(184 days)
No
The document describes dental implants and abutments, focusing on materials, design, and intended use for oral rehabilitation. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device, Straumann® BLX Implants and their associated prosthetic components, are intended for the "functional and esthetic oral rehabilitation of edentulous and partially edentulous patients" and to "restore chewing function," which are therapeutic purposes as they treat a condition and restore bodily function.
No
The device description focuses on the physical components of dental implants and abutments used for functional and esthetic oral rehabilitation, not for diagnosing conditions. Its intended use is described as an aid in prosthetic rehabilitation to restore chewing function, not to identify or characterize diseases or conditions.
No
The device description clearly details physical implants and abutments made of materials like Roxolid and TAN, which are hardware components. There is no mention of software as the primary or sole component of the device.
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 restoring chewing function. This is a surgical and prosthetic application, not a diagnostic one.
- Device Description: The description details the materials, design, and components of dental implants and abutments, which are physical devices implanted or attached to the jawbone.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status or disease.
- Performance Studies: The performance studies listed are related to the physical properties and safety of the implant and abutments (sterilization, biocompatibility, mechanical strength), not diagnostic accuracy.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for structural and functional restoration.
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 patients. BLX Implants can be placed with immediate function on single-tooth, bar and bridge 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 SRAs and Antomic 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 abutments may be placed into occlusion when the implant is fully osseointegrated. BLX Temporary Abutments have a maximum duration of usage of 180 days.
Product codes (comma separated list FDA assigned to the subject device)
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. There are two available prosthetic platforms identified as RB (Regular Base) and WB (Wide Base).
The subject devices have a RB platform (a "small top/head") with a Torx-style internal connection, which is identical for all the implant lengths. They are provided sterile by gamma radiation and are available in the following sizes:
| Platform | Neck Ø (mm) | Maximum outer Ø (mm) | Length (mm) |
|---|---|---|---|
| RB | 3.5 | 3.75 | 8 |
| 10 | |||
| 12 | |||
| 14 | |||
| 16 | |||
| 18 |
Straumann® BLX SRAs are manufactured from TAN and are intended to be placed on BLX Straumann dental implants to provide support for permanent screw-retained single or multi-unit restorations. They are provided sterile by gamma radiation and are available in the following sizes:
| Platform | Ø (mm) | Angulation | Gingival heights (mm) |
|---|---|---|---|
| RB/WB | 4.6 | 0° | 1.5 |
| 0° | 2.5 | ||
| 0° | 3.5 | ||
| 4.5 | |||
| RB/WB | 4.6 | 17° | 2.5 |
| 17° | 3.5 | ||
| 17° | 4.5 | ||
| RB/WB | 4.6 | 30° | 2.5 |
| 30° | 3.5 | ||
| 30° | 4.5 |
The angled versions are composed of the body of the abutment with a coupled basal screw whereas in the straight version both parts are machined in one piece.
The SRAs are provided with a transfer piece (Pin).
Straumann® BLX Anatomic Abutments are manufactured from TAN and are intended to be placed on BLX Straumann dental implants to provide support for permanent cementretained single or multi-unit restorations. They are provided non-sterile and are available in the following sizes:
| Platform | Angulation | Gingival heights (mm) |
|---|---|---|
| RB/WB | 0° | 2.5 |
| 3.5 | ||
| RB/WB | 17° | 2.5 |
| 3.5 |
They are delivered with the corresponding basal screw.
Anatomic Abutments are provided with pre-defined mucosa margins and with a size that allows for further modification by the customer via hand grinding tools.
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 / Population
edentulous patients; edentulous and partially edentulous patients.
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 and SRAs 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. The validation method used was the over kill bioburden method in accordance with ISO 11137-2:2013. The packaging of the BLX sterile devices is equivalent to the packaging of the predicate and reference device and the shelf life is 5 years.
The BLX Anatomic 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.
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.
Biocompatibility Testing: Biological assessment has been performed according to ISO 10993-1:2009 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. No new testing has been performed as the subject devices have equivalent nature of body contact, contact duration, material formulation and sterilization methods compared to the primary and reference predicate devices.
Bench Testing: Dynamic fatigue, static strength, and insertion torque tests were conducted according to the FDA quidance 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. Both platforms RB and WB were tested and shown to be equivalent to the reference devices.
Insertion torque tests were conducted on the worst cases defined for BLX implants Ø3.75 mm. It was demonstrated that the BLX Implants and the related cutting instruments allow reaching suitable implant insertion torques.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K071357, K133421, K171757, K163194
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.
December 28, 2018
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801
Re: K181703
Trade/Device Name: Straumann® BLX Line Extension - Implants, SRAs and Anatomic Abutments Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 27, 2018 Received: November 28, 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. 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.
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) 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 (OS) 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 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.
Andrew I. Steen -S
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
2
Indications for Use
510(k) Number (if known) K181703
Device Name
Straumann® BLX Line Extension - Implants, SRAs and Anatomic Abutments
Indications for Use (Describe)
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 patients. BLX Implants can be placed with immediate function on single-tooth, bar and bridge 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 SRAs and Antomic 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 abutments may be placed into occlusion when the implant is fully osseointegrated. BLX Temporary Abutments have a maximum duration of usage of 180 days.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Straumann® BLX Line Extension - Implants, SRAs, and Anatomic Abutments
510(k) Summary
Submitter's Contact Information
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: December 28, 2018
Name of the Device
| Trade Names: | Straumann® BLX Line Extension – Implants, SRAs and Anatomic
Abutments |
|----------------------|--------------------------------------------------------------------------|
| Common Name: | Endosseous Dental Implant |
| Classification Name: | Endosseous Dental Implant |
| Regulation Number: | 21 CFR 872.3640
21 CFR 872.3630 |
| Classification: | Class II |
| Product Codes: | Primary product code DZE
Secondary product code NHA |
Predicate Device(s)
Primary Predicate:
4
Straumann® BLX Line Extension - Implants, SRAs, and Anatomic Abutments
- K133421 Straumann Magellan Abutment, Protective Cap, Titanium Copings, . Gold Copings, Basal Screw
- . K171757 – Straumann Screw Retained Abutments
- K163194 Neodent Implant System GM Line .
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 singletooth, bar and bridges 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 SRAs and Anatomic 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.
4.1 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. There are two available prosthetic platforms identified as RB (Regular Base) and WB (Wide Base).
5
Straumann® BLX Line Extension - Implants, SRAs, and Anatomic Abutments
The subject devices have a RB platform (a "small top/head") with a Torx-style internal connection, which is identical for all the implant lengths. They are provided sterile by gamma radiation and are available in the following sizes:
| Platform | Neck Ø
(mm) | Maximum outer Ø
(mm) | Length
(mm) |
|----------|----------------|-------------------------|----------------|
| RB | 3.5 | 3.75 | 8 |
| | | | 10 |
| | | | 12 |
| | | | 14 |
| | | | 16 |
| | | | 18 |
Straumann® BLX SRAs are manufactured from TAN and are intended to be placed on BLX Straumann dental implants to provide support for permanent screw-retained single or multi-unit restorations. They are provided sterile by gamma radiation and are available in the following sizes:
| Platform | Ø
(mm) | Angulation | Gingival
heights
(mm) |
|----------|-----------|------------|-----------------------------|
| RB/WB | 4.6 | 0° | 1.5 |
| | | 0° | 2.5 |
| | | 0° | 3.5 |
| | | | 4.5 |
| RB/WB | 4.6 | 17° | 2.5 |
| | | 17° | 3.5 |
| | | 17° | 4.5 |
| RB/WB | 4.6 | 30° | 2.5 |
| | | 30° | 3.5 |
| | | 30° | 4.5 |
The angled versions are composed of the body of the abutment with a coupled basal screw whereas in the straight version both parts are machined in one piece.
The SRAs are provided with a transfer piece (Pin).
6
Straumann® BLX Line Extension - Implants, SRAs, and Anatomic Abutments
Straumann® BLX Anatomic Abutments are manufactured from TAN and are intended to be placed on BLX Straumann dental implants to provide support for permanent cementretained single or multi-unit restorations. They are provided non-sterile and are available in the following sizes:
| Platform | Angulation | Gingival heights (mm) |
|---|---|---|
| RB/WB | 0° | 2.5 |
| 3.5 | ||
| RB/WB | 17° | 2.5 |
| 3.5 |
They are delivered with the corresponding basal screw.
Anatomic Abutments are provided with pre-defined mucosa margins and with a size that allows for further modification by the customer via hand grinding tools.
Technological Characteristics
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following tables:
7
Straumann® BLX Line Extension – Implants, SRAs, and Anatomic Abutments
| | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE
DEVICE | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FEATURE | | K173961 | K163194 | EQUIVALENCE DISCUSSION |
| | Subject Device - BLX Implants | Straumann BLX Implant System | Neodent GM Line | |
| 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,
bar and bridge 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 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. | Equivalent
All indications allows for implant
placement in jaw, providing
support for single-tooth, bar and
bridge restorations, and allowing
for immediate loading when good
primary stability is achieved. |
| Material | Titanium-13 Zirconium alloy
(Roxolid®) | Titanium-13 Zirconium alloy
(Roxolid®) | Titanium grade 4 | Identical
Identical to the primary predicate
device. |
| Surface
Treatment | Hydrophilic SLActive® | Hydrophilic SLActive® | Acqua | Identical
Identical to the primary predicate
device. |
| Implant to
Abutment
Connection | BLX
(with conical fitting) | BLX
(with conical fitting) | GM interface
(with conical fitting) | Equivalent
All connections have conical
fitting. |
| Implant
Diameter | Ø 3.75 mm | Ø 4.5, 5.5, 6.5 mm | Ø 3.5 to 5.0 mm | Equivalent
Into the range of diameters of the
primary predicate and the
reference devices. |
| FEATURE | PROPOSED DEVICE
Subject Device - BLX Implants | PRIMARY PREDICATE DEVICE
K173961
Straumann BLX Implant System | REFERENCE PREDICATE DEVICE
K163194
Neodent GM Line | EQUIVALENCE DISCUSSION |
| Implant Length | 8 to 18 mm | 6 to 18 mm | 8 to 18 mm | Equivalent
Into the range of the predicate
device and identical to the
reference device. |
| Implant Body | Tapered body | Tapered body | Tapered and cylindrical bodies | Equivalent
Into the range of body shapes of
the primary predicate and the
reference devices. |
| Thread Pitch | 1.7 to 2.6 | 2.0 to 2.8 mm | Not available. | Equivalent
The performance of the different
thread pitches are assessed via
insertion torque test. |
| Sterilizatio
n Method | Irradiation | Irradiation | Irradiation | Identical. |
8
Straumann® BLX Line Extension - Implants, SRAs, and Anatomic Abutments
Table 1 – Comparison matrix: subject device versus primary and reference predicate devices (BLX Implants)
9
Straumann® BLX Line Extension – Implants, SRAs, and Anatomic Abutments
| PROPOSED DEVICE | REFERENCE PREDICATE DEVICE | |||
|---|---|---|---|---|
| FEATURE | Subject Device - BLX SRAs | K133421 | ||
| (Straumann Magellan | ||||
| SRAs) | K171757 | |||
| Straumann Screw | ||||
| Retained Abutments | EQUIVALENCE DISCUSSION | |||
| Material | Ti-6Al-7Nb | Ti-6Al-7Nb | Ti-6Al-7Nb | Identical |
| Implant to | ||||
| Abutment | ||||
| Connection | BLX | |||
| (with conical fitting) | CrossFit® (NC and RC) | |||
| (with conical fitting) | CrossFit® (NC and RC) | |||
| (with conical fitting) | Equivalent | |||
| 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. | ||||
| Platform | ||||
| Diameter | Ø 4. 6 mm | Ø 3.5 and 4.6 mm | Ø 3.5 and 4.6 mm | Equivalent |
| Into the range of the reference devices'. | ||||
| Gingival | ||||
| Heights | 1.5, 2.5, 3.5 and 4.5 mm | 1.0, 2.5 and 4.0 mm | 1.0, 2.5, 4.0 and 5.5 mm | Equivalent |
| The gingival heights of the subject | ||||
| devices are into the range of the | ||||
| reference devices'. | ||||
| Angulation | 0, 17 and 30° | 0, 17 and 30° | 0, 17 and 30° | Identical |
| Sterilization | ||||
| Method | Sterile by gamma radiation | Non-sterile/ | ||
| End user sterilized | Sterile by gamma radiation | Identical | ||
| To one of the reference devices. | ||||
| Prosthesis | ||||
| type | Screw-retained | Screw-retained | Screw-retained | Identical. |
Table 2 – Comparison matrix: subject device versus reference device (SRAs)
10
Straumann® BLX Line Extension - Implants, SRAs, and Anatomic Abutments
| | PROPOSED DEVICE | REFERENCE
PREDICATE DEVICE | EQUIVALENCE
DISCUSSION |
|--------------------------------------|--------------------------------------------|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FEATURE | Subject Device – BLX
Anatomic Abutments | K071357
(Straumann anatomic
abutments) | |
| Material | Ti-6Al-7Nb | Ti | Equivalent
Both materials are titanium
based. Differences in safety
and performance are
addressed via
biocompatibility and fatigue
assessment. |
| Implant to
Abutment
Connection | BLX
(with conical fitting) | CrossFit® (NC)
(with conical fitting) | Equivalent
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. |
| Gingival
Heights | 2.5 and 3.5 mm | 2 and 3.5 mm | Equivalent
The gingival heights of the
subject devices are into the
range of the reference
devices'. |
| Total abutment
height | 13.4 to 15.1 mm | 10.4 to 12.3 mm | Equivalent
All heights are compatible
with anatomical conditions.
Differences in the
performance are addressed
via fatigue performance
assessment. |
| Angulation | 0 and 17° | 0 and 15° | Equivalent
The difference in the
angulation is addressed via
performance assessment. |
| Sterilization
Method | Non-sterile/
End user sterilized | Non-sterile/
End user sterilized | Identical. |
| Prosthesis
type | Cement-retained | Cement-retained | Identical. |
Table 3 – Comparison matrix: subject device versus reference device (Anatomic Abutments)
Performance Testing
The following performance data support the substantial equivalence determination.
Sterilization Validation and Shelf Life
The BLX implants and SRAs 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 –
11
Straumann® BLX Line Extension - Implants, SRAs, and Anatomic Abutments
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 packaging of the BLX sterile devices 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 BLX Anatomic 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.
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 predicate devices and therefore no new testing has been performed.
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Straumann® BLX Line Extension - Implants, SRAs, and Anatomic Abutments
Bench Testing
Dynamic fatigue, static strength, and insertion torque tests were conducted according to the FDA quidance 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 shown to be equivalent to the reference devices.
Insertion torque tests were conducted on the worst cases defined for BLX implants Ø3.75 mm. With this test, it was demonstrated that the BLX Implants and the related cutting instruments allow reaching suitable implant insertion torques.
Clinical data
No device specific clinical data has been submitted to demonstrate substantial equivalence.
Conclusion
The documentation submitted in this premarket notification demonstrates the Straumann® BLX implants, SRAs and Anatomic Abutments are substantially equivalent to the primary predicate and reference devices.