(90 days)
Straumann BLX Healing Abutments for Bars and Bridges: Straumann 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 form, maintain and stabilize the soft tissue during the healing process. Healing abutments should be used only with suitable implant connections. Healing components have a maximum duration of usage of 6 months.
Straumann BLX Temporary Abutments for Bars and Bridges: 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 Variobase Abutments for Bar and Bridges: 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 (bridge or overdenture) can be cemented on the Straumann® Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.
Straumann BLX Variobase Abutments AS: The Straumann Variobase for Crown AS is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann Variobase for Crown AS are indicated for screw retained single tooth or cement-retained single tooth and bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. All digitally designed copings and/or crowns for use with the Straumann Variobase for Crown AS are intended to be sent to Straumann for manufacture at a validated milling center.
Straumann BLX Novaloc Abutments: The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants.
Straumann BLX CARES Abutments: The Straumann CARES Abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.
BLX Healing Abutments for Bars and Bridges: Healing abutments are screwed into the implant in cases of transmucosal healing to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. They are placed out of occlusion and have a maximum duration of usage of 180 days. Unlike the predicate RB/WB healing abutments (K173961), the subject healing abutments are intended to shape the soft tissue for posterior placement of bridge restorations instead of single crowns. The subject healing abutments are manufactured from Titanium Grade 4 and are anodized in violet.
BLX Temporary Abutments for Bars and Bridges: Temporary Abutments are intended to be placed into Straumann dental implants to provide support for temporary restorations. 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, as well as provide a temporary esthetic solution. They support a temporary restoration and may not be placed into of occlusion. Straumann BLX Temporary Abutments have a maximum duration of usage of 180 days. Unlike the predicate RB/WB temporary abutments (K173961), the subject temporary abutments are intended to shape the soft tissue for posterior placement of bridge restorations instead of sinqle crowns. The subject temporary abutment cannot be shortened. The Temporary abutment for bar/bridge is a non-engaging device intended to support multiple-unit restoration. The subject temporary abutment is manufactured from TAN and is anodized in violet. The temporary abutments are fixed in the implant by means of a basal screw which is also manufactured from TAN.
BLX Variobase Abutments for Bars and Bridges: Variobase Abutments for Bars and Bridges are intended to be placed into Straumann implants to provide support for multi-unit restorations. The prosthetic restoration (bar/bridge) must be cemented onto the Variobase abutments, which is then screwed onto the implants. 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. Unlike the predicate Variobase abutments (K173968), the subject Variobase abutments present 3 retention features in the chimney instead of 4. The Variobase abutments for bar/bridges are non-engaging devices intended to support multiple-unit restorations. The subject Variobase abutments are manufactured from TAN and are anodized in violet. The Variobase abutments are fixed in the implant by means of a basal screw which is also manufactured from TAN.
BLX Variobase Abutments AS for Crowns: Variobase abutments AS for crowns are intended to be placed into Straumann implants to provide support for single-unit restorations. The prosthetic restoration (crown) must be cemented onto the Variobase abutment, which is then screwed onto the implant. 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. The Variobase abutments are manufactured from TAN and are anodized in violet or in brown according to the compatible BLX implant platform (RB/WB or RB). Unlike the predicate Variobase abutments (K173961/K173379), the subject Variobase abutments present 3 retention features in the chimney instead of 4. The chimney presents a cutout window to facilitate the handling of the screw driver in an angulated position. The Variobase abutments AS for crown are engaging devices intended to support single-unit restorations. The Variobase abutments are fixed in the implant by means of a basal screw which is also manufactured from TAN. The Variobase abutments for crown AS are titanium bases to be used as the lower part of two-piece abutments. The upper part of the two-piece abutment is a CAD/CAM designed and manufactured restoration. The planning and milling of the customized restoration must be made using the validated Straumann CARES Visual, Dental Wings software using the Straumann CARES Visual Plug-In. All digitally designed copings and/or crowns for use on the Variobase abutments are intended to be manufactured at a validated milling center.
BLX Novaloc Abutments: Novaloc Abutments are intended to be placed into Straumann dental implants to provide support for full arch detachable restorations (over-denture). The Novaloc abutments are manufactured from TAV (Ti-6Al-4V, Titanium-Aluminum-Vanadium) and are anodized in violet. The restoration is connected to the Novaloc abutment through a snap-on fixture provided by a negative shape of Novaloc snap-on fixture embedded into the final restoration. The snap-on feature is TiN coated. Unlike the reference Novaloc abutments (K173902), the subject Novaloc abutments are not only provided in a straight version but also angulated. The Novaloc abutments are provided non-sterile with instructions for end user sterilization. Angled models: are composed of an abutment body with a coupled basal screw. They are engaging devices. Straight models: both body and thread parts are machined in one piece. They are nonengaging devices.
BLX CARES Abutments: CARES Abutments are intended to be placed into Straumann implants to provide support for prosthetic reconstructions such as crowns and bridges. The final abutment, fabricated from a pre-milled blank, is designed to allow for individual customization regarding function and esthetics. The blank, manufactured from TAN and CoCr, is composed of a pre-milled implant-toabutment connection (TorcFit) and a cylindrical body with enough material volume to create a wide range of geometries for the final abutment. Inside the abutment, a screw channel provides access to the internal thread feature of the implant, such that the component can be firmly attached while providing fit between screw, abutment and implant. The planning and milling of the customized restoration must be made using the validated Straumann CARES Visual, Dental Wings software using the Straumann CARES Visual Plug-In. The maximum angulation allowed is 30° and the minimum wall thickness allowed is 0.4 mm. All digitally designed abutments are intended to be manufactured at a validated milling center.
BLX Basal Screws: Basal screws are used to fix abutments to dental implant, and can also be used during lab procedures to fix lab prosthetic parts on implant analogs. They are provided along the abutments and also provided as standalone screws. The subject Basal Screws are manufactured from TAN. The Basal Screw for Variobase AS is anodized in green since this color identifies Straumann devices pertaining to AS system.
The provided 510(k) summary for the Straumann® BLX Line Extension - New Abutments is a pre-market notification to the FDA. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than proving the device meets acceptance criteria through a traditional clinical study with defined performance targets.
Instead of "acceptance criteria," the focus here is on bench testing performance demonstrating fundamental material and structural integrity compared to predicate devices, and lack of significant differences in technological characteristics and indications for use.
Therefore, the requested information elements related to clinical studies, test sets, ground truth, and expert adjudication are not applicable in the context of this 510(k) summary, as no device-specific clinical data has been submitted to demonstrate substantial equivalence. The submission relies on performance data from bench testing and biocompatibility assessments to support the claim of substantial equivalence.
Here's the information that can be extracted from the provided text, re-interpreting "acceptance criteria" as the comparable characteristics to predicate devices and "reported device performance" as the results of the bench and biocompatibility tests.
Acceptance Criteria and Study Details for Straumann® BLX Line Extension - New Abutments
As this is a 510(k) submission primarily relying on substantial equivalence to predicate devices, the concept of "acceptance criteria" is less about meeting specific numerical performance targets in a clinical setting and more about demonstrating that the new devices do not raise new questions of safety or effectiveness. The study supporting this is primarily bench testing and biocompatibility assessments, rather than a clinical trial.
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for a 510(k) are implicitly that the new device's technological characteristics and performance are substantially equivalent to a predicate device, without raising new questions of safety or effectiveness. The "reported device performance" refers to the results of the bench tests and sterility/biocompatibility validations.
| Characteristic / "Acceptance Criteria" | Reported Device Performance (Summary) | Supporting Study/Method |
|---|---|---|
| Technological Characteristics | Equivalent or minor differences from predicate devices (e.g., material, connection type, dimensions). Differences found to be non-significant. | Comparison matrices (Tables 1-6) against predicate and reference devices. |
| Material Biocompatibility | Biologically safe. | Biocompatibility testing according to ISO 10993-1:2009 and FDA Guidance. |
| Sterilization Efficacy | Achieves SAL of 10^-6 (for sterile products). | Validation according to ISO 11137-1:2006 and ISO 11137-2:2013 (for healing abutments), and ISO 17665-1/2 for end-user sterilization. |
| Pyrogenicity | Meets pyrogen limit specifications (<20 EU/device). | LAL Endotoxin Analysis based on FDA Guidance. |
| Mechanical Performance | Equivalent dynamic fatigue and static strength to predicate devices. | Dynamic fatigue and static strength tests according to FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." |
| Shelf Life | 5 years (for sterile products). | Packaging equivalence to predicate, material stability over time. |
2. Sample sized used for the test set and the data provenance
The document does not specify exact sample sizes for each individual bench test (e.g., number of abutments tested for fatigue). It states that dynamic fatigue and static strength tests were conducted, which typically involve a sufficient number of samples to generate statistically sound data according to the relevant standards.
- Sample Size: Not explicitly stated for each test. The studies were conducted according to recognized international standards (ISO) which dictate appropriate sample sizes for testing.
- Data Provenance: The tests were conducted internally or by contracted labs by Straumann USA, LLC (on behalf of Institut Straumann AG), and the data was submitted to the FDA as part of the 510(k) submission. This is not patient-derived data; it's laboratory bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a clinical study involving expert interpretation or "ground truth" establishment in a diagnostic context. The "truth" in this context is adherence to engineering specifications and regulatory standards.
4. Adjudication method for the test set
Not applicable. This is not a clinical study involving expert adjudication.
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
Not applicable. This device is a dental implant abutment, not an AI-powered diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental implant abutment, not an algorithm.
7. The type of ground truth used
For bench testing, the "ground truth" would be established by the physical and chemical properties of the materials, the design specifications, and the established physical and biological limits defined by regulatory standards (e.g., ISO, FDA guidance). It's based on engineering specifications and regulatory standards, not expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
Not applicable. There is no AI component or machine learning model for which a training set would be required.
9. How the ground truth for the training set was established
Not applicable. There is no AI component or machine learning model.
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Straumann® BLX Line Extension - New Abutments
510(k) Summary – K190040
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
Date of Submission: April 8, 2019
5.2 Name of the Device
| Trade Names: | Straumann® BLX Line Extension - New Abutments |
|---|---|
| Common Name: | Endosseous Dental Implant Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Classification: | Class II |
| Product Codes: | NHA |
Predicate Device(s) 5.3
Primary Predicate:
- . K173961 – Straumann BLX Implant System
Reference Devices:
- K173968 - Straumann Variobase for Bridge/Bar Cylindrical
- K173379 Straumann Variobase for Crown AS .
- . K173902 – Neodent Implant System - GM Line
- K172798 Straumann CARES Abutments CoCr ●
- K151157 Straumann Variobase Abutment for Bars/Bridges ●
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Straumann® BLX Line Extension - New Abutments
510(k) Summary - K190040
- K150899 Straumann® CARES Titanium Alloy (TAN) Abutment .
5.4 Indications for Use
Straumann BLX Healing Abutments for Bars and Bridges
Straumann 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 form, maintain and stabilize the soft tissue during the healing process.
Healing abutments should be used only with suitable implant connections.
Healing components have a maximum duration of usage of 6 months.
Straumann BLX Temporary Abutments for Bars and Bridges
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 Variobase Abutments for Bar and Bridges
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 (bridge or overdenture) can be cemented on the Straumann® Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.
Straumann BLX Variobase Abutments AS
The Straumann Variobase for Crown AS is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann Variobase for Crown AS are indicated for screw retained single tooth or cement-retained single tooth
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Straumann® BLX Line Extension - New Abutments
510(k) Summary - K190040
and bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. All digitally designed copings and/or crowns for use with the Straumann Variobase for Crown AS are intended to be sent to Straumann for manufacture at a validated milling center.
Straumann BLX Novaloc Abutments
The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants.
Straumann BLX CARES Abutments
The Straumann CARES Abutments are indicated for single tooth replacement and multiple tooth restorations.
The prosthetic restoration can be cemented or directly veneered/screw-retained.
5.5 Device Description
BLX Healing Abutments for Bars and Bridges
Healing abutments are screwed into the implant in cases of transmucosal healing to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. They are placed out of occlusion and have a maximum duration of usage of 180 days.
Unlike the predicate RB/WB healing abutments (K173961), the subject healing abutments are intended to shape the soft tissue for posterior placement of bridge restorations instead of single crowns. The subject healing abutments are manufactured from Titanium Grade 4 and are anodized in violet.
BLX Temporary Abutments for Bars and Bridges
Temporary Abutments are intended to be placed into Straumann dental implants to provide support for temporary restorations. 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, as well as provide a temporary esthetic solution. They support
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Straumann® BLX Line Extension – New Abutments
510(k) Summary - K190040
a temporary restoration and may not be placed into of occlusion. Straumann BLX Temporary Abutments have a maximum duration of usage of 180 days.
Unlike the predicate RB/WB temporary abutments (K173961), the subject temporary abutments are intended to shape the soft tissue for posterior placement of bridge restorations instead of sinqle crowns. The subject temporary abutment cannot be shortened. The Temporary abutment for bar/bridge is a non-engaging device intended to support multiple-unit restoration. The subject temporary abutment is manufactured from TAN and is anodized in violet.
The temporary abutments are fixed in the implant by means of a basal screw which is also manufactured from TAN.
BLX Variobase Abutments for Bars and Bridges
Variobase Abutments for Bars and Bridges are intended to be placed into Straumann implants to provide support for multi-unit restorations. The prosthetic restoration (bar/bridge) must be cemented onto the Variobase abutments, which is then screwed onto the implants. 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.
Unlike the predicate Variobase abutments (K173968), the subject Variobase abutments present 3 retention features in the chimney instead of 4. The Variobase abutments for bar/bridges are non-engaging devices intended to support multiple-unit restorations. The subject Variobase abutments are manufactured from TAN and are anodized in violet.
The Variobase abutments are fixed in the implant by means of a basal screw which is also manufactured from TAN.
BLX Variobase Abutments AS for Crowns
Variobase abutments AS for crowns are intended to be placed into Straumann implants to provide support for single-unit restorations. The prosthetic restoration (crown) must be cemented onto the Variobase abutment, which is then screwed onto the implant. A temporary restoration can be used prior to the insertion of the final components to
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Straumann® BLX Line Extension – New Abutments
510(k) Summary - K190040
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.
The Variobase abutments are manufactured from TAN and are anodized in violet or in brown according to the compatible BLX implant platform (RB/WB or RB).
Unlike the predicate Variobase abutments (K173961/K173379), the subject Variobase abutments present 3 retention features in the chimney instead of 4. The chimney presents a cutout window to facilitate the handling of the screw driver in an angulated position. The Variobase abutments AS for crown are engaging devices intended to support single-unit restorations. The Variobase abutments are fixed in the implant by means of a basal screw which is also manufactured from TAN.
The Variobase abutments for crown AS are titanium bases to be used as the lower part of two-piece abutments. The upper part of the two-piece abutment is a CAD/CAM designed and manufactured restoration. The planning and milling of the customized restoration must be made using the validated Straumann CARES Visual, Dental Wings software using the Straumann CARES Visual Plug-In. All digitally designed copings and/or crowns for use on the Variobase abutments are intended to be manufactured at a validated milling center.
BLX Novaloc Abutments
Novaloc Abutments are intended to be placed into Straumann dental implants to provide support for full arch detachable restorations (over-denture).
The Novaloc abutments are manufactured from TAV (Ti-6Al-4V, Titanium-Aluminum-Vanadium) and are anodized in violet. The restoration is connected to the Novaloc abutment through a snap-on fixture provided by a negative shape of Novaloc snap-on fixture embedded into the final restoration. The snap-on feature is TiN coated.
Unlike the reference Novaloc abutments (K173902), the subject Novaloc abutments are not only provided in a straight version but also angulated.
The Novaloc abutments are provided non-sterile with instructions for end user sterilization.
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Straumann® BLX Line Extension - New Abutments
510(k) Summary - K190040
Angled models: are composed of an abutment body with a coupled basal screw. They are engaging devices.
Straight models: both body and thread parts are machined in one piece. They are nonengaging devices.
BLX CARES Abutments
CARES Abutments are intended to be placed into Straumann implants to provide support for prosthetic reconstructions such as crowns and bridges. The final abutment, fabricated from a pre-milled blank, is designed to allow for individual customization regarding function and esthetics.
The blank, manufactured from TAN and CoCr, is composed of a pre-milled implant-toabutment connection (TorcFit) and a cylindrical body with enough material volume to create a wide range of geometries for the final abutment.
Inside the abutment, a screw channel provides access to the internal thread feature of the implant, such that the component can be firmly attached while providing fit between screw, abutment and implant.
The planning and milling of the customized restoration must be made using the validated Straumann CARES Visual, Dental Wings software using the Straumann CARES Visual Plug-In. The maximum angulation allowed is 30° and the minimum wall thickness allowed is 0.4 mm. All digitally designed abutments are intended to be manufactured at a validated milling center.
BLX Basal Screws
Basal screws are used to fix abutments to dental implant, and can also be used during lab procedures to fix lab prosthetic parts on implant analogs. They are provided along the abutments and also provided as standalone screws.
The subject Basal Screws are manufactured from TAN.
The Basal Screw for Variobase AS is anodized in green since this color identifies Straumann devices pertaining to AS system.
5.6 Technological Characteristics
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Straumann® BLX Line Extension – New Abutments
510(k) Summary – K190040
The technological characteristics of the subject devices are compared to the primary
predicate and reference devices in the following tables:
Healing Abutments for Bars and Bridges
| FEATURE | PROPOSED DEVICESubject Device | REFERENCE DEVICEK173961 |
|---|---|---|
| Indications for Use | Straumann 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 form, maintain and stabilize the soft tissue during the healing process. Healing abutments should be used only with suitable implant connections. Healing components have a maximum duration of usage of 6 months. | 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. |
| Material | Titanium Grade 4 | Titanium Grade 4 |
| Implant to Abutment Connection | BLX(with conical fitting) | BLX(with conical fitting) |
| Diameter | 4.5 and 5.5 mm | 4.0 to 7.5 mm |
| Gingival height | 1.5 mm | 1.5 to 3.5 mm |
| Abutment height | 2 to 4 mm | 2 to 4 mm |
| BLX Platform | RB/WB | RB/WBWB |
| Sterilization Method | Irradiation | Irradiation |
| Surface | Anodized | Anodized |
Table 1 – Comparison matrix: subject device versus reference device (Healing Abutments
for Bars and Bridges)
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Straumann® BLX Line Extension – New Abutments
510(k) Summary – K190040
Temporary Abutments for Bars and Bridges
| FEATURE | PROPOSED DEVICE | REFERENCE DEVICE | |
|---|---|---|---|
| Subject Device | K173961 | ||
| Indications forUse | Prosthetic components directly or indirectlyconnected to the endosseous dentalimplant are intended for use as an aid inprosthetic rehabilitations. Temporarycomponents can be used prior to theinsertion of the final components tomaintain, stabilize and shape the softtissue during the healing phase; they maynot be placed into occlusion. Finalabutments may be placed into occlusionwhen the implant is fully osseointegrated.BLX Temporary Abutments have amaximum duration of usage of 180 days. | Prosthetic components directly or indirectlyconnected to the endosseous dentalimplant are intended for use as an aid inprosthetic rehabilitations. Temporarycomponents can be used prior to theinsertion of the final components tomaintain, stabilize and shape the softtissue during the healing phase; they maynot be placed into occlusion. Finalabutments may be placed into occlusionwhen the implant is fully osseointegrated.BLX Temporary Abutments have amaximum duration of usage of 180 days. | |
| Material | Ti-6Al-7Nb | Ti-6Al-7Nb | |
| Implant toAbutmentConnection | TorcFit connection | TorcFit connection | |
| Diameter | 4.5 mm | 3.8, 4.5, 5.5 and 6 mm | |
| Gingivalheight | 1.5 mm | 0.75, 1.5, 2.5 and 3.5 mm | |
| Abutmentheight | 5.5 mm | 10 mm(can be shortened up to 6 mm) | |
| BLX Platform | RB/WB | RB/WBWB | |
| Angulation | Straight | Straight | |
| SterilizationMethod | Non-sterile/End user sterilized | Non-sterile/End user sterilized | |
| Surface | Partially anodized | Partially anodized | |
| PROPOSED DEVICE | REFERENCE DEVICE | ||
| FEATURE | Subject Device | K173968 | |
| Indications forUse | Straumann Variobase prosthetic componentsdirectly or indirectly connected to theendosseous dental implant are intended foruse as an aid in prosthetic rehabilitations. Theprosthetic restoration (bridge or overdenture)can be cemented on the Straumann®Variobase™ prosthetic components. Atemporary restoration can be used prior to theinsertion of the final components to maintain,stabilize and form the soft tissue during thehealing phase. They may not be placed intoocclusion. Final abutments and restorationsmay be placed into occlusion when the implantis fully osseointegrated. | Straumann Variobase for Bridge/Bar Cylindricalprosthetic components directly connected to theendosseous dental implants are indicated foruse as an aid in prosthetic rehabilitations. Thepatient-specific prosthetic restoration (bridge oroverdenture) can be cemented on theStraumann Variobase for Bridge/Bar Cylindricalprosthetic components. A temporary restorationcan be used prior to the insertion of the finalcomponents to maintain, stabilize and form thesoft tissue during the healing phase. They maynot be placed into occlusion. Straumann®Variobase for Bridge/Bar Cylindrical and patient-specific restorations may be placed intoocclusion when the implant is fullyosseointegrated. | |
| Material | Ti-6Al-7Nb | Ti-6Al-7Nb | |
| Implant toAbutmentConnection | TorcFit connection | CrossFit (NC) | |
| Diameter | 4.5 mm | 4.5 - 7.0 mm | |
| Abutmentheight | 3.5 mm | 3.5 – 4.5 mm | |
| Abutmentheight design | 3 retention features | 4 retention features | |
| Type ofrecommendedrestoration | Bars/Bridges | Bars/Bridges | |
| AbutmentAngulation | Straight | Straight | |
| DesignWorkflow | Wax-up orStraumann CARES Visual, Dental Wingssoftware using the Straumann CARESVisual Plug-In | Wax-up orStraumann CARES Visual, Dental Wingssoftware using the Straumann CARESVisual Plug-In | |
| ManufacturingWorkflow | Digital workflow via Straumann millingcenter | Digital workflow via Straumann millingcenter | |
| Coping/CrownMaterial | Materials cleared by the FDA under 21CFR 872.6660 or exempt materials asdescribed under 21 CFR 872.3060 (Noblemetal alloys) and 21 CFR 872.3710 (Basemetal alloys) | Materials cleared by the FDA under 21CFR 872.6660 or exempt materials asdescribed under 21 CFR 872.3060 (Noblemetal alloys) and 21 CFR 872.3710 (Basemetal alloys) | |
| Coping/CrownAngulation | Up to 30° | Up to 30° | |
| SterilizationMethod | Non-sterile/End user sterilized | Non-sterile/End user sterilized | |
| Surface | Partially anodized | Machined | |
| PROPOSED DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | |
| FEATURE | Subject Device | K173379 | K173961 |
| Indications forUse | The Straumann Variobasefor Crown AS is a titaniumbase placed ontoStraumann dental implantsto provide support forcustomized prostheticrestorations. StraumannVariobase for Crown ASare indicated for screwretained single tooth orcement-retained singletooth and bridgerestorations. A temporaryrestoration can be usedprior to the insertion of thefinal components tomaintain, stabilize and formthe soft tissue during thehealing phase. Temporaryrestorations are indicatedto be placed out ofocclusion. All digitallydesigned copings and/orcrowns for use with theStraumann Variobase forCrown AS are intended tobe sent to Straumann formanufacture at a validatedmilling center. | The Straumann Variobasefor Crown AS is a titaniumbase placed ontoStraumann dental implantsto provide support forcustomized prostheticrestorations. StraumannVariobase for Crown ASare indicated for screwretained single tooth orcement-retained singletooth and bridgerestorations. A temporaryrestoration can be usedprior to the insertion of thefinal components tomaintain, stabilize and formthe soft tissue during thehealing phase. Temporaryrestorations are indicatedto be placed out ofocclusion. All digitallydesigned copings and/orcrowns for use with theStraumann Variobase forCrown AS are intended tobe sent to Straumann formanufacture at a validatedmilling center. | Straumann Variobaseprosthetic componentsdirectly or indirectlyconnected to theendosseous dental implantare intended for use as anaid in prostheticrehabilitations. Theprosthetic restoration(crowns) can be cementedonto the StraumannVariobase prostheticcomponents. A temporaryrestoration can be usedprior to the insertion of thefinal components tomaintain, stabilize andshape the soft tissue duringthe healing phase. Theymay not be placed intoocclusion. Final abutmentsand restorations may beplaced into occlusion whenthe implant is fullyosseointegrated.. Alldigitally designed copingsand/or crowns for use withthe Straumann VariobaseAbutment system areintended to be sent toStraumann for manufactureat a validated millingcenter. |
| Material | Ti-6Al-7Nb | Ti-6Al-7Nb | Ti-6Al-7Nb |
| Implant toAbutmentConnection | TorcFit connection | NC/RC (CrossFit) | TorcFit connection |
| Diameter | 4.5 and 5.5 mm | 3.8 mm - 7.0 mm | 3.8 to 5.5 mm |
| Gingivalheight | 1.5 mm | 1.0 – 3.0 mm | 0.75 – 2.5 mm |
| Abutmentheight | 5.5 mm | 3.5 mm – 6.5 mm | 5.5 mm(can be reduced until 3.5mm) |
| Abutmentheight design | Cylindrical, with cutoutwindow | Cylindrical, with cutoutwindow | Cylindrical, without cutoutwindow |
| Type ofrecommendedrestoration | Crowns | Crowns | Crowns |
| PROPOSED DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | |
| FEATURE | Subject Device | K173379 | K173961 |
| DesignWorkflow | Wax-up orStraumann CARES Visual,Dental Wings softwareusing the StraumannCARES Visual Plug-In | Straumann CARES Visual | Wax-up orStraumann CARES Visual,Dental Wings softwareusing the StraumannCARES Visual Plug-In |
| ManufacturingWorkflow | Digital workflow viaStraumann milling center | Traditional casting orpressing or StraumannMilling | Digital workflow viaStraumann milling center |
| Coping/CrownMaterial | Zerion LT | Cast materials:- Type 4 metals (ISO22674)- Base metal alloys (e.g.,cobalt-chromium (CoCr))- Noble metal alloys (e.g.,gold alloy)Press materials:- IPS e.max® PressCeramicDigital materials:- coron®- zerion® LT- polycon® ae- zerion ML- zerion UTML- IPS e.max® CAD Ceramic- nlce | IPS e.max CADPolycon ae |
| AbutmentAngulation | Up to 30° | Up to 30° | Up to 30° |
| SterilizationMethod | Non-sterile/End user sterilized | Non-sterile/End user sterilized | Non-sterile/End user sterilized |
| Surface | Partially anodized | Machined | Partially anodized |
| FEATURE | PROPOSED DEVICE | REFERENCE DEVICE | REFERENCE DEVICE |
| Subject Device | K173902 | K173968 | |
| Indications forUse | The Straumann®Retentive System isindicated for theattachment of full orpartial dentures onStraumann dentalimplants. | The Neodent Implant Systemis intended to be surgicallyplaced in the bone of theupper or lower jaw to providesupport for prosthetic devicessuch as artificial teeth, torestore chewing function. Itmay be used with single-stage or two-stageprocedures, for single ormultiple unit restorations, andmay be loaded immediatelywhen good primary stability isachieved and with appropriateocclusal loading. | Straumann Variobase forBridge/Bar Cylindricalprostheticcomponents directlyconnected to the endosseousdental implants are indicatedfor use as an aid in prostheticrehabilitations. The patient-specific prosthetic restoration(bridge or overdenture)can be cemented on theStraumann Variobase forBridge/Bar Cylindricalprosthetic components. Atemporary restoration can beused prior to the insertion ofthe final components tomaintain, stabilize and formthe soft tissue during thehealing phase. They may notbe placed into occlusion.Straumann®Variobase for Bridge/BarCylindrical and patient-specificrestorations may be placedinto occlusion when theimplantis fully osseointegrated. |
| Material | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-7Nb |
| Implant toAbutmentConnection | TorcFit connection | Neodent GM connection | CrossFit (NC) |
| Diameter | 4.5 mm | 3.3 mm | 4.5 – 7.0 mm |
| Gingivalheight | 1.5 to 6.5 mm | 1.5 to 5.5 mm | NA |
| Abutment-to-restorationconnection | Snap on feature | Snap on feature | Cement-retained |
| Type ofrecommendedrestoration | Multi-unit | Multi-unit | Multi-unit |
| AbutmentAngulation | 0 and 15° | Straight | Straight |
| SterilizationMethod | Non-sterile/End user sterilized | Non-sterile/End user sterilized | Non-sterile/End user sterilized |
| Surface | Partially anodized /TiN coated | TiN coated | Machined |
| FEATURE | PROPOSED DEVICE | REFERENCE DEVICE | REFERENCE DEVICE |
| Subject Device | K172798 | K150899 | |
| Indications forUse | The Straumann CARESAbutments are indicated forsingle tooth replacementand multiple toothrestorations.The Straumann CARESTAN and CoCr abutmentrestoration can becemented or directlyveneered/screw-retained.The Straumann CARESGolden Ti/TiN abutmentrestoration is cement-retained. | The Straumann CARESAbutments CoCr areindicated for single toothreplacement and multipletooth restorations.The prosthetic restorationcan be cemented or directlyveneered/ screw-retained | The Straumann CARESTAN abutments areindicated for single toothreplacement and multipletooth restorations. Theprosthetic restoration canbe cemented or directlyveneered/ screw-retained. |
| Material | TANCoCr | CoCr | TAN |
| Implant toAbutmentConnection | TorcFit connection | CrossFit (NC/RC) | CrossFit (NC/RC) |
| Type ofrecommendedrestoration | Crowns and bridges | Crowns and bridges | Crowns and bridges |
| DesignWorkflow | Wax-up orStraumann CARES Visual,Dental Wings softwareusing the StraumannCARES Visual Plug-In | Wax-up orStraumann CARES Visual.Dental Wings softwareusing the StraumannCARES Visual Plug-In | Wax-up orStraumann CARES Visual,Dental Wings softwareusing the StraumannCARES Visual Plug-In |
| ManufacturingWorkflow | Digital workflow viaStraumann milling center | Digital workflow viaStraumann milling center | Digital workflow viaStraumann milling center |
| AbutmentAngulation | Up to 30° | Up to 30° | Up to 30° |
| SterilizationMethod | Non-sterile/End user sterilized | Non-sterile/End user sterilized | Non-sterile/End user sterilized |
| Surface finish | Partially anodized | Machined | Machined |
Table 2 – Comparison matrix: subject device versus reference device (Temporary
Abutments for Bars and Bridges)
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Straumann® BLX Line Extension – New Abutments
510(k) Summary – K190040
Variobase Abutments for Bars and Bridges
Table 3 – Comparison matrix: subject device versus reference device (Variobase
Abutments for Bars and Bridges)
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Straumann® BLX Line Extension – New Abutments
510(k) Summary – K190040
Variobase Abutments AS for Crowns
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Straumann® BLX Line Extension – New Abutments
510(k) Summary – K190040
Table 4 – Comparison matrix: subject device versus reference device (Variobase
Abutments AS for Crowns)
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Straumann® BLX Line Extension – New Abutments
510(k) Summary – K190040
Novaloc Abutments
Table 5 – Comparison matrix: subject device versus reference device (Novaloc Abutments)
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Straumann® BLX Line Extension – New Abutments
510(k) Summary – K190040
CARES Abutments
Table 6 – Comparison matrix: subject device versus reference device (CARES Abutments)
Performance Testing 5.7
The following performance data support the substantial equivalence determination.
5.7.1 Sterilization Validation and Shelf Life
The BLX Healing abutments are provided sterile via gamma irradiation at a dose of 25 kilogray (2.5 Mrad) minimum. A sterility assurance level (SAL) of 10-6 has 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
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Straumann® BLX Line Extension - New Abutments
510(k) Summary - K190040
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 Healing abutments 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 other subject 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.
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.
The subject devices have equivalent nature of body contact, contact duration, material formulation and sterilization methods compared to the primary and reference devices.
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Straumann® BLX Line Extension - New Abutments
510(k) Summary – K190040
Bench Testing 5.7.3
Dynamic fatigue and static strength tests 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. The test environment for the temporary abutments, Novaloc abutments, and CARES Abutments (TAN) was ambient air. The test environment for the remaining abutments was 0.9% NaCl at 37°.
5.7.4 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 subject Straumann BLX Abutments are substantially equivalent to the primary predicate and reference devices.
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Image /page/15/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 and 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.
April 8, 2019
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K190040
Trade/Device Name: Straumann® BLX Line Extension - New Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 7, 2019 Received: January 8, 2019
Dear Jennifer Jackson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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,
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
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Indications for Use
510(k) Number (if known)
Device Name
Straumann® BLX Line Extension - New Abutments
Indications for Use (Describe)
Straumann BLX Healing Abutments for Bars and Bridges
Straumann Healing abutments are indicated to be placed in the patient's mouth at the implant placement to protect the inner configuration of the implant and to form, maintain and stabilize the soft tissue during the healing process.
Healing abutments should be used only with suitable implant connections.
Healing components have a maximum duration of usage of 6 months.
Straumann BLX Temporary Abutments for Bar and Bridges
Prosthetic components directly 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 BLX Variobase Abutments for Bar and Bridges
Straumann® Variobase™ prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic restoration (bridge or overdenture) can be cemented on the Straumann® Variobase™ prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the healing phase. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.
Straumann BLX Variobase Abutments AS
The Straumann Variobase for Crown AS is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann Variobase for Crown AS are indicated for screw retained single tooth or cement-retained single tooth and bridge restoration can be used prior to the insertion of the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. All digitally designed copings and/or crowns for use with the Straumann Variobase for Crown AS are intended to be sent to Straumann for manufacture at a validated milling center.
Straumann BLX Novaloc Abutments
The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants.
Straumann BLX CARES Abutments
The Straumann CARES Abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.
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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)
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§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)