Who is the manufacturer of Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments?

Institut Straumann AG filed the 510(k) submission for Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments (K181703).

What is the FDA product code for Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments

K181703 · Institut Straumann AG · DZE · Dec 28, 2018 · Dental

Device Facts

Record ID	K181703
Device Name	Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments
Applicant	Institut Straumann AG
Product Code	DZE · Dental
Decision Date	Dec 28, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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 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. 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.

Device Story

System consists of fully tapered endosseous dental implants, Screw Retained Abutments (SRAs), and Anatomic Abutments. Implants are manufactured from Roxolid (Titanium-13 Zirconium alloy) with SLActive surface; SRAs and Anatomic Abutments are manufactured from Ti-6Al-7Nb. Implants feature conical connection with Torx-style engaging feature. Used by dental professionals in clinical settings for oral rehabilitation. Implants placed surgically in jawbone; prosthetic components attached to support restorations. SRAs support screw-retained restorations; Anatomic Abutments support cement-retained restorations. Temporary components shape soft tissue during healing. Output is a stable foundation for dental prosthetics, restoring chewing function and esthetics. Benefits include immediate loading capability and biocompatible material integration.

Clinical Evidence

No clinical data submitted. Substantial equivalence supported by bench testing (dynamic fatigue, static strength, insertion torque) and biocompatibility evaluation per ISO 10993-1.

Technological Characteristics

Implants: Roxolid (Ti-13Zr) with SLActive surface. Abutments: Ti-6Al-7Nb. Connection: Conical with Torx-style engaging feature. Sterilization: Gamma radiation (implants/SRAs) or steam (Anatomic Abutments). Dimensions: Implants 8-18mm length, 3.75mm diameter; SRAs/Abutments various heights/angulations. No software/algorithm.

Indications for Use

Indicated for endosteal implantation in upper/lower jaw for functional/esthetic oral rehabilitation of edentulous and partially edentulous patients. Suitable for single-tooth, bar, and bridge applications with immediate function if primary stability is achieved. Temporary components used for soft tissue management (max 180 days, no occlusion); final abutments used after osseointegration.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

BLX Implant System (K173961)

Reference Devices

NC Anatomic Abutments (K071357)
Straumann Magellan Abutment, Protective Cap, Titanium Copings, Gold Copings, Basal Screw (K133421)
Straumann Screw Retained Abutments (K171757)
Neodent Implant System GM Line (K163194)

Related Devices

K233896 — JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus · Jdentalcare Srl · Aug 16, 2024
K181266 — Implantswiss Dental Implant System, Implantswiss Dental Abutment System · Novodent SA · Nov 1, 2018
K163640 — QZA and RS Dental Implant Systems · Trinon Titanium GmbH · May 3, 2017
K200188 — DSI Dental Implant System · Dsi Dental Solutions, Ltd. · Apr 1, 2020
K112440 — AB DENTAL DEVICES IMPLANTS AND ACCESSORIES · A.B. Dental Devices , Ltd. · Apr 18, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 Anatomic Abutments | |----------------------|--------------------------------------------------------------------------| | Common Name: | Endosseous Dental Implant | | Classification Name: | Endosseous Dental Implant | | Regulation Number: | 21 CFR 872.3640 21 CFR 872.3630 | | Classification: | Class II | | Product Codes: | Primary product code DZE Secondary product code NHA | ## Predicate Device(s) Primary Predicate: - K173961 BLX Implant System . Reference Devices: - . K071357 – P.004 NC Anatomic Abutments {4}------------------------------------------------ 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 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 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 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). {5}------------------------------------------------ ## 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 | 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 the following sizes: | Platform | Ø (mm) | Angulation | Gingival heights (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). {6}------------------------------------------------ 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: {7}------------------------------------------------ Straumann® BLX Line Extension – Implants, SRAs, and Anatomic Abutments | | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FEATURE | | K173961 | K163194 | EQUIVALENCE DISCUSSION | | | Subject Device - BLX Implants | Straumann BLX Implant System | Neodent GM Line | | | Indications for Use | 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 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 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 single-tooth 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. | The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. | Equivalent All indications allows for implant placement in jaw, providing support for single-tooth, bar and bridge restorations, and allowing for immediate loading when good primary stability is achieved. | | Material | Titanium-13 Zirconium alloy (Roxolid®) | Titanium-13 Zirconium alloy (Roxolid®) | Titanium grade 4 | Identical Identical to the primary predicate device. | | Surface Treatment | Hydrophilic SLActive® | Hydrophilic SLActive® | Acqua | Identical Identical to the primary predicate device. | | Implant to Abutment Connection | BLX (with conical fitting) | BLX (with conical fitting) | GM interface (with conical fitting) | Equivalent All connections have conical fitting. | | Implant Diameter | Ø 3.75 mm | Ø 4.5, 5.5, 6.5 mm | Ø 3.5 to 5.0 mm | Equivalent Into the range of diameters of the primary predicate and the reference devices. | | FEATURE | PROPOSED DEVICE Subject Device - BLX Implants | PRIMARY PREDICATE DEVICE K173961 Straumann BLX Implant System | REFERENCE PREDICATE DEVICE K163194 Neodent GM Line | EQUIVALENCE DISCUSSION | | Implant Length | 8 to 18 mm | 6 to 18 mm | 8 to 18 mm | Equivalent Into the range of the predicate device and identical to the reference device. | | Implant Body | Tapered body | Tapered body | Tapered and cylindrical bodies | Equivalent Into the range of body shapes of the primary predicate and the reference devices. | | Thread Pitch | 1.7 to 2.6 | 2.0 to 2.8 mm | Not available. | Equivalent The performance of the different thread pitches are assessed via insertion torque test. | | Sterilizatio n Method | Irradiation | Irradiation | Irradiation | Identical. | {8}------------------------------------------------ Straumann® BLX Line Extension - Implants, SRAs, and Anatomic Abutments Table 1 – Comparison matrix: subject device versus primary and reference predicate devices (BLX Implants) {9}------------------------------------------------ Straumann® BLX Line Extension – Implants, SRAs, and Anatomic Abutments | | PROPOSED DEVICE | REFERENCE PREDICATE DEVICE | | | |--------------------------------------|-------------------------------|-------------------------------------------------|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FEATURE | Subject Device - BLX SRAs | K133421 (Straumann Magellan SRAs) | K171757 Straumann Screw Retained Abutments | EQUIVALENCE DISCUSSION | | Material | Ti-6Al-7Nb | Ti-6Al-7Nb | Ti-6Al-7Nb | Identical | | Implant to Abutment Connection | BLX (with conical fitting) | CrossFit® (NC and RC) (with conical fitting) | CrossFit® (NC and RC) (with conical fitting) | Equivalent The subject devices have a conical implant-to-abutment fitting as well as the reference devices, nevertheless, each implant system has its own engaging feature in the conical connection. | | Platform Diameter | Ø 4. 6 mm | Ø 3.5 and 4.6 mm | Ø 3.5 and 4.6 mm | Equivalent Into the range of the reference devices'. | | Gingival Heights | 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 | Equivalent The gingival heights of the subject devices are into the range of the reference devices'. | | Angulation | 0, 17 and 30° | 0, 17 and 30° | 0, 17 and 30° | Identical | | Sterilization Method | Sterile by gamma radiation | Non-sterile/ End user sterilized | Sterile by gamma radiation | Identical To one of the reference devices. | | Prosthesis type | Screw-retained | Screw-retained | Screw-retained | Identical. | Table 2 – Comparison matrix: subject device versus reference device (SRAs) {10}------------------------------------------------ ## Straumann® BLX Line Extension - Implants, SRAs, and Anatomic Abutments | | PROPOSED DEVICE | REFERENCE PREDICATE DEVICE | EQUIVALENCE DISCUSSION | |--------------------------------------|--------------------------------------------|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FEATURE | Subject Device – BLX Anatomic Abutments | K071357 (Straumann anatomic abutments) | | | Material | Ti-6Al-7Nb | Ti | Equivalent Both materials are titanium based. Differences in safety and performance are addressed via biocompatibility and fatigue assessment. | | Implant to Abutment Connection | BLX (with conical fitting) | CrossFit® (NC) (with conical fitting) | Equivalent The subject devices have a conical implant-to-abutment fitting as well as the reference devices, nevertheless, each implant system has its own engaging feature in the conical connection. | | Gingival Heights | 2.5 and 3.5 mm | 2 and 3.5 mm | Equivalent The gingival heights of the subject devices are into the range of the reference devices'. | | Total abutment height | 13.4 to 15.1 mm | 10.4 to 12.3 mm | Equivalent All heights are compatible with anatomical conditions. Differences in the performance are addressed via fatigue performance assessment. | | Angulation | 0 and 17° | 0 and 15° | Equivalent The difference in the angulation is addressed via performance assessment. | | Sterilization Method | Non-sterile/ End user sterilized | Non-sterile/ End user sterilized | Identical. | | Prosthesis type | 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 – {11}------------------------------------------------ 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. {12}------------------------------------------------ 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.