(159 days)
K122855 TL 04.1mm RN,S, SLAcitve TiZr 6, 8, 10, 12, 14, 16mm Dental . Implants, K033922 Device Modification ITI® Dental Implants ., K162890 - BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment., K101545 Genesis Implant System ●, K153624 Neodent Implant System ., K170838 Medentika TiBases ., K130808 Straumann Healing Abutments, Healing Caps, and Closure Screws ●, K092814 Straumann NC Temporary Abutments ., K120822 Straumann® CARES® Variobase™ Abutments ., K170354 Straumann Variobase Abutments ●, K142890 Straumann Variobase Abutment NNC, Straumann Variobase . Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit
No
The document describes dental implants and associated components, with no mention of AI or ML technology in the intended use, device description, or performance studies. The software mentioned is for digital workflow and modeling, not AI/ML.
No
The device is described as an aid in prosthetic rehabilitations to restore chewing function and for aesthetic oral rehabilitation, not primarily for treating a disease or disorder.
No
The described Straumann® BLX Implants and associated components are intended for dental implantation and prosthetic rehabilitation, not for diagnosing medical conditions.
No
The device description clearly details physical components such as implants, closure caps, healing abutments, temporary abutments, Variobase abutments, and basal screws, all made from materials like Roxolid, Titanium, and TAN. While software is mentioned for verification and validation in the context of a digital workflow for prosthetic components, the core device is a system of physical implants and related hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for endosteal implantation in the jaw for oral rehabilitation and restoration of chewing function. This involves surgical placement and mechanical support for prosthetic restorations.
- Device Description: The device components are described as implants, closure caps, healing abutments, temporary abutments, Variobase abutments, and basal screws. These are all physical components designed for surgical implantation and prosthetic attachment within the body.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease or impairment. IVDs are typically used to analyze blood, urine, tissue, or other bodily fluids or samples.
The device described is a dental implant system, which is a type of medical device used for surgical and prosthetic purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Straumann® BLX Implants
Straumann® BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX Implants can be placed with immediate function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components.
Straumann® BLX Closure Caps and Healing Abutments
Straumann® Closure Caps and Healing Abutments are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and to shape, maintain and stabilize the soft tissue during the healing process. Closure caps and healing abutments should be used only with suitable implant connections. Straumann Closure Caps and Healing Abutments have a maximum duration of usage of 6 months.
Straumann® BLX Basal Screws and Temporary Abutments
Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. Final abutments may be placed into occlusion when the implant is fully osseointegrated.
BLX Temporary Abutments have a maximum duration of usage of 180 days.
Straumann® BLX Variobases
Straumann® Variobase® prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (crowns) can be cemented onto the Straumann® Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
Product codes
DZE, NHA
Device Description
The Straumann BLX Implants are fully tapered implants manufactured utilizing the Roxolid material and are finished with SLActive® surface. The connection is identified as conical fitting with Torx style engaging feature. The prosthetic platforms are identified as RB (Regular Base) and WB (Wide Base). The implants with a RB platform have a "small top/head", and implants with WB platform have a "large top/head", whereas the internal connection is identical for both platform and all the implant diameters and lengths. They are available in the following sizes: RB platform with neck Ø 3.5 mm, maximum outer Ø 4.5 mm, and lengths from 6 to 18 mm; WB platform with neck Ø 4.5 mm, maximum outer Ø 5.5 mm, and lengths from 6 to 12 mm.
The closure cap and healing abutments are manufactured from Titanium Grade 4, per ISO 5832-2 and ISO 5832-11, and are anodized signal violet for RB platform compatible parts and brown for WB platform compatible parts for identification. Closure caps are screwed into the implant to protect the inner configuration and shoulder of the implant during submerged healing. Healing abutments are screwed into the implant to protect the inner configuration in cases of transmucosal healing and are placed out of occlusion.
Closure Caps are available for RB/WB platforms with gingival height 0.4 mm and for WB platform with gingival height 0.5 mm.
Healing Abutments are available for RB/WB platforms with Ø 4.0 mm, gingival heights 1.5, 2.5 mm, and abutment heights 2, 4 mm; for RB/WB platforms with Ø 5.0 mm, gingival heights 1.5, 2.5 mm, and abutment heights 2, 4 mm; for WB platform with Ø 6.0 mm, gingival heights 0.75, 1.5 mm, and abutment heights 2, 4 mm; for RB/WB platforms with Ø 6.5 mm, gingival heights 1.5, 2.5, 3.5 mm, and abutment heights 2, 4 mm; for WB platform with Ø 7.5 mm, gingival heights 0.75, 1.5 mm, and abutment heights 2, 4 mm.
The temporary abutments are manufactured from TAN and are anodized signal violet (RB platform) and brown (WB platform) for identification. They are fixed in the implant with a basal screw, also manufactured from TAN, which is delivered with the temporary abutment. Sizes are: RB/WB with Ø 3.8 mm, gingival heights 1.5, 2.5 mm; RB/WB with Ø 4.5 mm, gingival heights 1.5, 2.5 mm; RB/WB with Ø 6.0 mm, gingival heights 2.5, 3.5 mm, chimney height 10 mm; WB with Ø 5.5 mm, gingival heights 0.75, 1.5 mm.
BLX Variobase abutments is a two-piece abutment ultimately composed by three components: Variobase™ Abutment (Ti-base), Prosthetic restoration (coping and/or crown), and Basal Screw. The BLX Variobase Abutments are manufactured along with the corresponding basal screw. The prosthetic restoration (crowns) can be cemented onto the Variobase prosthetic components. They are available in the following sizes: RB/WB with Ø 3.8 mm, gingival heights 1.5, 2.5 mm; RB/WB with Ø 4.5 mm, gingival heights 1.5, 2.5 mm, chimney height 5.5 mm; WB with Ø 5.5 mm, gingival heights 0.75, 1.5 mm.
The BLX Variobase Abutments will be marketed as a stand-alone component or through the CARES® X-Stream™ workflow. All digitally designed copings and/or crowns for use with the BLX Variobase Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
Prosthetic Restoration Design and Materials include Digital materials: IPS e.max CAD MO, LT or HT and polycon® ae (for temporary restorations). Manufacturing should follow material manufacturer's instructions. Recommended minimum wall thickness is 0.7 for IPS e.max CAD and 0.5 for polycon® ae. Minimum angulation is 0° and maximum angulation is 30° for both.
Basal screws are used to seat the temporary abutments and the BLX Variobase Abutments to the dental implant, and can be also be used during lab procedures to fix lab prosthetic parts on implant analogs. There is one basal screw for the RB platform and one for the WB platform. They have identical designs and differ only in color-coding (signal violet and brown) to ease the handling. They are provided along the abutments but they are also provided as standalone screws. The BLX basal screws are manufactured from TAN.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower jaw
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)
- Sterilization Validation and Shelf Life: The BLX implants, closure caps, and healing abutments are provided sterile via gamma irradiation at a minimum dose of 25 kilogray (2.5 Mrad). Sterility assurance level (SAL) of 10^-6 validated per ISO 11137-1:2006 and ISO 11137-2:2013 (over kill bioburden method). BLX Temporary Abutments and BLX Variobase Abutments require end-user moist heat (steam) sterilization, validated according to ISO 17665-1, ISO 17665-2, and FDA guidance "Reprocessing Medical Devices in Health Care Settings". Shelf life for sterile devices is 5 years. Pyrogenicity testing meets specifications via LAL Endotoxin Analysis with a limit of 20 EU/device.
- Biocompatibility Testing: Performed according to ISO 10993-1:2009 and FDA Guidance "Use of International Standard ISO 10993-1". Subject devices have equivalent body contact, duration, material formulation, and sterilization methods compared to predicate devices. Differences in manufacturing assessed via Chemical Characterization and Cytotoxicity tests.
- Bench Testing:
- Dynamic fatigue and static strength tests: Performed according to FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments". Tested both RB and WB platforms, and proved equivalent to reference devices.
- Insertion torque tests: Conducted on worst-case defined diameters (Ø4.5, Ø 5.5, Ø 6.5 mm) of the BLX portfolio, for shortest (6 mm), middle (12 mm), and longest (18 mm) implants. Demonstrated that BLX Implants and related cutting instruments allow reaching suitable implant insertion torques.
- Pullout strength tests, surface area analysis, and bone-to-implant contact analysis: Performed for 6mm long BLX implants with Ø 4.5, 5.5, and 6.5 mm. Equivalency to reference devices was demonstrated.
- Software Verification and Validation Testing: Conducted and documented according to FDA guidance documents "Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations" and "General Principles of Software Validation; Final Guidance for Industry and FDA Staff". Software was considered a "moderate" level of concern. Software implementation verification demonstrated that all subject Variobase devices plus modeling components within the new BLX portfolio can work together in the defined digital workflow to produce properly fitting copings or crowns for the final two-piece abutment.
- Clinical data: No device specific clinical data has been submitted to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K150182 Neodent Implant System CM Drive Implants
Reference Device(s)
K122855 TL 04.1mm RN,S, SLAcitve TiZr 6, 8, 10, 12, 14, 16mm Dental . Implants, K033922 Device Modification ITI® Dental Implants ., K162890 - BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment., K101545 Genesis Implant System ●, K153624 Neodent Implant System ., K170838 Medentika TiBases ., K130808 Straumann Healing Abutments, Healing Caps, and Closure Screws ●, K092814 Straumann NC Temporary Abutments ., K120822 Straumann® CARES® Variobase™ Abutments ., K170354 Straumann Variobase Abutments ●, K142890 Straumann Variobase Abutment NNC, Straumann Variobase . Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810 June 5, 2018
Re: K173961
Trade/Device Name: Straumann® BLX Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 30, 2018 Received: May 1, 2018
Dear Jennifer Jackson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
forTina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Straumann® BLX Implant System
Indications for Use (Describe)
Straumann® BLX Implants
Straumann® BLX Implants are suitable for endosteal implantation in the upper and for the functional and esthetic oral rehabilitation of edentulous patients. BLX Implants can be placed with immediate function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components.
Straumann® BLX Closure Caps and Healing Abutments
Straumann® Closure Caps and Healing Abutments are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and to shape, maintain and stabilize the soft tissue during the healing process. Closure caps and healing abutments should be used only with suitable implant connections. Straumann Closure Caps and Healing Abuttnents have a maximum duration of usage of 6 months.
Straumann® BLX Basal Screws and Temporary Abutments
Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. Final abutnents may be placed into occlusion when the implant is fully osseointegrated. BLX Temporary Abutments have a maximum duration of usage of 180 days.
Straumann® BLX Variobases
Straumann® Variobase® prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (crowns) can be cemented onto the Straumann® Variobase® prosthetic components. A temporary restoration can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase; they must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
Straumann® BLX Implant System
510(k) Summary
510(k) Summary 5
Submitter's Contact Information 5.1
Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
| Phone Number: | 1-978-747-2509 |
|---|---|
| --------------- | ---------------- |
Fax Number: 1-978-747-0023
Contact Person: Jennifer M. Jackson, MS
| Prepared by: | Ana Carolina Martins Vianna |
|---|---|
| -------------- | ----------------------------- |
Viviana Horhoiu
Date of Submission: June 5, 2018
Name of the Device 5.2
| Trade Names: | Straumann® BLX Implant System |
|---|---|
| Common Name: | Endosseous Dental Implant |
| Classification Name: | Endosseous Dental Implant |
| Regulation Number: | 21 CFR 872.3640 |
| Classification: | Class II |
| Product Codes: | Primary product code: DZE |
| Secondary product code: NHA |
5.3 Predicate Device(s)
Primary Predicate:
-
K150182 Neodent Implant System CM Drive Implants .
Reference Devices: -
K122855 TL 04.1mm RN,S, SLAcitve TiZr 6, 8, 10, 12, 14, 16mm Dental . Implants
-
K033922 Device Modification ITI® Dental Implants .
5
Straumann® BLX Implant System
510(k) Summary
- . K162890 - BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment.
- K101545 Genesis Implant System ●
- K153624 Neodent Implant System .
- K170838 Medentika TiBases .
- K130808 Straumann Healing Abutments, Healing Caps, and Closure Screws ●
- K092814 Straumann NC Temporary Abutments .
- K120822 Straumann® CARES® Variobase™ Abutments .
- K170354 Straumann Variobase Abutments ●
- K142890 Straumann Variobase Abutment NNC, Straumann Variobase . Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit
5.4 Device Description
The Straumann BLX Implants are fully tapered implants manufactured utilizing the Roxolid material and are finished with SLActive® surface. The connection is identified as conical fitting with Torx style engaging feature. The prosthetic platforms are identified as RB (Regular Base) and WB (Wide Base). The implants with a RB platform have a "small top/head", and implants with WB platform have a "large top/head", whereas the internal connection is identical for both platform and all the implant diameters and lengths. They are available in the following sizes:
| Platform | Neck Ø
(mm) | Maximum outer Ø
(mm) | Length
(mm) |
|----------|----------------|-------------------------|----------------|
| RB | 3.5 | 4.5 | 6 |
| | | | 8 |
| | | | 10 |
| | | | 12 |
| | | | 14 |
| | | | 16 |
| | | | 18 |
| WB | 4.5 | 5.5 | 6 |
| | | | 8 |
6
Straumann® BLX Implant System
510(k) Summary
Image /page/6/Figure/3 description: The image shows a table with several numerical values. The values on the right side of the table are 10, 12, 6, 8, 10, and 12. There is also a value of 6.5 in the middle of the table. The table is divided into several cells by horizontal and vertical lines.
The closure cap and healing abutments are manufactured from Titanium Grade 4, per ISO 5832-2 and ISO 5832-11, and are anodized signal violet for the parts compatible with the RB platform and brown for the parts compatible with the WB platform for identification purposes. Closure caps are screwed into the implant to protect the inner configuration and shoulder of the implant during the healing phase in cases of submerged (submucosal) healing. Healing abutments are screwed into the implant to protect the inner configuration in cases of transmucosal healing and are placed out of occlusion. They are available in the following sizes:
Closure Caps:
| Platform | Gingival
heights
(mm) |
|----------|-----------------------------|
| RB/WB | 0.4 |
| WB | 0.5 |
Healing Abutments:
| Platform | Ø
(mm) | Gingival
heights
(mm) | Abutment
heights
(mm) |
|----------|-----------|-----------------------------|-----------------------------|
| RB/WB | 4.0 | 1.5 | 2 |
| | | | 4 |
| | | 2.5 | 2 |
| | | | 4 |
| RB/WB | 5.0 | 1.5 | 2 |
| | | | |
| | | 2.5 | 2 |
| | | | 4 |
| WB | 6.0 | 0.75 | 2 |
| | | | |
| | | 1.5 | 2 |
| | | | 4 |
7
Straumann® BLX Implant System
| Platform | Ø (mm) | Gingival
heights
(mm) | Abutment
heights
(mm) |
|----------|--------|-----------------------------|-----------------------------|
| RB/WB | 6.5 | 1.5 | 2 |
| | | | 4 |
| | | 2.5 | 2 |
| | | | 4 |
| | | 3.5 | 2 |
| | | | 4 |
| WB | 7.5 | 0.75 | 2 |
| | | | 4 |
| | | 1.5 | 2 |
| | | | 4 |
510(k) Summary
The temporary abutments are manufactured from TAN and are anodized signal violet (RB platform) and brown (WB platform) for identification purposes. The temporary abutments are fixed in the implant with a basal screw which is also manufactured from TAN. The basal screw will be delivered with the temporary abutment. They are available in the following sizes:
| Platform | Ø (mm) | Gingival heights (mm) | Chimney height (mm) |
|---|---|---|---|
| RB/WB | 3.8 | 1.5 | |
| 2.5 | |||
| RB/WB | 4.5 | 1.5 | |
| 2.5 | |||
| RB/WB | 6.0 | 2.5 | 10 |
| 3.5 | |||
| WB | 5.5 | 0.75 | |
| 1.5 |
BLX Variobase abutments is a two-piece abutment ultimately composed by three components:
- Variobase™ Abutment (Ti-base) .
- Prosthetic restoration (coping and/or crown) .
- Basal Screw ●
8
Straumann® BLX Implant System
510(k) Summary
The BLX Variobase Abutments are manufactured and are delivered with the corresponding basal screw. The prosthetic restoration (crowns) can be cemented onto the Variobase prosthetic components. They are available in the following sizes:
| Platform | Ø (mm) | Gingival heights (mm) | Chimney height (mm) |
|---|---|---|---|
| RB/WB | 3.8 | 1.5 | |
| 2.5 | |||
| RB/WB | 4.5 | 1.5 | 5.5 |
| 2.5 | |||
| WB | 5.5 | 0.75 | |
| 1.5 |
The BLX Variobase Abutments will be marketed as a stand-alone component or through the CARES® X-Stream™ workflow (prosthetic restoration designed and manufactured through CARES® Visual/validated Straumann milling and then shipped together with the Straumann® BLX Variobase® Abutment and basal screw in the same shipment). All digitally designed copings and/or crowns for use with the BLX Variobase Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
Prosthetic Restoration Design and Materials
- . Digital materials:
- o IPS e.max CAD MO, LT or HT
- o polycon® ae (for temporary restorations)
The manufacturing of the coping and/or crown should follow the standard procedure according to the material manufacturer's instructions for use.
For digital materials, the following range of modifications is recommended:
| IPS e.max | polycon® | |
|---|---|---|
| CAD | ae | |
| Minimum Wall Thickness | 0.7 | 0.5 |
| Minimum angulation | 0° | 0° |
| Maximum angulation | 30° | 30° |
9
Straumann® BLX Implant System
510(k) Summary
Basal screws are used to seat the temporary abutments and the BLX Variobase Abutments to the dental implant, and can be also be used during lab procedures to fix lab prosthetic parts on implant analogs. There is one basal screw for the RB platform and one for the WB platform. They have identical designs and differ only in color-coding (signal violet and brown) to ease the handling. They are provided along the abutments but they are also provided as standalone screws. The BLX basal screws are manufactured from TAN.
5.5 Indications for Use
Straumann® BLX Implants
Straumann® BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX Implants can be placed with immediate function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components.
Straumann® BLX Closure Caps and Healing Abutments
Straumann® Closure Caps and Healing Abutments are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and to shape, maintain and stabilize the soft tissue during the healing process. Closure caps and healing abutments should be used only with suitable implant connections. Straumann Closure Caps and Healing Abutments have a maximum duration of usage of 6 months.
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Straumann® BLX Implant System
510(k) Summary
Straumann® BLX Basal Screws and Temporary Abutments
Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. Final abutments may be placed into occlusion when the implant is fully osseointegrated.
BLX Temporary Abutments have a maximum duration of usage of 180 days.
Straumann® BLX Variobases
Straumann® Variobase® prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (crowns) can be cemented onto the Straumann® Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
5.6 Technological Characteristics
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following tables:
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Straumann® BLX Implant System
510(k) Summary
| | PROPOSED DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE PREDICATE DEVICES | | EQUIVALENCE |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FEATURE | Subject Device - BLX
Implants | K150182
Neodent Implant System | K122855
Straumann Implant System | K101545
Genesis Implant System | DISCUSSION |
| Indications
for Use | Straumann® BLX Implants
are suitable for endosteal
implantation in the upper
and lower jaw and for the
functional and esthetic oral
rehabilitation of edentulous
and partially edentulous
patients. BLX Implants can
be placed with immediate
function on single-tooth
applications when good
primary stability is achieved
and with appropriate
occlusal loading to restore
chewing function. The
prosthetic restorations are
connected to the implants
through the corresponding
abutment components. | 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® dental implants are
suitable for the treatment of oral
endosteal implantation in the upper
and lower jaw and for the
functional and esthetic oral
rehabilitation of edentulous and
partially dentate patients (unless
specific indications and limitations
are present, as stated below).
Straumann® dental Implants can
also be used for Immediate or
early, Implantation following
extraction or loss of natural teeth.
Implants can be placed with
immediate function on single-tooth
and/or multiple tooth applications
when good primary stability is
achieved and with appropriate
occlusal loading, to restore
chewing function. The prosthetic
restorations used are single
crowns, bridges and partial or full
dentures, which are connected to
the Implants by the corresponding
elements (abutments). When
placing implants in the posterior
region, we recommend using only
large diameter implants. In cases
of fully edentulous patients, 4 or
more implants must be used in
immediately loaded cases. | The Genesis Implant System
is intended for use in single-
stage or two-stage surgical
procedures in all types of
bone in partially or fully
edentulous mandibles and
maxillae. The Genesis Implant
System supports single or
multiple-unit restorations to re-
establish patient chewing
function and esthetics.
Genesis implants are intended
for placement following
natural tooth loss or for
immediate placement into an
extraction socket. Immediate
function may be achieved
when good primary stability is
established and appropriate
occlusal loading is applied. | The subject implants
have the same
indication as the primary
predicate device
K150182. Only minor
differenes in wording
that do not affect the
intended use. |
| Material | Titanium-13 Zirconium
alloy (Roxolid®) | Ti Grade 4 | Titanium-13 Zirconium alloy
(Roxolid®) | Ti Grade 4 | Identical to reference
device K122855. |
| | PROPOSED DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE PREDICATE DEVICES | | EQUIVALENCE
DISCUSSION |
| FEATURE | Subject Device – BLX | K150182 | K122855 | K101545 | |
| | Implants | Neodent Implant System | Straumann Implant System | Genesis Implant System | |
| Surface
Treatment | Hydrophilic SLActive® | Neoporos and
Acqua (hydrophilic) | Hydrophilic SLActive® | Hydrophilic surface enriched
with calcium and
phosphorous ions | Identical to the
primary prediate. |
| Implant to
Abutment
Connection | BLX
(with conical fitting) | CM
(with conical fitting) | Synocta
(with conical fitting) | TiLobe™ | The subject devices
have a conical implant-
to-abutment fitting as
well as K150182 and
K122855 devices,
nevertheless, each
implant system has its
own engaging feature
in the conical
connection. |
| Implant
Diameter | Ø 4.5, 5.5, 6.5 mm | Ø 3.5, 4.3 and 5.0 mm | Ø 4.1 mm and 4.8 mm | Ø 3.8 to 6.5 mm | In the range of
diameters of the
primary predicate and
the reference devices. |
| Implant
Length | 6 to 18 mm | 18 mm | 6 to 16 mm | 8.5 to 18 mm | In the range of lengths
of the primary
predicate and the
reference devices. |
| Implant
Body | Tapered body | Tapered body | Straight body | Straight and tapered body | Identical to primary
predicate and one of
the reference devices. |
| Thread
Pitch | 2.0 to 2.8 mm | 2.2 mm | 1.25 mm | Information not available | Similar to device
K150182. Both
implants have threads
designed to provide
proper primary stability
and allows for
immediate loading. |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE PREDICATE DEVICES | | EQUIVALENCE
DISCUSSION |
| | Subject Device – BLX
Implants | K150182
Neodent Implant System | K122855
Straumann Implant System | K101545
Genesis Implant System | |
| Sterilizatio
n Method | Irradiation | Irradiation | Irradiation | Irradiation | Identical. |
12
Straumann® BLX Implant System
510(k) Summary
13
Straumann® BLX Implant System
510(k) Summary
Table 1 - Comparison of subject device versus primary predicate device (Dental Implants)
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Straumann® BLX Implant System
510(k) Summary
| FEATURE | PROPOSED DEVICE | REFERENCE PREDICATE
DEVICE | EQUIVALENCE
DISCUSSION |
|--------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device - BLX Healing
components | K130808 | |
| Material | Titanium Grade 4
according to ISO 532-2 and
ISO 5832-11 | Titanium Grade 4 | Identical material. |
| Implant to
Abutment
Connection | BLX
(with conical fitting) | Synocta
CrossFit
(with conical fitting) | The subject devices
have a conical
implant-to-abutment
fitting as well as the
reference devices,
nevertheless, each
implant system has its
own engaging feature
in the conical
connection. |
| Prosthetic
Platform
Diameter | Closure Cap: NA
Healing Abutments:
Ø 4, 5, 6, 6.5 and 7.5 mm | Closure Cap: NA
Healing Abutment:
Ø 3.3 to 6.5 mm | Mostly into the range
of the reference device
diameters. 7.5 mm of
diameter does not
raise new safety issue. |
| Abutment
Heights | Closure Cap:
0.4 and 0.5 mm
Healing Abutments:
2.75 to 7.5 mm | Closure Cap:
0 mm and 1.5 mm
Healing Abutments:
2.0 to 7.0 mm | The heights of the
subject devices are
mostly into the range
of the reference
device. Some healing
abutments are 0.5mm
higher in order to
cover different clinical
situations and do not
introduce new safety
issue. |
| Sterilizatio
n Method | Irradiation | Irradiation | Identical to the
reference device. |
Table 2 - Comparison of subject device versus reference device (BLX Closure Cap and
BLX Healing Abutments)
15
Straumann® BLX Implant System
510(k) Summary
| FEATURE | PROPOSED DEVICE | REFERENCE PREDICATE DEVICE | EQUIVALENCE DISCUSSION |
|---|---|---|---|
| Subject Device – BLX | |||
| Temporary Abutments | K092814 | ||
| Straumann implant system | |||
| Material | Ti-6Al-7Nb | Ti-6Al-7Nb | Identical |
| Implant to | |||
| Abutment | |||
| Connection | BLX | ||
| (with conical fitting) | CrossFit® (NC) | ||
| (with conical fitting) | The subject devices | ||
| have a conical implant- | |||
| to-abutment fitting as | |||
| well as the reference | |||
| devices, nevertheless, | |||
| each implant system | |||
| has its own engaging | |||
| feature in the conical | |||
| connection. | |||
| Diameter | Ø 3.8, 4.5, 5.5 and 6 mm | Ø3.5 mm | The subject devices |
| have larger diameters | |||
| in order to match with | |||
| the diameters of the | |||
| new BLX implants. | |||
| Larger diameters do | |||
| not introduce a new | |||
| worst case in terms of | |||
| performance. | |||
| Gingival | |||
| Heights | 0.75, 1.5, 2.5 and 3.5 mm | 1.0 mm | The different gingival |
| heights are intended to | |||
| cover different clinical | |||
| situations and do not | |||
| introduce new safety | |||
| issue. | |||
| Chimney | |||
| Heights | 10 mm | 10 mm | Identical. |
| Angulation | Straight | Straight | Identical. |
| Sterilization | |||
| Method | Non-sterile/ | ||
| End user sterilized | Non-sterile/ | ||
| End user sterilized | Identical. |
Table 3 - Comparison of subject device versus reference predicate device (BLX Temporary Abutments)
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Straumann® BLX Implant System
510(k) Summary
| FEATURE | PROPOSED DEVICE | REFERENCE PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | EQUIVALENCE DISCUSSION |
|---|---|---|---|---|
| Subject Device - BLX | ||||
| Variobase Abutments | K170838 | |||
| Medentika TiBases | K142890 and K170354 | |||
| Straumann implant system | ||||
| Material | Ti-6Al-7Nb | Ti-6Al-4V | Ti-6Al-7Nb | Identical to reference |
| device K142890. | ||||
| Implant to | ||||
| Abutment | ||||
| Connection | BLX | |||
| (with conical fitting) | Several, according to the | |||
| implant lines referred in the | ||||
| Indications for Use statement | CrossFit® (SC) | |||
| (with conical fitting) | The subject devices | |||
| have a conical | ||||
| implant-to-abutment | ||||
| fitting as well as the | ||||
| Straumann reference | ||||
| devices, | ||||
| nevertheless, each | ||||
| implant system has its | ||||
| own engaging feature | ||||
| in the conical | ||||
| connection. | ||||
| Prosthetic | ||||
| Platform | ||||
| Diameter | diameter 3.8, 4.5, and 5.5 mm | diameter 3.25 to 6.0 mm | diameter 3.9 and 7.0 mm | Into the range of the |
| reference devices. | ||||
| Gingival Heights | 0.75 - 2.5 mm | 0.3 - 1.15 mm | 2.0 and 3.0 mm | Into the range of the |
| reference devices. | ||||
| Chimney Heights | 5.5 mm | |||
| (can be reduced) | 3.5 and 5.5 mm | 3.5 and 5.5 mm | Into the range of the | |
| reference devices. | ||||
| Design Workflow | Wax-up or | |||
| Straumann CARES® Visual, | ||||
| Dental Wings software using | ||||
| the Straumann CARES Visual | ||||
| Plug-In and 3Shape | Straumann CARES System | Wax-up or | ||
| Straumann CARES® Visual, | ||||
| Dental Wings software using | ||||
| the Straumann CARES Visual | ||||
| Plug-In and 3Shape | Identical to the | |||
| Straumann reference | ||||
| devices. | ||||
| Manufacturing | ||||
| Workflow | Straumann Milling | Straumann Milling | Traditional casting or pressing | |
| or | ||||
| Straumann Milling | Into the range of the | |||
| reference devices. | ||||
| FEATURE | PROPOSED DEVICE | REFERENCE PREDICATE DEVICE | EQUIVALENCE DISCUSSION | |
| Subject Device - BLX | ||||
| Variobase Abutments | K170838 | |||
| Medentika TiBases | K142890 and K170354 | |||
| Straumann implant system | ||||
| Coping/ Crown | ||||
| Material | Digital materials: | |||
| IPS e.max CAD | ||||
| Polycon® ae | Zirconia | |||
| IPS e.max CAD | Cast materials: | |||
| Type 4 metals (ISO 22674) | ||||
| Press materials: | ||||
| IPS e.max® Press Ceramic | ||||
| Digital materials: | ||||
| Coron® | ||||
| Zerion® | ||||
| IPS e.max CAD | ||||
| n!ce | ||||
| Polycon® ae | Into the range of the | |||
| reference devices. | ||||
| Coping/ Crown | ||||
| Angulation | Up to 30° | Up to 30° | Up to 30° | Identical. |
| Sterilization | ||||
| Method | Non-sterile/ | |||
| End user sterilized | Non-sterile/ | |||
| End user sterilized | Non-sterile/ | |||
| End user sterilized | Identical to the | |||
| reference devices. | ||||
| Mode of Action | Screw-retained or cement | |||
| retained | Screw-retained or cement | |||
| retained | Screw-retained or cement | |||
| retained | Identical to the | |||
| reference devices. |
17
Straumann® BLX Implant System
510(k) Summary
Table 4 - Comparison of subject device versus reference device (BLX Variobase Abutments)
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Straumann® BLX Implant System
510(k) Summary
5.7 Performance Testing
The following performance data were provided in support of the substantial equivalence determination.
5.7.1 Sterilization Validation and Shelf Life
The BLX implants, closure caps and healing abutments are provided sterile via gamma irradiation at a dose of 25 kilogray (2.5 Mrad) minimum. A sterility assurance level (SAL) of 10° had been validated in accordance with ISO 11137-1:2006, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, 2006-04-05. The validation method used was the over kill bioburden method in accordance with ISO 11137-2:2013, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose.
The BLX Temporary Abutments and BLX Variobase Abutments needs to be end-user sterilized by moist heat (steam). The recommended sterilization has been validated according to ISO 17665-1 and ISO 17665-2 and to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". There are no changes to the sterilization procedures or processes from those of the Straumann predicate devices. The packaging of all BLX devices is equivalent to the packaging of the predicate and reference device and so the shelf life for sterile devices remains to be 5 years since the materials are not adversely affected by the time.
Pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016." The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device.
5.7.2 Biocompatibility Testing
Biological assessment has been performed according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and to the FDA Guidance document "Use of International Standard ISO 10993- 1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016" for each of the subject devices.
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Straumann® BLX Implant System
510(k) Summary
The subject devices have the equivalent nature of body contact, contact duration, material formulation and sterilization methods compared to the primary and reference predicate devices. Differences in the manufacturing process have been assessed via Chemical Characterization and Cytotoxicity tests.
5.7.3 Bench Testing
Dynamic fatigue, static strength, insertion torque tests, pullout strength tests, surface area analysis, and bone-to-implant contact analysis were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the Straumann BLX Implant System is equivalent to the predicate and reference devices.
Dynamic fatigue (and static strength) tests were performed to evaluate the fatigue load limits of the proposed Straumann BLX Implants. Based on worst case considerations, both platforms RB and WB were tested and proved equivalent to the reference devices.
Insertion torque tests were conducted on the worst case defined for each diameter (Ø4.5, Ø 5.5 and Ø 6.5 mm) of the BLX portfolio: the shortest implant (6 mm), the middle length implant (12 mm) and the longest implant (18 mm). With this test, it was demonstrated that the BLX Implants and the related cutting instruments allow reaching suitable implant insertion torques.
Pullout strength tests, surface area analysis and bone-to-implant contact analysis were performed for the 6mm long BLX implants with Ø 4.5, 5.5 and 6.5 mm and equivalency to the reference devices was demonstrated.
5.7.4 Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided according to the FDA guidance documents "Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations" and "General Principles of Software Validation; Final Guidance for Industry and FDA Staff". The software for this device was considered as a "moderate" level of concern.
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Straumann® BLX Implant System
510(k) Summary
Also, software implementation verification provided demonstrates that all subject Variobase devices plus the modeling components within the new BLX portfolio are suitable to work together into the defined digital workflow to produce copings or crowns that properly fit and compose the final two-piece abutment.
5.7.5 Clinical data
No device specific clinical data has been submitted to demonstrate substantial equivalence.
5.8 Conclusion
The documentation submitted in this premarket notification demonstrates the Straumann® BLX implants, BLX Closure Caps and Healing Abutments, BLX Temporary Abutments, and Variobase Abutments are substantially equivalent to the primary predicate and reference devices.