Straumann BLX Line Extension - New Abutments
Device Facts
| Record ID | K190040 |
|---|---|
| Device Name | Straumann BLX Line Extension - New Abutments |
| Applicant | Institut Straumann AG |
| Product Code | NHA · Dental |
| Decision Date | Apr 8, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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 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.
Device Story
System of endosseous dental implant abutments (healing, temporary, Variobase, Novaloc, CARES) used to support prosthetic restorations (crowns, bridges, dentures) on Straumann dental implants. Healing/temporary components protect implant connections and shape soft tissue during healing; final components provide structural support for restorations. Operated by dental professionals in clinical settings. Variobase and CARES abutments utilize CAD/CAM digital workflows (Straumann CARES Visual software) for customized restoration design, with manufacturing performed at validated milling centers. Novaloc abutments provide snap-on retention for overdentures. Output is a stable prosthetic restoration; clinical benefit is restoration of dental function and aesthetics. Device components are fixed to implants via basal screws.
Clinical Evidence
No clinical data submitted. Substantial equivalence supported by bench testing (dynamic fatigue and static strength) and biocompatibility evaluation.
Technological Characteristics
Materials: Titanium Grade 4, Ti-6Al-7Nb (TAN), Ti-6Al-4V (TAV), CoCr. Connection: TorcFit. Sterilization: Gamma irradiation (healing abutments) or end-user steam sterilization. Design: CAD/CAM digital workflow for customized components. Surface: Anodized or TiN coated.
Indications for Use
Indicated for patients requiring dental implant-supported prosthetic restorations, including healing, temporary, and final abutments for single-tooth, bridge, or full/partial denture attachments. Contraindicated for placement into occlusion during the healing phase (temporary components).
Regulatory Classification
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.
Special Controls
*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.)
Predicate Devices
- Straumann BLX Implant System (K173961)
Reference Devices
- Straumann Variobase for Bridge/Bar Cylindrical (K173968)
- Straumann Variobase for Crown AS (K173379)
- Neodent Implant System - GM Line (K173902)
- Straumann CARES Abutments CoCr (K172798)
- Straumann Variobase Abutment for Bars/Bridges (K151157)
- Straumann® CARES Titanium Alloy (TAN) Abutment (K150899)
Submission Summary (Full Text)
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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 DEVICE<br>Subject Device | REFERENCE DEVICE<br>K173961 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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<br>(with conical fitting) | BLX<br>(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/WB<br>WB |
| 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 for<br>Use | Prosthetic components directly or indirectly<br>connected to the endosseous dental<br>implant are intended for use as an aid in<br>prosthetic rehabilitations. Temporary<br>components can be used prior to the<br>insertion of the final components to<br>maintain, stabilize and shape the soft<br>tissue during the healing phase; they may<br>not be placed into occlusion. Final<br>abutments may be placed into occlusion<br>when the implant is fully osseointegrated.<br>BLX Temporary Abutments have a<br>maximum duration of usage of 180 days. | Prosthetic components directly or indirectly<br>connected to the endosseous dental<br>implant are intended for use as an aid in<br>prosthetic rehabilitations. Temporary<br>components can be used prior to the<br>insertion of the final components to<br>maintain, stabilize and shape the soft<br>tissue during the healing phase; they may<br>not be placed into occlusion. Final<br>abutments may be placed into occlusion<br>when the implant is fully osseointegrated.<br>BLX Temporary Abutments have a<br>maximum duration of usage of 180 days. | |
| Material | Ti-6Al-7Nb | Ti-6Al-7Nb | |
| Implant to<br>Abutment<br>Connection | TorcFit connection | TorcFit connection | |
| Diameter | 4.5 mm | 3.8, 4.5, 5.5 and 6 mm | |
| Gingival<br>height | 1.5 mm | 0.75, 1.5, 2.5 and 3.5 mm | |
| Abutment<br>height | 5.5 mm | 10 mm<br>(can be shortened up to 6 mm) | |
| BLX Platform | RB/WB | RB/WB<br>WB | |
| Angulation | Straight | Straight | |
| Sterilization<br>Method | Non-sterile/<br>End user sterilized | Non-sterile/<br>End user sterilized | |
| Surface | Partially anodized | Partially anodized | |
| | PROPOSED DEVICE | REFERENCE DEVICE | |
| FEATURE | Subject Device | K173968 | |
| Indications for<br>Use | Straumann Variobase prosthetic components<br>directly or indirectly connected to the<br>endosseous dental implant are intended for<br>use as an aid in prosthetic rehabilitations. The<br>prosthetic restoration (bridge or overdenture)<br>can be cemented on the Straumann®<br>Variobase™ prosthetic components. A<br>temporary restoration can be used prior to the<br>insertion of the final components to maintain,<br>stabilize and form the soft tissue during the<br>healing phase. They may not be placed into<br>occlusion. Final abutments and restorations<br>may be placed into occlusion when the implant<br>is fully osseointegrated. | Straumann Variobase for Bridge/Bar Cylindrical<br>prosthetic components directly connected to the<br>endosseous dental implants are indicated for<br>use as an aid in prosthetic rehabilitations. The<br>patient-specific prosthetic restoration (bridge or<br>overdenture) can be cemented on the<br>Straumann Variobase for Bridge/Bar Cylindrical<br>prosthetic components. A temporary restoration<br>can be used prior to the insertion of the final<br>components to maintain, stabilize and form the<br>soft tissue during the healing phase. They may<br>not be placed into occlusion. Straumann®<br>Variobase for Bridge/Bar Cylindrical and patient-<br>specific restorations may be placed into<br>occlusion when the implant is fully<br>osseointegrated. | |
| Material | Ti-6Al-7Nb | Ti-6Al-7Nb | |
| Implant to<br>Abutment<br>Connection | TorcFit connection | CrossFit (NC) | |
| Diameter | 4.5 mm | 4.5 - 7.0 mm | |
| Abutment<br>height | 3.5 mm | 3.5 – 4.5 mm | |
| Abutment<br>height design | 3 retention features | 4 retention features | |
| Type of<br>recommended<br>restoration | Bars/Bridges | Bars/Bridges | |
| Abutment<br>Angulation | Straight | Straight | |
| Design<br>Workflow | Wax-up or<br>Straumann CARES Visual, Dental Wings<br>software using the Straumann CARES<br>Visual Plug-In | Wax-up or<br>Straumann CARES Visual, Dental Wings<br>software using the Straumann CARES<br>Visual Plug-In…
