(90 days)
No
The document describes physical dental abutments and their intended use, materials, and manufacturing processes. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The "digitally designed" components refer to CAD/CAM processes, which are not inherently AI/ML.
No
The device is described as an aid in prosthetic rehabilitations, protecting and shaping soft tissue during the healing process, and providing support for prosthetic restorations. While it aids in healing and rehabilitation, it does not directly "treat" a disease or condition in the way a therapeutic device typically would. Its primary function is mechanical support and tissue management, not active treatment or mitigation of a disease.
No
Explanation: The provided text describes various dental abutments and screws intended for use in prosthetic rehabilitations to support restorations, protect implants, and manage soft tissue during healing. There is no mention of these devices being used to diagnose conditions or gather diagnostic information.
No
The device description clearly details physical components made of materials like Titanium Grade 4, TAN, TAV, and CoCr, which are implanted or connected to implants in the patient's mouth. While some components are designed using software (CAD/CAM), the device itself is a physical medical device, not software-only.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The descriptions clearly state that these devices are implanted into the patient's mouth to support dental prosthetics and aid in the healing process. They are physical components placed within the body, not used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory testing.
These devices fall under the category of dental implants and prosthetic components, which are medical devices but not IVDs.
N/A
Intended Use / 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."
Product codes
NHA
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
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."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dental implants
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data to support substantial equivalence:
- 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. Sterility assurance level (SAL) of 10-6 validated per ISO 11137-1:2006. Packaging equivalent to predicate and reference device, shelf life 5 years. Other subject abutments are provided non-sterile and need end-user moist heat (steam) sterilization per ISO 17665-1 and ISO 17665-2.
- Biocompatibility Testing: Performed per ISO 10993-1:2009 and FDA Guidance. Subject devices have equivalent nature of body contact, contact duration, material formulation, and sterilization methods compared to primary and reference devices.
- Bench Testing: Dynamic fatigue and static strength tests performed per "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments". Demonstrated equivalence of Straumann BLX Implant System to predicate and reference devices. Test environment for temporary abutments, Novaloc abutments, and CARES Abutments (TAN) was ambient air. For remaining abutments, 0.9% NaCl at 37°.
- Clinical data: No device specific clinical data submitted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K173968, K173379, K173902, K172798, K151157, K150899
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.)
0
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
2
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
3
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.
5
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
6
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
Subject Device | REFERENCE DEVICE
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
(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/WB
WB |
| Sterilization Method | Irradiation | Irradiation |
| Surface | Anodized | Anodized |
Table 1 – Comparison matrix: subject device versus reference device (Healing Abutments
for Bars and Bridges)
7
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 | |||
| Use | 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. | 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. | |||
| Material | Ti-6Al-7Nb | Ti-6Al-7Nb | |
| Implant to | |||
| Abutment | |||
| Connection | TorcFit connection | TorcFit connection | |
| Diameter | 4.5 mm | 3.8, 4.5, 5.5 and 6 mm | |
| Gingival | |||
| height | 1.5 mm | 0.75, 1.5, 2.5 and 3.5 mm | |
| Abutment | |||
| height | 5.5 mm | 10 mm | |
| (can be shortened up to 6 mm) | |||
| BLX Platform | RB/WB | RB/WB | |
| WB | |||
| Angulation | Straight | Straight | |
| Sterilization | |||
| Method | Non-sterile/ | ||
| End user sterilized | Non-sterile/ | ||
| End user sterilized | |||
| Surface | Partially anodized | Partially anodized | |
| PROPOSED DEVICE | REFERENCE DEVICE | ||
| FEATURE | Subject Device | K173968 | |
| Indications for | |||
| Use | 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 Variobase for Bridge/Bar Cylindrical | ||
| prosthetic components directly connected to the | |||
| endosseous dental implants are indicated for | |||
| use as an aid in prosthetic rehabilitations. The | |||
| patient-specific prosthetic restoration (bridge or | |||
| overdenture) can be cemented on the | |||
| Straumann Variobase for Bridge/Bar Cylindrical | |||
| 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. Straumann® | |||
| Variobase for Bridge/Bar Cylindrical and patient- | |||
| specific restorations may be placed into | |||
| occlusion when the implant is fully | |||
| osseointegrated. | |||
| Material | Ti-6Al-7Nb | Ti-6Al-7Nb | |
| Implant to | |||
| Abutment | |||
| Connection | TorcFit connection | CrossFit (NC) | |
| Diameter | 4.5 mm | 4.5 - 7.0 mm | |
| Abutment | |||
| height | 3.5 mm | 3.5 – 4.5 mm | |
| Abutment | |||
| height design | 3 retention features | 4 retention features | |
| Type of | |||
| recommended | |||
| restoration | Bars/Bridges | Bars/Bridges | |
| Abutment | |||
| Angulation | Straight | Straight | |
| Design | |||
| Workflow | Wax-up or | ||
| Straumann CARES Visual, Dental Wings | |||
| software using the Straumann CARES | |||
| Visual Plug-In | Wax-up or | ||
| Straumann CARES Visual, Dental Wings | |||
| software using the Straumann CARES | |||
| Visual Plug-In | |||
| Manufacturing | |||
| Workflow | Digital workflow via Straumann milling | ||
| center | Digital workflow via Straumann milling | ||
| center | |||
| Coping/ | |||
| Crown | |||
| Material | Materials cleared by the FDA under 21 | ||
| CFR 872.6660 or exempt materials as | |||
| described under 21 CFR 872.3060 (Noble | |||
| metal alloys) and 21 CFR 872.3710 (Base | |||
| metal alloys) | Materials cleared by the FDA under 21 | ||
| CFR 872.6660 or exempt materials as | |||
| described under 21 CFR 872.3060 (Noble | |||
| metal alloys) and 21 CFR 872.3710 (Base | |||
| metal alloys) | |||
| Coping/ | |||
| Crown | |||
| Angulation | Up to 30° | Up to 30° | |
| Sterilization | |||
| Method | 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 for | |||
| Use | 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. | 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 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 | |||
| may not be placed into | |||
| 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. | |||
| Material | Ti-6Al-7Nb | Ti-6Al-7Nb | Ti-6Al-7Nb |
| Implant to | |||
| Abutment | |||
| Connection | 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 |
| Gingival | |||
| height | 1.5 mm | 1.0 – 3.0 mm | 0.75 – 2.5 mm |
| Abutment | |||
| height | 5.5 mm | 3.5 mm – 6.5 mm | 5.5 mm |
| (can be reduced until 3.5 | |||
| mm) | |||
| Abutment | |||
| height design | Cylindrical, with cutout | ||
| window | Cylindrical, with cutout | ||
| window | Cylindrical, without cutout | ||
| window | |||
| Type of | |||
| recommended | |||
| restoration | Crowns | Crowns | Crowns |
| PROPOSED DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | |
| FEATURE | Subject Device | K173379 | K173961 |
| Design | |||
| Workflow | Wax-up or | ||
| Straumann CARES Visual, | |||
| Dental Wings software | |||
| using the Straumann | |||
| CARES Visual Plug-In | Straumann CARES Visual | Wax-up or | |
| Straumann CARES Visual, | |||
| Dental Wings software | |||
| using the Straumann | |||
| CARES Visual Plug-In | |||
| Manufacturing | |||
| Workflow | Digital workflow via | ||
| Straumann milling center | Traditional casting or | ||
| pressing or Straumann | |||
| Milling | Digital workflow via | ||
| Straumann milling center | |||
| Coping/ | |||
| Crown | |||
| Material | Zerion LT | Cast materials: |
- Type 4 metals (ISO
- Base metal alloys (e.g.,
cobalt-chromium (CoCr)) - Noble metal alloys (e.g.,
gold alloy)
Press materials: - IPS e.max® Press
Ceramic
Digital materials: - coron®
- zerion® LT
- polycon® ae
- zerion ML
- zerion UTML
- IPS e.max® CAD Ceramic
- nlce | IPS e.max CAD
Polycon ae |
| Abutment
Angulation | Up to 30° | Up to 30° | Up to 30° |
| Sterilization
Method | 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 for
Use | The Straumann®
Retentive System is
indicated for the
attachment of full or
partial dentures on
Straumann dental
implants. | The Neodent Implant System
is intended to be surgically
placed in the bone of the
upper or lower jaw to provide
support for prosthetic devices
such as artificial teeth, to
restore chewing function. It
may be used with single-
stage or two-stage
procedures, for single or
multiple unit restorations, and
may be loaded immediately
when good primary stability is
achieved and with appropriate
occlusal loading. | Straumann Variobase for
Bridge/Bar Cylindrical
prosthetic
components directly
connected to the endosseous
dental implants are indicated
for use as an aid in prosthetic
rehabilitations. The patient-
specific prosthetic restoration
(bridge or overdenture)
can be cemented on the
Straumann Variobase for
Bridge/Bar Cylindrical
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.
Straumann®
Variobase for Bridge/Bar
Cylindrical and patient-specific
restorations may be placed
into occlusion when the
implant
is fully osseointegrated. |
| Material | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-7Nb |
| Implant to
Abutment
Connection | TorcFit connection | Neodent GM connection | CrossFit (NC) |
| Diameter | 4.5 mm | 3.3 mm | 4.5 – 7.0 mm |
| Gingival
height | 1.5 to 6.5 mm | 1.5 to 5.5 mm | NA |
| Abutment-to-
restoration
connection | Snap on feature | Snap on feature | Cement-retained |
| Type of
recommended
restoration | Multi-unit | Multi-unit | Multi-unit |
| Abutment
Angulation | 0 and 15° | Straight | Straight |
| Sterilization
Method | 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 for
Use | The Straumann CARES
Abutments are indicated for
single tooth replacement
and multiple tooth
restorations.
The Straumann CARES
TAN and CoCr abutment
restoration can be
cemented or directly
veneered/screw-retained.
The Straumann CARES
Golden Ti/TiN abutment
restoration is cement-
retained. | The Straumann CARES
Abutments CoCr are
indicated for single tooth
replacement and multiple
tooth restorations.
The prosthetic restoration
can be cemented or directly
veneered/ screw-retained | The Straumann CARES
TAN abutments are
indicated for single tooth
replacement and multiple
tooth restorations. The
prosthetic restoration can
be cemented or directly
veneered/ screw-retained. |
| Material | TAN
CoCr | CoCr | TAN |
| Implant to
Abutment
Connection | TorcFit connection | CrossFit (NC/RC) | CrossFit (NC/RC) |
| Type of
recommended
restoration | Crowns and bridges | Crowns and bridges | Crowns and bridges |
| Design
Workflow | Wax-up or
Straumann CARES Visual,
Dental Wings software
using the Straumann
CARES Visual Plug-In | Wax-up or
Straumann CARES Visual.
Dental Wings software
using the Straumann
CARES Visual Plug-In | Wax-up or
Straumann CARES Visual,
Dental Wings software
using the Straumann
CARES Visual Plug-In |
| Manufacturing
Workflow | Digital workflow via
Straumann milling center | Digital workflow via
Straumann milling center | Digital workflow via
Straumann milling center |
| Abutment
Angulation | Up to 30° | Up to 30° | Up to 30° |
| Sterilization
Method | 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)
8
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)
9
Straumann® BLX Line Extension – New Abutments
510(k) Summary – K190040
Variobase Abutments AS for Crowns
10
Straumann® BLX Line Extension – New Abutments
510(k) Summary – K190040
Table 4 – Comparison matrix: subject device versus reference device (Variobase
Abutments AS for Crowns)
11
Straumann® BLX Line Extension – New Abutments
510(k) Summary – K190040
Novaloc Abutments
Table 5 – Comparison matrix: subject device versus reference device (Novaloc Abutments)
12
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
13
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.
14
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.
15
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.
16
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
17
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.
18
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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