

Technological Characteristics

The technological characteristics of the subject devices are compared to the primary predicate devices in Table 1. The Ø6.5 x 16 mm subject implant is longer than the predicate and reference devices. As such, the surgical procedure has been updated to provide further guidance for protection of critical anatomical structures:

"The vertical bone availability determines the maximum allowable length of the implant that can be placed. A minimum distance of 2 mm between the apex of the implant and the alveolar nerve should be kept. For easier determination of the vertical bone availability, we recommend the use of an x-ray reference foil with X-ray Reference Sphere (049.076V4)."

The Instructions for Use were also updated to include the following caution/precaution:

"Larger size implants are recommended for the molar region only."

The Indications for Use Statement is similar between the subject and primary predicate devices. The subject submission does not include abutments; therefore, the last sentence of the primary predicate Indications for Use has been omitted from the subject device Indications for Use. The other differences are minor wording changes that do not change the intended meaning of the Indications for Use.

The reference device K190662 is included for reference to the MRI compatibility.

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BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants

510(k) Summary

FEATURE	SUBJECT DEVICE	PRIMARY PREDICATEDEVICE	REFERENCE DEVICE(BLX IMPLANTS)	REFERENCE DEVICE(TLX IMPLANTS)	REFERENCE DEVICE(XPEED ANYRIDGEIMPLANTS)
K Number	K212533	K130222	K173961	K200586	K140091
Indicationsfor Use	Straumann® dentalimplants are indicated forthe functional andesthetic oral rehabilitationof the upper or lower jawof edentulous or partiallyedentulous patients. Theycan be used forimmediate, early or lateimplantation following theextraction or loss ofnatural teeth. Theimplants can be placedwith immediate functionfor single-tooth and/ormultiple-tooth restorationswhen good primarystability is achieved andwith appropriate occlusalloading to restorechewing function.	Straumann® Dentalimplants are indicated fororal endostealimplantation in the upperand lower jaw arches forthe functional andaesthetic oralrehabilitation ofedentulous and partiallydentate patients.Straumann® Dentalimplants are alsoindicated for immediate orearly implantationfollowing extraction orloss of natural teeth.Implants can be placedwith immediate functionon single-tooth and/ormultiple tooth applicationswhen good primarystability is achieved andwith appropriate occlusalloading to restorechewing function. Theprosthetic restorationsused are single crowns,bridges and partial or fulldentures, which areconnected to the implantsthrough thecorrespondingcomponents (abutments).	Straumann® BLXImplants are suitable forendosteal implantation inthe upper and lower jawand for the functional andesthetic oral rehabilitationof edentulous andpartially edentulouspatients. BLX Implantscan be placed withimmediate function onsingle-tooth applicationswhen good primarystability is achieved andwith appropriate occlusalloading to restorechewing function. Theprosthetic restorationsare connected to theimplants through thecorresponding abutmentcomponents.	TLX Implants are suitablefor endosteal implantationin the upper and lowerjaws and for the functionaland esthetic oralrehabilitation ofedentulous and partiallyedentulous patients. TLXImplants can be placedwith immediate functionon single-tooth and multi-unit restorations whengood primary stability isachieved and withappropriate occlusalloading to restore chewingfunction. The prostheticrestorations areconnected to the implantsthrough the correspondingabutment components.	The Xpeed AnyRidgeInternal Implant System isintended to be surgicallyplaced in the maxillary ormandibular molar areasfor the purpose providingprosthetic support fordental restorations(Crown, bridges, andoverdentures) in partiallyor fully edentulousindividuals. It is used torestore a patient'schewing function. Smallerimplants (less than Ø6.0mm) are dedicated forimmediate loading whengood primary stability isachieved and withappropriate occlusalloading. Larger implantsare dedicated for themolar region and areindicated for delayedloading.
FEATURE	SUBJECT DEVICE	PRIMARY PREDICATEDEVICE	REFERENCE DEVICE(BLX IMPLANTS)	REFERENCE DEVICE(TLX IMPLANTS)	REFERENCE DEVICE(XPEED ANYRIDGEIMPLANTS)
K Number	K212533	K130222	K173961	K200586	K140091
Material	Titanium-13 Zirconiumalloy (Roxolid®)	Titanium-13 Zirconiumalloy (Roxolid®)	Titanium-13 Zirconiumalloy (Roxolid®)	Titanium-13 Zirconiumalloy (Roxolid®)	CP Ti Grade 4
SurfaceTreatment	Hydrophilic SLActive®and SLA®	Hydrophilic SLActive®	Hydrophilic SLActive®and SLA®(SLA® introduce byMemo-to-File)	Hydrophilic SLActive®	SLA®
Implant toAbutmentConnection	TorcFit(with conical fitting)	SynOcta and CrossFit	TorcFit(with conical fitting)	TorcFit(with conical fitting)	n/a
ImplantDiameter	Ø5.0, 5.5 and 6.5 mm	Ø3.3, Ø4.1, Ø4.8, andØ4.8 for TL (S, SP, TE)Ø3.3, Ø4.1 and Ø4.8, BL	Ø 4.5, 5.5, 6.5 mm	Ø3.75, 4.0, 4.5, 5.0, 5.5,and 6.5 mm	For normal ridge: 4.0,4.4, 4.9, 5.4 & 5.9 mmFor low ridge: 6.4, 6.9,7.4, 7.9 & 8.4 mm
ImplantLength	Ø5.0 mm:18 mmØ5.5 and 6.5 mm:14 and 16mm	6.0, 8.0, 10.0, 12.0, 14.0& 16.0 mm	Ø4.5 mm:6, 8, 10, 12, 14, 16 and18 mmØ5.5 and 6.5 mm:6, 8, 10, 12 mm	Ø3.75, 4.0, 4.5, 5.0 mm:6, 8, 10, 12, 14, 16 and 18mmØ5.5 and 6.5 mm:6, 8, 10, 12 mm	For normal ridge: 7.7,9.2, 10.7, 12.2, 14.20 &17.2 mmFor low ridge: 7.9, 9.4,10.9, 12.4 & 14.4 mm
ImplantDesign	Tapered body	Cylindrical	Tapered body	Tapered body	n/a
SterilizationMethod	Irradiation	Irradiation	Irradiation	Irradiation	Irradiation

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BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants

510(k) Summary

Table 1 – Comparison of subject device versus primary predicate device

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BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants

Performance Testing

Bench Testing

An assessment regarding 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 do not introduce a new worst case compared to the reference device device. Therefore, dynamic fatigue testing was leveraged from the reference device K173961.

Insertion tests were performed for the subject implants and proved that there is an adequate insertion torque in different bone classes when the implant is inserted according to the surgical procedure. Insertion torque results are equivalent to the primary predicate device.

Biocompatibility Testing

A biological assessment was 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. No new issues of biocompatibility are raised for the subject devices. Therefore, no additional biocompatibility testing was required.

Sterilization Validation and Packaging

The sterilization process for the subject implants 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. 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 subject BLX Implant System is identical to the packaging of the primary predicate devices. 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

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BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants

510(k) Summary

(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 BLX WB implants are substantially equivalent to the primary 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.