(90 days)
No
The summary describes a dental implant system and its physical characteristics, materials, and performance testing, with no mention of AI or ML.
Yes
The device is described as suitable for "functional and esthetic oral rehabilitation of edentulous and partially edentulous patients" and to "restore chewing function," indicating its intended use to treat a medical condition and restore function.
No
The device description indicates that the Straumann BLX Implants are endosseal implants used for oral rehabilitation, restoring chewing function. Its intended use is for implantation, not for identifying a disease or condition.
No
The device description clearly indicates it is a physical implant made of Roxolid material with specific dimensions and surface finishes, intended for surgical implantation. It also mentions bench testing related to physical properties and biocompatibility, which are not relevant to software-only devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation in the jaw to support dental prosthetics. This is a therapeutic and restorative function, not a diagnostic one.
- Device Description: The description details the physical characteristics of a dental implant, including material, surface, connection type, and dimensions. These are all features of a surgically implanted device.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a patient's health status or condition.
- Performance Studies: The performance studies described (bench testing, biocompatibility, sterilization) are typical for surgically implanted medical devices, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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 placed with immediate function on single-tooth and multi-unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are connected to the implants through the corresponding abutment components.
Product codes
DZE
Device Description
The BLX Implants are fully tapered implants manufactured utilizing the Roxolid material and finished with the SLA or SLActive surface. The connection is identified as conical fitting with the Torx style engaging feature. The subject BLX implants have endosteal implant diameters of Ø3.75 and Ø4.0 mm with a length of 6 mm and are presented with one prosthetic platform: RB (Regular Base). The internal connection and the prosthetic platform are identical for all subject devices.
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)
Bench Testing:
Dynamic fatigue testing was 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 subject BLX Implants System is equivalent to the predicate and reference devices. The test was conducted in saline (2 Hz and 37°C) at 2 million cycles covering permanent restoration of the implant without failure.
Insertion tests were performed for the subject devices and it could be proven that there is an adequate insertion torque in different bone classes when the implant is inserted according to the surgical procedure.
Surface area comparison and pull-out testing were leveraged from K200586 as the endosseous surface area of the subject implants is identical to the referenced implants from K200586.
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 device materials are identical to the predicate and reference device materials, therefore, no new issues regarding biocompatibility were raised.
Sterilization Validation and Packaging:
The sterilization process for the subject BLX Implant System as recommended in the labeling was validated to a sterility assurance level (SAL) of 10-6 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 packaging of the subject BLX Implant System is equivalent to the packaging of the predicate and reference device. The shelf life for devices provided sterile is 5 years. The devices will not be marketed as non-pyrogenic. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and consists of the letters "FDA" and the words "U.S. Food & Drug Administration".
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K210855
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 Dated: March 22, 2021 Received: March 23, 2021
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality 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 are suitable for endosted implantation in the upper and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX implants can placed with immediate function on single-tooth and multi-unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are connected to the implants through the corresponding abutment components.
| 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 Implant System
510(k) Summary
510(k) Summary
Submitter's Contact Information
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052 | | |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | On the behalf of:
Institut Straumann AG
Peter Merian weg 12
4052 Basel, Switzerland | | |
| Contact Person: | Jennifer M. Jackson, MS
Director of Regulatory Affairs
Phone Number: +1-978-747-2509
Fax Number: +1-978-747-0023 | | |
| Prepared By: | Viviana Horhoiu
Regulatory Affairs and Compliance Manager
Institut Straumann AG
Phone number: +41 61 965 1260 | | |
| Date of Submission: | June 21, 2021 | | |
Name of the Device
| Trade Names: | Straumann® BLX Implant System |
|---|---|
| Common Name: | Endosseous dental implant |
| Classification Name: | Endosseous dental implant |
| Regulation Number: | §872.3640 |
| Device Classification: | II |
| Product Code(s): | DZE |
4
Straumann® BLX Implant System
510(k) Summary
Predicate Device(s)
Primary Predicate:
-
. K181703 – Straumann BLX Line Extension – Implants, SRAs, and Anatomic Abutments (Institut Straumann AG)
Reference Devices: -
. K200586 – Straumann TLX Implant System (Institut Straumann AG)
-
K150938 Straumann Dental Implant System Roxolid SLA Implants (Institut . Straumann AG)
Device Description
The BLX Implants are fully tapered implants manufactured utilizing the Roxolid material and finished with the SLA or SLActive surface. The connection is identified as conical fitting with the Torx style engaging feature. The subject BLX implants have endosteal implant diameters of Ø3.75 and Ø4.0 mm with a length of 6 mm and are presented with one prosthetic platform:
- . RB (Regular Base)
The internal connection and the prosthetic platform are identical for all subject devices.
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 placed with immediate function on single-tooth and multi-unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are connected to the implants through the corresponding abutment components.
Technological Characteristics
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in Table 1.
5
Straumann® BLX Implant System
510(k) Summary
| Feature | Proposed Device | Primary Predicate Device | Primary Predicate Device | Reference Device |
|---|---|---|---|---|
| Subject | ||||
| Straumann BLX Implant | ||||
| System | K181703 | |||
| Straumann BLX Line | ||||
| Extension - Implants, SRAs, | ||||
| and Anatomic Abutments | K200586 | |||
| Straumann TLX Implant | ||||
| System | K150938 | |||
| Straumann Dental Implant | ||||
| System - Roxolid SLA | ||||
| 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 placed with | ||||
| immediate function on single- | ||||
| tooth and multi-unit restorations | ||||
| when good primary stability is | ||||
| achieved and with appropriate | ||||
| occlusal loading, to restore | ||||
| chewing function. The prosthetic | ||||
| restorations used 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, 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 TLX Implants are | |||
| suitable for endosteal | ||||
| implantation in the upper and | ||||
| lower jaws and for the functional | ||||
| and esthetic oral rehabilitation of | ||||
| edentulous and partially | ||||
| edentulous patients. TLX | ||||
| Implants can be placed with | ||||
| immediate function on single- | ||||
| tooth and multi-unit restorations | ||||
| 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® dental implants are | |||
| indicated for oral endosteal | ||||
| implantation in the upper and | ||||
| lower jaw and for the functional | ||||
| and esthetic oral rehabilitation of | ||||
| edentulous and partially dentate | ||||
| patients. 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). | ||||
| Material | Titanium-13 Zirconium alloy | |||
| (Roxolid®) | Titanium-13 Zirconium alloy | |||
| (Roxolid®) | Titanium-13 Zirconium alloy | |||
| (Roxolid®) | Titanium-13 Zirconium alloy | |||
| (Roxolid®) | ||||
| Surface | ||||
| Treatment | Hydrophilic SLActive® and SLA® | Hydrophilic SLActive® | Hydrophilic SLActive® | SLA® |
| Implant to | ||||
| Abutment | ||||
| Connection | TorcFit | |||
| (with conical fitting) | TorcFit | |||
| (with conical fitting) | TorcFit | |||
| (with conical fitting) | CrossFit | |||
| Implant | ||||
| Diameter | Ø3.75 and 4.0 mm | Ø3.75 mm | Ø3.75, 4.0, 4.5, 5.0, 5.5, and 6.5 | |
| mm | Ø 3.3, 4.1, and 4.8 mm | |||
| Feature | Proposed Device | Primary Predicate Device | Primary Predicate Device | Reference Device |
| Subject | ||||
| Straumann BLX Implant | ||||
| System | K181703 | |||
| Straumann BLX Line | ||||
| Extension - Implants, SRAs, | ||||
| and Anatomic Abutments | K200586 | |||
| Straumann TLX Implant | ||||
| System | K150938 | |||
| Straumann Dental Implant | ||||
| System - Roxolid SLA | ||||
| Implant Length | 6 mm | 8, 10, 12, 14, 16, and 18 mm | Ø3.75, 4.0, 4.5, 5.0 mm: | |
| 6, 8, 10, 12, 14, 16 and 18 mm | ||||
| Ø5.5 and 6.5 mm: | ||||
| 6, 8, 10, 12 mm | 6, 8, 10, 12, 14 and 16 mm | |||
| Implant Design | Tapered body | Tapered body | Tapered body | Parallel and tapered body |
| Prosthetic | ||||
| platforms | RB | RB | NT, RT, and WT | N/A |
| Sterilization | ||||
| Method | Irradiation | Irradiation | Irradiation | Irradiation |
| MR Labeling | MR Conditional | N/A | MR Conditional | N/A |
6
Straumann® BLX Implant System
510(k) Summary
Table 1 – Comparison of subject device versus predicate devices – BLX Implant System
7
Straumann® BLX Implant System
510(k) Summary
Performance Testing
Bench Testing
Dynamic fatigue testing was 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 subject BLX Implants System is equivalent to the predicate and reference devices. The test was conducted in saline (2 Hz and 37°C) at 2 million cycles covering permanent restoration of the implant without failure.
Insertion tests were performed for the subject devices and it could be proven that there is an adequate insertion torque in different bone classes when the implant is inserted according to the surgical procedure.
Surface area comparison and pull-out testing were leveraged from K200586 as the endosseous surface area of the subject implants is identical to the referenced implants from K200586.
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 device materials are identical to the predicate and reference device materials, therefore, no new issues regarding biocompatibility were raised.
Sterilization Validation and Packaqing
The sterilization process for the subject BLX Implant System as recommended in the labeling was validated to a sterility assurance level (SAL) of 10-6 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-
8
Straumann® BLX Implant System
510(k) Summary
2:2013, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose. The packaging of the subject BLX Implant System is equivalent to the packaging of the predicate and reference device. The shelf life for devices provided sterile is 5 years. The devices will not be marketed as non-pyrogenic. 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.
Conclusion
The documentation submitted in this premarket notification demonstrates the subject Straumann BLX Implant System is substantially equivalent to the primary predicate and reference devices.