Straumann BLX Implant System

K173961 · Institut Straumann AG · DZE · Jun 5, 2018 · Dental

Device Facts

Record IDK173961
Device NameStraumann BLX Implant System
ApplicantInstitut Straumann AG
Product CodeDZE · Dental
Decision DateJun 5, 2018
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

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 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® Closure Caps and Healing Abutments are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and to shape, maintain and stabilize the soft tissue during the healing process. Closure caps and healing abutments should be used only with suitable implant connections. Straumann Closure Caps and Healing Abutments have a maximum duration of usage of 6 months. 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. Straumann® Variobase® prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (crowns) can be cemented onto the Straumann® Variobase® prosthetic components. A temporary restoration can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase; they must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

Device Story

Straumann BLX Implant System consists of fully tapered endosseous dental implants, closure caps, healing abutments, temporary abutments, and Variobase abutments. Implants are placed surgically into the jawbone to support prosthetic restorations. System utilizes a conical implant-to-abutment connection with Torx-style engaging feature. Variobase components support a digital workflow where copings/crowns are designed via CAD software (e.g., Straumann CARES Visual, Dental Wings, 3Shape) and manufactured at a validated milling center. Clinicians use the system to restore chewing function and esthetics. Implants are available in various diameters and lengths. Components are used in clinical settings by dental professionals. System benefits include immediate function capability and soft tissue management during healing.

Clinical Evidence

No clinical data submitted. Substantial equivalence supported by bench testing including dynamic fatigue, static strength, insertion torque, pullout strength, surface area analysis, and bone-to-implant contact analysis.

Technological Characteristics

Materials: Roxolid (Ti-13Zr alloy), Titanium Grade 4 (ISO 5832-2/11), TAN (Ti-6Al-7Nb). Surface: Hydrophilic SLActive. Connection: Conical fitting with Torx-style engagement. Sterilization: Gamma irradiation (implants/caps/healing abutments) or end-user steam sterilization (temporary/Variobase abutments).

Indications for Use

Indicated for endosteal implantation in upper/lower jaw for functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. Suitable for immediate function on single-tooth applications given good primary stability and appropriate occlusal loading.

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

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810 June 5, 2018 Re: K173961 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, NHA Dated: April 30, 2018 Received: May 1, 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 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, Mary S. Runner -S forTina 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) K173961 #### Device Name Straumann® BLX Implant System #### Indications for Use (Describe) #### Straumann® BLX Implants 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 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 Closure Caps and Healing Abutments Straumann® Closure Caps and Healing Abutments are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and to shape, maintain and stabilize the soft tissue during the healing process. Closure caps and healing abutments should be used only with suitable implant connections. Straumann Closure Caps and Healing Abuttnents have a maximum duration of usage of 6 months. #### Straumann® BLX Basal Screws and Temporary 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 abutnents may be placed into occlusion when the implant is fully osseointegrated. BLX Temporary Abutments have a maximum duration of usage of 180 days. #### Straumann® BLX Variobases Straumann® Variobase® prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (crowns) can be cemented onto the Straumann® Variobase® prosthetic components. A temporary restoration can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase; they must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ 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." {4}------------------------------------------------ Straumann® BLX Implant System 510(k) Summary #### 510(k) Summary 5 #### Submitter's Contact Information 5.1 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: June 5, 2018 #### Name of the Device 5.2 | Trade Names: | Straumann® BLX Implant System | |----------------------|-------------------------------| | Common Name: | Endosseous Dental Implant | | Classification Name: | Endosseous Dental Implant | | Regulation Number: | 21 CFR 872.3640 | | Classification: | Class II | | Product Codes: | Primary product code: DZE | | | Secondary product code: NHA | #### 5.3 Predicate Device(s) Primary Predicate: - K150182 Neodent Implant System CM Drive Implants . Reference Devices: - K122855 TL 04.1mm RN,S, SLAcitve TiZr 6, 8, 10, 12, 14, 16mm Dental . Implants - K033922 Device Modification ITI® Dental Implants . {5}------------------------------------------------ ### Straumann® BLX Implant System 510(k) Summary - . K162890 - BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment. - K101545 Genesis Implant System ● - K153624 Neodent Implant System . - K170838 Medentika TiBases . - K130808 Straumann Healing Abutments, Healing Caps, and Closure Screws ● - K092814 Straumann NC Temporary Abutments . - K120822 Straumann® CARES® Variobase™ Abutments . - K170354 Straumann Variobase Abutments ● - K142890 Straumann Variobase Abutment NNC, Straumann Variobase . Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit #### 5.4 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. The prosthetic platforms are identified as RB (Regular Base) and WB (Wide Base). The implants with a RB platform have a "small top/head", and implants with WB platform have a "large top/head", whereas the internal connection is identical for both platform and all the implant diameters and lengths. They are available in the following sizes: | Platform | Neck Ø<br>(mm) | Maximum outer Ø<br>(mm) | Length<br>(mm) | |----------|----------------|-------------------------|----------------| | RB | 3.5 | 4.5 | 6 | | | | | 8 | | | | | 10 | | | | | 12 | | | | | 14 | | | | | 16 | | | | | 18 | | WB | 4.5 | 5.5 | 6 | | | | | 8 | {6}------------------------------------------------ ### Straumann® BLX Implant System 510(k) Summary Image /page/6/Figure/3 description: The image shows a table with several numerical values. The values on the right side of the table are 10, 12, 6, 8, 10, and 12. There is also a value of 6.5 in the middle of the table. The table is divided into several cells by horizontal and vertical lines. The closure cap and healing abutments are manufactured from Titanium Grade 4, per ISO 5832-2 and ISO 5832-11, and are anodized signal violet for the parts compatible with the RB platform and brown for the parts compatible with the WB platform for identification purposes. Closure caps are screwed into the implant to protect the inner configuration and shoulder of the implant during the healing phase in cases of submerged (submucosal) healing. Healing abutments are screwed into the implant to protect the inner configuration in cases of transmucosal healing and are placed out of occlusion. They are available in the following sizes: Closure Caps: | Platform | Gingival<br>heights<br>(mm) | |----------|-----------------------------| | RB/WB | 0.4 | | WB | 0.5 | Healing Abutments: | Platform | Ø<br>(mm) | Gingival<br>heights<br>(mm) | Abutment<br>heights<br>(mm) | |----------|-----------|-----------------------------|-----------------------------| | RB/WB | 4.0 | 1.5 | 2 | | | | | 4 | | | | 2.5 | 2 | | | | | 4 | | RB/WB | 5.0 | 1.5 | 2 | | | | | | | | | 2.5 | 2 | | | | | 4 | | WB | 6.0 | 0.75 | 2 | | | | | | | | | 1.5 | 2 | | | | | 4 | {7}------------------------------------------------ ### Straumann® BLX Implant System | Platform | Ø (mm) | Gingival<br>heights<br>(mm) | Abutment<br>heights<br>(mm) | |----------|--------|-----------------------------|-----------------------------| | RB/WB | 6.5 | 1.5 | 2 | | | | | 4 | | | | 2.5 | 2 | | | | | 4 | | | | 3.5 | 2 | | | | | 4 | | WB | 7.5 | 0.75 | 2 | | | | | 4 | | | | 1.5 | 2 | | | | | 4 | 510(k) Summary The temporary abutments are manufactured from TAN and are anodized signal violet (RB platform) and brown (WB platform) for identification purposes. The temporary abutments are fixed in the implant with a basal screw which is also manufactured from TAN. The basal screw will be delivered with the temporary abutment. They are available in the following sizes: | Platform | Ø (mm) | Gingival heights (mm) | Chimney height (mm) | |----------|--------|-----------------------|---------------------| | RB/WB | 3.8 | 1.5 | | | | | 2.5 | | | RB/WB | 4.5 | 1.5 | | | | | 2.5 | | | RB/WB | 6.0 | 2.5 | 10 | | | | 3.5 | | | WB | 5.5 | 0.75 | | | | | 1.5 | | BLX Variobase abutments is a two-piece abutment ultimately composed by three components: - Variobase™ Abutment (Ti-base) . - Prosthetic restoration (coping and/or crown) . - Basal Screw ● {8}------------------------------------------------ ### Straumann® BLX Implant System 510(k) Summary The BLX Variobase Abutments are manufactured and are delivered with the corresponding basal screw. The prosthetic restoration (crowns) can be cemented onto the Variobase prosthetic components. They are available in the following sizes: | Platform | Ø (mm) | Gingival heights (mm) | Chimney height (mm) | |----------|--------|-----------------------|---------------------| | RB/WB | 3.8 | 1.5 | | | | | 2.5 | | | RB/WB | 4.5 | 1.5 | 5.5 | | | | 2.5 | | | WB | 5.5 | 0.75<br>1.5 | | The BLX Variobase Abutments will be marketed as a stand-alone component or through the CARES® X-Stream™ workflow (prosthetic restoration designed and manufactured through CARES® Visual/validated Straumann milling and then shipped together with the Straumann® BLX Variobase® Abutment and basal screw in the same shipment). All digitally designed copings and/or crowns for use with the BLX Variobase Abutment system are intended to be sent to Straumann for manufacture at a validated milling center. Prosthetic Restoration Design and Materials - . Digital materials: - o IPS e.max CAD MO, LT or HT - o polycon® ae (for temporary restorations) The manufacturing of the coping and/or crown should follow the standard procedure according to the material manufacturer's instructions for use. For digital materials, the following range of modifications is recommended: | | IPS e.max | polycon® | |------------------------|-----------|----------| | | CAD | ae | | Minimum Wall Thickness | 0.7 | 0.5 | | Minimum angulation | 0° | 0° | | Maximum angulation | 30° | 30° | {9}------------------------------------------------ Straumann® BLX Implant System 510(k) Summary Basal screws are used to seat the temporary abutments and the BLX Variobase Abutments to the dental implant, and can be also be used during lab procedures to fix lab prosthetic parts on implant analogs. There is one basal screw for the RB platform and one for the WB platform. They have identical designs and differ only in color-coding (signal violet and brown) to ease the handling. They are provided along the abutments but they are also provided as standalone screws. The BLX basal screws are manufactured from TAN. #### 5.5 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 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. #### Straumann® BLX Closure Caps and Healing Abutments Straumann® Closure Caps and Healing Abutments are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and to shape, maintain and stabilize the soft tissue during the healing process. Closure caps and healing abutments should be used only with suitable implant connections. Straumann Closure Caps and Healing Abutments have a maximum duration of usage of 6 months. {10}------------------------------------------------ ### Straumann® BLX Implant System 510(k) Summary #### Straumann® BLX Basal Screws and Temporary 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. #### Straumann® BLX Variobases Straumann® Variobase® prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (crowns) can be cemented onto the Straumann® Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center. #### 5.6 Technological Characteristics The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following tables: {11}------------------------------------------------ # Straumann® BLX Implant System #### 510(k) Summary | | PROPOSED DEVICE | PRIMARY PREDICATE<br>DEVICE | REFERENCE PREDICATE DEVICES | | EQUIVALENCE | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FEATURE | Subject Device - BLX<br>Implants | K150182<br>Neodent Implant System | K122855<br>Straumann Implant System | K101545<br>Genesis Implant System | DISCUSSION | | Indications<br>for Use | Straumann® BLX Implants<br>are suitable for endosteal<br>implantation in the upper<br>and lower jaw and for the<br>functional and esthetic oral<br>rehabilitation of edentulous<br>and partially edentulous<br>patients. BLX Implants can<br>be placed with immediate<br>function on single-tooth<br>applications when good<br>primary stability is achieved<br>and with appropriate<br>occlusal loading to restore<br>chewing function. The<br>prosthetic restorations are<br>connected to the implants<br>through the corresponding<br>abutment components. | The Neodent Implant System<br>is intended to be surgically<br>placed in the bone of the<br>upper or lower jaw to provide<br>support for prosthetic<br>devices such as artificial<br>teeth, to restore chewing<br>function. It may be used with<br>single-stage or two-stage<br>procedures, for single or<br>multiple unit restorations,<br>and may be loaded<br>immediately when good<br>primary stability is achieved<br>and with appropriate occlusal<br>loading. | Straumann® dental implants are<br>suitable for the treatment of oral<br>endosteal implantation in the upper<br>and lower jaw and for the<br>functional and esthetic oral<br>rehabilitation of edentulous and<br>partially dentate patients (unless<br>specific indications and limitations<br>are present, as stated below).<br>Straumann® dental Implants can<br>also be used for Immediate or<br>early, Implantation following<br>extraction or loss of natural teeth.<br>Implants can be placed with<br>immediate function on single-tooth<br>and/or multiple tooth applications<br>when good primary stability is<br>achieved and with appropriate<br>occlusal loading, to restore<br>chewing function. The prosthetic<br>restorations used are single<br>crowns, bridges and partial or full<br>dentures, which are connected to<br>the Implants by the corresponding<br>elements (abutments). When<br>placing implants in the posterior<br>region, we recommend using only<br>large diameter implants. In cases<br>of fully edentulous patients, 4 or<br>more implants must be used in<br>immediately loaded cases. | The Genesis Implant System<br>is intended for use in single-<br>stage or two-stage surgical<br>procedures in all types of<br>bone in partially or fully<br>edentulous mandibles and<br>maxillae. The Genesis Implant<br>System supports single or<br>multiple-unit restorations to re-<br>establish patient chewing<br>function and esthetics.<br>Genesis implants are intended<br>for placement following<br>natural tooth loss or for<br>immediate placement into an<br>extraction socket. Immediate<br>function may be achieved<br>when good primary stability is<br>established and appropriate<br>occlusal loading is applied. | The subject implants<br>have the same<br>indication as the primary<br>predicate device<br>K150182. Only minor<br>differenes in wording<br>that do not affect the<br>intended use. | | Material | Titanium-13 Zirconium<br>alloy (Roxolid®) | Ti Grade 4 | Titanium-13 Zirconium alloy<br>(Roxolid®) | Ti Grade 4 | Identical to reference<br>device K122855. | | | PROPOSED DEVICE | PRIMARY PREDICATE<br>DEVICE | REFERENCE PREDICATE DEVICES | | EQUIVALENCE<br>DISCUSSION | | FEATURE | Subject Device – BLX | K150182 | K122855 | K101545 | | | | Implants | Neodent Implant System | Straumann Implant System | Genesis Implant System | | | Surface<br>Treatment | Hydrophilic SLActive® | Neoporos and<br>Acqua (hydrophilic) | Hydrophilic SLActive® | Hydrophilic surface enriched<br>with calcium and<br>phosphorous ions | Identical to the<br>primary prediate. | | Implant to<br>Abutment<br>Connection | BLX<br>(with conical fitting) | CM<br>(with conical fitting) | Synocta<br>(with conical fitting) | TiLobe™ | The subject devices<br>have a conical implant-<br>to-abutment fitting as<br>well as K150182 and<br>K122855 devices,<br>nevertheless, each<br>implant system has its<br>own engaging feature<br>in the conical<br>connection. | | Implant<br>Diameter | Ø 4.5, 5.5, 6.5 mm | Ø 3.5, 4.3 and 5.0 mm | Ø 4.1 mm and 4.8 mm | Ø 3.8 to 6.5 mm | In the range of<br>diameters of the<br>primary predicate and<br>the reference devices. | | Implant<br>Length | 6 to 18 mm | 18 mm | 6 to 16 mm | 8.5 to 18 mm | In the range of lengths<br>of the primary<br>predicate and the<br>reference devices. | | Implant<br>Body | Tapered body | Tapered body | Straight body | Straight and tapered body | Identical to primary<br>predicate and one of<br>the reference devices. | | Thread<br>Pitch | 2.0 to 2.8 mm | 2.2 mm | 1.25 mm | Information not available | Similar to device<br>K150182. Both<br>implants have threads<br>designed to provide<br>proper primary stability<br>and allows for<br>immediate loading. | | FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE<br>DEVICE | REFERENCE PREDICATE DEVICES | | EQUIVALENCE<br>DISCUSSION | | | Subject Device – BLX<br>Implants | K150182<br>Neodent Implant System | K122855<br>Straumann Implant System | K101545<br>Genesis Implant System | | | Sterilizatio<br>n Method | Irradiation | Irradiation | Irradiation | Irradiation | Identical. | {12}------------------------------------------------ # Straumann® BLX Implant System 510(k) Summary {13}------------------------------------------------ # Straumann® BLX Implant System 510(k) Summary Table 1 - Comparison of subject device versus primary predicate device (Dental Implants) {14}------------------------------------------------ # Straumann® BLX Implant System 510(k) Summary | FEATURE | PROPOSED DEVICE | REFERENCE PREDICATE<br>DEVICE | EQUIVALENCE<br>DISCUSSION | |--------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device - BLX Healing<br>components | K130808 | | | Material | Titanium Grade 4<br>according to ISO 532-2 and<br>ISO 5832-11 | Titanium Grade 4 | Identical material. | | Implant to<br>Abutment<br>Connection | BLX<br>(with conical fitting) | Synocta<br>CrossFit<br>(with conical fitting) | The subject devices<br>have a conical<br>implant-to-abutment<br>fitting as well as the<br>reference devices,<br>nevertheless, each<br>implant system has its<br>own engaging feature<br>in the conical<br>connection. | | Prosthetic<br>Platform<br>Diameter | Closure Cap: NA<br>Healing Abutments:<br>Ø 4, 5, 6, 6.5 and 7.5 mm | Closure Cap: NA<br>Healing Abutment:<br>Ø 3.3 to 6.5 mm | Mostly into the range<br>of the reference device<br>diameters. 7.5 mm of<br>diameter does not<br>raise new safety issue. | | Abutment<br>Heights | Closure Cap:<br>0.4 and 0.5 mm<br>Healing Abutments:<br>2.75 to 7.5 mm | Closure Cap:<br>0 mm and 1.5 mm<br>Healing Abutments:<br>2.0 to 7.0 mm | The heights of the<br>subject devices are<br>mostly into the range<br>of the reference<br>device. Some healing<br>abutments are 0.5mm<br>higher in order to<br>cover different clinical<br>situations and do not<br>introduce new safety<br>issue. | | Sterilizatio<br>n Method | Irradiation | Irradiation | Identical to the<br>reference device. | Table 2 - Comparison of subject device versus reference device (BLX Closure Cap and BLX Healing Abutments) {15}------------------------------------------------ # Straumann® BLX Implant System 510(k) Summary | FEATURE | PROPOSED DEVICE | REFERENCE PREDICATE DEVICE | EQUIVALENCE DISCUSSION | |--------------------------------------|---------------------------------------------|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device – BLX<br>Temporary Abutments | K092814<br>Straumann implant system | | | Material | Ti-6Al-7Nb | Ti-6Al-7Nb | Identical | | Implant to<br>Abutment<br>Connection | BLX<br>(with conical fitting) | CrossFit® (NC)<br>(with conical fitting) | The subject devices<br>have a conical implant-<br>to-abutment fitting as<br>well as the reference<br>devices, nevertheless,<br>each implant system<br>has its own engaging<br>feature in the conical<br>connection. | | Diameter | Ø 3.8, 4.5, 5.5 and 6 mm | Ø3.5 mm | The subject devices<br>have larger diameters<br>in order to match with<br>the diameters of the<br>new BLX implants.<br>Larger diameters do<br>not introduce a new<br>worst case in terms of<br>performance. | | Gingival<br>Heights | 0.75, 1.5, 2.5 and 3.5 mm | 1.0 mm | The different gingival<br>heights are intended to<br>cover different clinical<br>situations and do not<br>introduce new safety<br>issue. | | Chimney<br>Heights | 10 mm | 10 mm | Identical. | | Angulation | Straight | Straight | Identical. | | Sterilization<br>Method | Non-sterile/<br>End user sterilized | Non-sterile/<br>End user sterilized | Identical. | Table 3 - Comparison of subject device versus reference predicate device (BLX Temporary Abutments) {16}------------------------------------------------ # Straumann® BLX Implant System 510(k) Summary | FEATURE | PROPOSED DEVICE | REFERENCE PREDICATE DEVICE | REFERENCE PREDICATE DEVICE…
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%