(231 days)
No
The summary describes a dental implant and its physical characteristics, materials, and testing. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes
The device is used for functional and esthetic oral rehabilitation, restoring chewing function, which indicates a therapeutic purpose.
No
Explanation: The device is an implant for oral rehabilitation, designed to restore chewing function. There is no indication that it is used to diagnose a medical condition.
No
The device description clearly states it is a physical implant made of Roxolid material with a specific surface finish and connection type, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients." This describes a surgical implant used within the body for structural support and restoration of function.
- Device Description: The description details a dental implant made of Roxolid material with a specific surface and connection type. This is a physical device implanted into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically reagents, instruments, or systems used in vitro (outside the body).
Therefore, the Straumann® BLX Implants are a medical device, specifically a dental implant, and not an In Vitro Diagnostic device.
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 be placed with immediate function on singletooth, 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 by the corresponding abutment components.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The Straumann BLX Ø3.5 mm Implants are fully tapered implants manufactured utilizing the Roxolid material and are finished with SLActive® surface. The BLX connection is identified as conical fitting with Torx style engaging feature (TorcFit connection). There are two available prosthetic platforms identified for BLX Implants: RB (Regular Base) and WB (Wide Base). The subject devices have a RB platform with a TorcFit 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 | Maximium outer Ø (mm) | Length (mm) |
|---|---|---|
| RB | 3.5 | 8 |
| 10 | ||
| 12 | ||
| 14 | ||
| 16 | ||
| 18 |
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 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 device meets pyrogen limit specifications determined by LAL Endotoxin Analysis (testing limit is 20 EU/device). The packaging is equivalent to predicate devices, and the shelf life is 5 years.
Biocompatibility Testing: Biological assessment performed according to ISO 10993-1:2009 and FDA Guidance document "Use of International Standard ISO 10993-1...". No new testing performed as subject devices have equivalent nature of body contact, contact duration, material formulation, and sterilization methods compared to primary predicate devices.
Bench Testing: Dynamic fatigue, static strength, and insertion torque tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments". Dynamic fatigue tests (in 0.9% NaCl at 37°) showed equivalence to predicate devices. Insertion torque tests on worst cases demonstrated that BLX Implants and 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.
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 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 27, 2019
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801
Re: K191256
Trade/Device Name: Straumann BLX Ø3.5 mm Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: November 22, 2019 Received: November 25, 2019
Dear Jennifer Jackson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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.
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name:
Straumann BLX Ø3.5 mm Implants
Indications for Use (Describe)
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, 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 by the corresponding abutment components.
Type of Use (Select one or both, as applicable) 区Prescription Use (Part 21 CFR 801 Subpart D)
□Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED
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FORM FDA 3881 (7/17)
3
K191256 – Traditional 510(k)
Straumann BLX Ø3.5 mm Implants
510(k) Summary
5 510(k) Summary
Submitter's Contact Information 5.1
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer M. Jackson, MS
Director of Regulatory Affairs and Quality
Phone Number: +1-978-747-2509
Fax Number: +1-978-747-0023 |
| Prepared By &
Alternate Contact: | Ana C. M. Vianna
Regulatory Affairs and Compliance Manager
Institut Straumann AG
Phone number : +41 61 965 1259 |
| Date of Submission: | December 26, 2019 |
5.2 Name of the Device
| Trade Names: | Straumann BLX Ø3.5 mm Implants |
|---|---|
| Common Name: | Endosseous dental implant |
| Classification Name: | Endosseous dental implant |
| Regulation Number: | §872.3640 |
| Device Classification: | II |
| Product Code(s): | DZE |
| Classification Panel: | Dental |
5.3 Predicate Device(s)
Primary Predicate:
- K181703 Straumann BLX Line Extension Implants, SRAs and Anatomic . Abutments
4
K191256 - Traditional 510(k)
Straumann BLX Ø3.5 mm Implants
510(k) Summary
Reference Devices:
- . K130222 - Straumann Dental Implant System
Device Description 5.4
The Straumann BLX Ø3.5 mm Implants are fully tapered implants manufactured utilizing the Roxolid material and are finished with SLActive® surface. The BLX connection is identified as conical fitting with Torx style engaging feature (TorcFit connection). There are two available prosthetic platforms identified for BLX Implants: RB (Regular Base) and WB (Wide Base). The subject devices have a RB platform with a TorcFit 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 | Maximium outer Ø (mm) | Length (mm) |
|---|---|---|
| RB | 3.5 | 8 |
| 10 | ||
| 12 | ||
| 14 | ||
| 16 | ||
| 18 |
5.5 Intended Use
The Straumann dental implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of patients with missing teeth.
5.6 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 singletooth, 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 by the corresponding abutment components.
5
K191256 – Traditional 510(k)
Straumann BLX Ø3.5 mm Implants
510(k) Summary
Technological Characteristics 5.7
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | PRIMARY PREDICATE DEVICE |
|---|---|---|---|
| K Number | Straumann BLX Ø3.5 mm Implants | K181703 | K130222 |
| 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 by the corresponding | |||
| abutment components. | The 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 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 Dental implants are indicated | ||
| for oral endosteal implantation in the upper | |||
| and lower jaw arches for the functional and | |||
| aesthetic oral rehabilitation of edentulous | |||
| and partially dentate patients. Straumann® | |||
| Dental implants are also indicated 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 through the corresponding | |||
| components (abutments). | |||
| Material | Roxolid | Roxolid | Roxolid |
| Surface Treatment | SLActive® | SLActive® | SLActive® |
| Implant to Abutment | |||
| Connection | BLX TorcFit connection | BLX TorcFit connection | RN, WN, NC, RC |
| Implant Diameter | 3.5 mm | 3.75 mm | 3.3 to 4.8 mm |
| Implant Length | 8 to 18 mm | 8 to 18 mm | 6 to 16 mm |
| Implant Design | BLX fully tapered body | BLX fully tapered body | Cylindrical and partially tapered |
| Sterilization Method | Irradiation | Irradiation | Irradiation |
Table 1 – Comparison of subject device versus primary predicate device (Dental Implants)
6
K191256 – Traditional 510(k)
Straumann BLX Ø3.5 mm Implants
510(k) Summary
Performance Testing 5.8
5.8.1 Sterilization Validation and Shelf Life
The BLX implants are provided sterile via gamma irradiation at a dose of 25 kilogray (2.5 Mrad) minimum. A sterility assurance level (SAL) of 10-6 has been validated in accordance with ISO 11137-1:2006, Sterilization of health care products - Radiation -Part 1: Requirements for development, validation and routine control of a 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 subject devices will not be marketed as non-pyrogenic. The method used to make the determination that the device meets pyrogen limit specifications is LAL Endotoxin Analysis. The testing limit is 20 EU/device.
The packaging of the subject devices is equivalent to the packaging of the predicate devices 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.
5.8.2 Biocompatibility Testing
Biological assessment has been performed according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and to the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016" for each of the subject devices.
The subject devices have equivalent nature of body contact, contact duration, material formulation and sterilization methods compared to the primary predicate devices and therefore no new testing has been performed.
7
K191256 - Traditional 510(k)
Straumann BLX Ø3.5 mm Implants
510(k) Summary
5.8.3 Bench Testing
Dynamic fatigue, static strength, and insertion torque tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the Straumann BLX Implant System is equivalent to the predicate devices.
Dynamic fatigue (and static strength) tests were performed to evaluate the fatigue load limits of the proposed Straumann BLX Implants. The test environment was 0.9% NaCl at 37°. The results show the subject devices are equivalent to the predicate devices. Insertion torque tests were conducted on the worst cases defined for BLX Ø3.5 mm implants.
With this test, it was demonstrated that the BLX Implants and the related cutting instruments allow reaching suitable implant insertion torques.
5.8.4 Clinical data
No device specific clinical data has been submitted to demonstrate substantial equivalence.
5.9 Conclusion
The documentation submitted in this premarket notification demonstrates the Straumann BLX Ø3.5 mm implants are substantially equivalent to the primary predicate devices.