(159 days)
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 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® 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.
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.
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.
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.
BLX Variobase abutments is a two-piece abutment ultimately composed by three components: Variobase™ Abutment (Ti-base), Prosthetic restoration (coping and/or crown), and Basal Screw. 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.
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.
This document describes the Straumann® BLX Implant System, a dental implant system, and its various components. The information provided is for a 510(k) premarket notification to the FDA. The goal is to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than setting and meeting specific, quantitative acceptance criteria for novel performance. Instead, the "acceptance criteria" are implied by successful comparative testing and adherence to existing standards and guidance documents. The "reported device performance" is the outcome of these tests.
| Test Type | Implied Acceptance Criteria (Demonstrated by Equivalence/Compliance) | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Achieves a Sterility Assurance Level (SAL) of 10⁻⁶ via gamma irradiation. Complies with ISO 11137-1:2006 and ISO 11137-2:2013. For end-user sterilized components, validation according to ISO 17665-1, ISO 17665-2, and FDA guidance "Reprocessing Medical Devices in Health Care Settings." | BLX implants, closure caps, and healing abutments are sterile via gamma irradiation (25 kGy minimum), validated to SAL 10⁻⁶ per ISO 11137-1:2006 and ISO 11137-2:2013 (overkill bioburden method). BLX Temporary Abutments and BLX Variobase Abutments are end-user sterilized by moist heat (steam), validated per ISO 17665-1, ISO 17665-2, and FDA reprocessing guidance. |
| Shelf Life | Packaging ensures maintaining sterility for a specified period and materials are not adversely affected. | Shelf life for sterile devices remains 5 years, as packaging is equivalent to predicate/reference devices and materials are not adversely affected by time. |
| Pyrogenicity | Meets pyrogen limit specifications based on LAL Endotoxin Analysis (e.g., < 20 EU/device). | Pyrogenicity determined by LAL Endotoxin Analysis, with a testing limit of 20 EU/device for blood contacting and implanted devices. |
| Biocompatibility | Complies with ISO 10993-1:2009 and FDA guidance "Use of International Standard ISO 10993-1." Equivalent nature of body contact, contact duration, material formulation, and sterilization methods compared to predicates. | Biological assessment performed per ISO 10993-1:2009 and FDA guidance. Subject devices have equivalent body contact, duration, material formulation, and sterilization methods compared to predicates. Differences in manufacturing assessed via Chemical Characterization and Cytotoxicity tests. |
| Dynamic Fatigue & Static Strength | Fatigue load limits are equivalent to reference devices, especially for worst-case configurations. | Tests performed according to FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." Both RB and WB platforms, for worst-case considerations, proved equivalent to reference devices. |
| Insertion Torque | Allows reaching suitable implant insertion torques. | Tests conducted on worst-case defined for each diameter (Ø4.5, Ø 5.5, Ø 6.5 mm) of the BLX portfolio (shortest, middle, longest implants). Demonstrated that BLX Implants and related cutting instruments allow reaching suitable implant insertion torques. |
| Pullout Strength, Surface Area, B-I Contact | Equivalent to reference devices. | Performed for 6mm long BLX implants with Ø 4.5, 5.5, and 6.5 mm. Equivalency to reference devices was demonstrated. |
| Software Verification & Validation | Complies with FDA guidance documents for CAD/CAM systems and general software validation. Software functions correctly within the digital workflow. | Conducted and documented according to FDA guidance documents "Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations" and "General Principles of Software Validation; Final Guidance for Industry and FDA Staff." Software considered "moderate" level of concern. Implementation verification shows Variobase devices and modeling components work together within the digital workflow for copings/crowns. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state numerical sample sizes for most bench tests (e.g., fatigue, insertion torque, pullout strength). It refers to "worst case considerations" for selecting test configurations (e.g., shortest, middle, and longest implants for insertion torque; both RB and WB platforms for fatigue). This implies a representative selection but not a specific count.
The data provenance is not explicitly stated as "country of origin." However, as this is an FDA submission for a device from "Institut Straumann AG" and "Straumann USA, LLC" (Andover, Massachusetts), the testing would typically be conducted in facilities compliant with US/international standards relevant to medical device approval, likely either in the US or Europe where Straumann has its main operations. The tests are retrospective, as they are being submitted to demonstrate the device meets prior requirements for market clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this document. The document describes a medical device (dental implants and components) and its engineering and biological testing, not an AI/diagnostic software. Therefore, there is no "ground truth" to be established by experts in the context of diagnostic interpretation, and no test set in that specific sense.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3. There is no diagnostic "test set" requiring adjudication by multiple readers or experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This document describes a physical medical device (dental implants), not an AI-assisted diagnostic or clinical decision support tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This document describes a physical medical device and some associated software for design/milling, not a standalone AI algorithm with performance metrics.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the engineering tests (fatigue, strength, torque, pullout), the "ground truth" is defined by established engineering and material science principles, industry standards (e.g., ISO, ASTM, FDA guidance), and the performance of legally marketed predicate devices. The "truth" is whether the device meets the performance requirements set forth by these standards and demonstrates equivalence to existing, safe, and effective devices. For biocompatibility, the ground truth is compliance with ISO 10993 standards and a lack of adverse biological reactions.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical dental implant system, not an AI model that requires a "training set." The software mentioned is for CAD/CAM and is validated, not "trained" in the machine learning sense.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as point 8.
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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.
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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); 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
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Indications for Use
510(k) Number (if known)
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.
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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 .
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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(mm) | Maximum outer Ø(mm) | Length(mm) |
|---|---|---|---|
| RB | 3.5 | 4.5 | 6 |
| 8 | |||
| 10 | |||
| 12 | |||
| 14 | |||
| 16 | |||
| 18 | |||
| WB | 4.5 | 5.5 | 6 |
| 8 |
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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 | Gingivalheights(mm) |
|---|---|
| RB/WB | 0.4 |
| WB | 0.5 |
Healing Abutments:
| Platform | Ø(mm) | Gingivalheights(mm) | Abutmentheights(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 |
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Straumann® BLX Implant System
| Platform | Ø (mm) | Gingivalheights(mm) | Abutmentheights(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 ●
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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 | 0.751.5 |
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° |
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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.
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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:
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Straumann® BLX Implant System
510(k) Summary
| PROPOSED DEVICE | PRIMARY PREDICATEDEVICE | REFERENCE PREDICATE DEVICES | EQUIVALENCE | ||
|---|---|---|---|---|---|
| FEATURE | Subject Device - BLXImplants | K150182Neodent Implant System | K122855Straumann Implant System | K101545Genesis Implant System | DISCUSSION |
| Indicationsfor Use | Straumann® BLX Implantsare suitable for endostealimplantation in the upperand lower jaw and for thefunctional and esthetic oralrehabilitation of edentulousand partially edentulouspatients. BLX Implants canbe placed with immediatefunction on single-toothapplications when goodprimary stability is achievedand with appropriateocclusal loading to restorechewing function. Theprosthetic restorations areconnected to the implantsthrough the correspondingabutment components. | The Neodent Implant Systemis intended to be surgicallyplaced in the bone of theupper or lower jaw to providesupport for prostheticdevices such as artificialteeth, to restore chewingfunction. It may be used withsingle-stage or two-stageprocedures, for single ormultiple unit restorations,and may be loadedimmediately when goodprimary stability is achievedand with appropriate occlusalloading. | Straumann® dental implants aresuitable for the treatment of oralendosteal implantation in the upperand lower jaw and for thefunctional and esthetic oralrehabilitation of edentulous andpartially dentate patients (unlessspecific indications and limitationsare present, as stated below).Straumann® dental Implants canalso be used for Immediate orearly, Implantation followingextraction or loss of natural teeth.Implants can be placed withimmediate function on single-toothand/or multiple tooth applicationswhen good primary stability isachieved and with appropriateocclusal loading, to restorechewing function. The prostheticrestorations used are singlecrowns, bridges and partial or fulldentures, which are connected tothe Implants by the correspondingelements (abutments). Whenplacing implants in the posteriorregion, we recommend using onlylarge diameter implants. In casesof fully edentulous patients, 4 ormore implants must be used inimmediately loaded cases. | The Genesis Implant Systemis intended for use in single-stage or two-stage surgicalprocedures in all types ofbone in partially or fullyedentulous mandibles andmaxillae. The Genesis ImplantSystem supports single ormultiple-unit restorations to re-establish patient chewingfunction and esthetics.Genesis implants are intendedfor placement followingnatural tooth loss or forimmediate placement into anextraction socket. Immediatefunction may be achievedwhen good primary stability isestablished and appropriateocclusal loading is applied. | The subject implantshave the sameindication as the primarypredicate deviceK150182. Only minordifferenes in wordingthat do not affect theintended use. |
| Material | Titanium-13 Zirconiumalloy (Roxolid®) | Ti Grade 4 | Titanium-13 Zirconium alloy(Roxolid®) | Ti Grade 4 | Identical to referencedevice K122855. |
| PROPOSED DEVICE | PRIMARY PREDICATEDEVICE | REFERENCE PREDICATE DEVICES | EQUIVALENCEDISCUSSION | ||
| FEATURE | Subject Device – BLX | K150182 | K122855 | K101545 | |
| Implants | Neodent Implant System | Straumann Implant System | Genesis Implant System | ||
| SurfaceTreatment | Hydrophilic SLActive® | Neoporos andAcqua (hydrophilic) | Hydrophilic SLActive® | Hydrophilic surface enrichedwith calcium andphosphorous ions | Identical to theprimary prediate. |
| Implant toAbutmentConnection | BLX(with conical fitting) | CM(with conical fitting) | Synocta(with conical fitting) | TiLobe™ | The subject deviceshave a conical implant-to-abutment fitting aswell as K150182 andK122855 devices,nevertheless, eachimplant system has itsown engaging featurein the conicalconnection. |
| ImplantDiameter | 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 ofdiameters of theprimary predicate andthe reference devices. |
| ImplantLength | 6 to 18 mm | 18 mm | 6 to 16 mm | 8.5 to 18 mm | In the range of lengthsof the primarypredicate and thereference devices. |
| ImplantBody | Tapered body | Tapered body | Straight body | Straight and tapered body | Identical to primarypredicate and one ofthe reference devices. |
| ThreadPitch | 2.0 to 2.8 mm | 2.2 mm | 1.25 mm | Information not available | Similar to deviceK150182. Bothimplants have threadsdesigned to provideproper primary stabilityand allows forimmediate loading. |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATEDEVICE | REFERENCE PREDICATE DEVICES | EQUIVALENCEDISCUSSION | |
| Subject Device – BLXImplants | K150182Neodent Implant System | K122855Straumann Implant System | K101545Genesis Implant System | ||
| Sterilization Method | Irradiation | Irradiation | Irradiation | Irradiation | Identical. |
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Straumann® BLX Implant System
510(k) Summary
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Straumann® BLX Implant System
510(k) Summary
Table 1 - Comparison of subject device versus primary predicate device (Dental Implants)
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Straumann® BLX Implant System
510(k) Summary
| FEATURE | PROPOSED DEVICE | REFERENCE PREDICATEDEVICE | EQUIVALENCEDISCUSSION |
|---|---|---|---|
| Subject Device - BLX Healingcomponents | K130808 | ||
| Material | Titanium Grade 4according to ISO 532-2 andISO 5832-11 | Titanium Grade 4 | Identical material. |
| Implant toAbutmentConnection | BLX(with conical fitting) | SynoctaCrossFit(with conical fitting) | The subject deviceshave a conicalimplant-to-abutmentfitting as well as thereference devices,nevertheless, eachimplant system has itsown engaging featurein the conicalconnection. |
| ProstheticPlatformDiameter | Closure Cap: NAHealing Abutments:Ø 4, 5, 6, 6.5 and 7.5 mm | Closure Cap: NAHealing Abutment:Ø 3.3 to 6.5 mm | Mostly into the rangeof the reference devicediameters. 7.5 mm ofdiameter does notraise new safety issue. |
| AbutmentHeights | Closure Cap:0.4 and 0.5 mmHealing Abutments:2.75 to 7.5 mm | Closure Cap:0 mm and 1.5 mmHealing Abutments:2.0 to 7.0 mm | The heights of thesubject devices aremostly into the rangeof the referencedevice. Some healingabutments are 0.5mmhigher in order tocover different clinicalsituations and do notintroduce new safetyissue. |
| Sterilization Method | Irradiation | Irradiation | Identical to thereference device. |
Table 2 - Comparison of subject device versus reference device (BLX Closure Cap and
BLX Healing Abutments)
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Straumann® BLX Implant System
510(k) Summary
| FEATURE | PROPOSED DEVICE | REFERENCE PREDICATE DEVICE | EQUIVALENCE DISCUSSION |
|---|---|---|---|
| Subject Device – BLXTemporary Abutments | K092814Straumann implant system | ||
| Material | Ti-6Al-7Nb | Ti-6Al-7Nb | Identical |
| Implant toAbutmentConnection | BLX(with conical fitting) | CrossFit® (NC)(with conical fitting) | The subject deviceshave a conical implant-to-abutment fitting aswell as the referencedevices, nevertheless,each implant systemhas its own engagingfeature in the conicalconnection. |
| Diameter | Ø 3.8, 4.5, 5.5 and 6 mm | Ø3.5 mm | The subject deviceshave larger diametersin order to match withthe diameters of thenew BLX implants.Larger diameters donot introduce a newworst case in terms ofperformance. |
| GingivalHeights | 0.75, 1.5, 2.5 and 3.5 mm | 1.0 mm | The different gingivalheights are intended tocover different clinicalsituations and do notintroduce new safetyissue. |
| ChimneyHeights | 10 mm | 10 mm | Identical. |
| Angulation | Straight | Straight | Identical. |
| SterilizationMethod | Non-sterile/End user sterilized | Non-sterile/End user sterilized | Identical. |
Table 3 - Comparison of subject device versus reference predicate device (BLX Temporary Abutments)
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Straumann® BLX Implant System
510(k) Summary
| FEATURE | PROPOSED DEVICE | REFERENCE PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | EQUIVALENCE DISCUSSION |
|---|---|---|---|---|
| Subject Device - BLXVariobase Abutments | K170838Medentika TiBases | K142890 and K170354Straumann implant system | ||
| Material | Ti-6Al-7Nb | Ti-6Al-4V | Ti-6Al-7Nb | Identical to referencedevice K142890. |
| Implant toAbutmentConnection | BLX(with conical fitting) | Several, according to theimplant lines referred in theIndications for Use statement | CrossFit® (SC)(with conical fitting) | The subject deviceshave a conicalimplant-to-abutmentfitting as well as theStraumann referencedevices,nevertheless, eachimplant system has itsown engaging featurein the conicalconnection. |
| ProstheticPlatformDiameter | diameter 3.8, 4.5, and 5.5 mm | diameter 3.25 to 6.0 mm | diameter 3.9 and 7.0 mm | Into the range of thereference devices. |
| Gingival Heights | 0.75 - 2.5 mm | 0.3 - 1.15 mm | 2.0 and 3.0 mm | Into the range of thereference devices. |
| Chimney Heights | 5.5 mm(can be reduced) | 3.5 and 5.5 mm | 3.5 and 5.5 mm | Into the range of thereference devices. |
| Design Workflow | Wax-up orStraumann CARES® Visual,Dental Wings software usingthe Straumann CARES VisualPlug-In and 3Shape | Straumann CARES System | Wax-up orStraumann CARES® Visual,Dental Wings software usingthe Straumann CARES VisualPlug-In and 3Shape | Identical to theStraumann referencedevices. |
| ManufacturingWorkflow | Straumann Milling | Straumann Milling | Traditional casting or pressingorStraumann Milling | Into the range of thereference devices. |
| FEATURE | PROPOSED DEVICE | REFERENCE PREDICATE DEVICE | EQUIVALENCE DISCUSSION | |
| Subject Device - BLXVariobase Abutments | K170838Medentika TiBases | K142890 and K170354Straumann implant system | ||
| Coping/ CrownMaterial | Digital materials:IPS e.max CADPolycon® ae | ZirconiaIPS e.max CAD | Cast materials:Type 4 metals (ISO 22674)Press materials:IPS e.max® Press CeramicDigital materials:Coron®Zerion®IPS e.max CADn!cePolycon® ae | Into the range of thereference devices. |
| Coping/ CrownAngulation | Up to 30° | Up to 30° | Up to 30° | Identical. |
| SterilizationMethod | Non-sterile/End user sterilized | Non-sterile/End user sterilized | Non-sterile/End user sterilized | Identical to thereference devices. |
| Mode of Action | Screw-retained or cementretained | Screw-retained or cementretained | Screw-retained or cementretained | Identical to thereference devices. |
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Straumann® BLX Implant System
510(k) Summary
Table 4 - Comparison of subject device versus reference device (BLX Variobase Abutments)
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Straumann® BLX Implant System
510(k) Summary
5.7 Performance Testing
The following performance data were provided in support of the substantial equivalence determination.
5.7.1 Sterilization Validation and Shelf Life
The BLX implants, closure caps and healing abutments are provided sterile via gamma irradiation at a dose of 25 kilogray (2.5 Mrad) minimum. A sterility assurance level (SAL) of 10° had been validated in accordance with ISO 11137-1:2006, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, 2006-04-05. The validation method used was the over kill bioburden method in accordance with ISO 11137-2:2013, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose.
The BLX Temporary Abutments and BLX Variobase Abutments needs to be end-user sterilized by moist heat (steam). The recommended sterilization has been validated according to ISO 17665-1 and ISO 17665-2 and to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". There are no changes to the sterilization procedures or processes from those of the Straumann predicate devices. The packaging of all BLX devices is equivalent to the packaging of the predicate and reference device and so the shelf life for sterile devices remains to be 5 years since the materials are not adversely affected by the time.
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.
5.7.2 Biocompatibility Testing
Biological assessment has been performed according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and to the FDA Guidance document "Use of International Standard ISO 10993- 1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016" for each of the subject devices.
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Straumann® BLX Implant System
510(k) Summary
The subject devices have the equivalent nature of body contact, contact duration, material formulation and sterilization methods compared to the primary and reference predicate devices. Differences in the manufacturing process have been assessed via Chemical Characterization and Cytotoxicity tests.
5.7.3 Bench Testing
Dynamic fatigue, static strength, insertion torque tests, pullout strength tests, surface area analysis, and bone-to-implant contact analysis were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the Straumann BLX Implant System is equivalent to the predicate 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 proved equivalent to the reference devices.
Insertion torque tests were conducted on the worst case defined for each diameter (Ø4.5, Ø 5.5 and Ø 6.5 mm) of the BLX portfolio: the shortest implant (6 mm), the middle length implant (12 mm) and the longest implant (18 mm). With this test, it was demonstrated that the BLX Implants and the related cutting instruments allow reaching suitable implant insertion torques.
Pullout strength tests, surface area analysis and bone-to-implant contact analysis were performed for the 6mm long BLX implants with Ø 4.5, 5.5 and 6.5 mm and equivalency to the reference devices was demonstrated.
5.7.4 Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided according to the FDA guidance documents "Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations" and "General Principles of Software Validation; Final Guidance for Industry and FDA Staff". The software for this device was considered as a "moderate" level of concern.
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Straumann® BLX Implant System
510(k) Summary
Also, software implementation verification provided demonstrates that all subject Variobase devices plus the modeling components within the new BLX portfolio are suitable to work together into the defined digital workflow to produce copings or crowns that properly fit and compose the final two-piece abutment.
5.7.5 Clinical data
No device specific clinical data has been submitted to demonstrate substantial equivalence.
5.8 Conclusion
The documentation submitted in this premarket notification demonstrates the Straumann® BLX implants, BLX Closure Caps and Healing Abutments, BLX Temporary Abutments, and Variobase Abutments are substantially equivalent to the primary predicate and reference devices.
§ 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.