BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
Device Facts
| Record ID | K212533 |
|---|---|
| Device Name | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants |
| Applicant | Institut Straumann AG |
| Product Code | DZE · Dental |
| Decision Date | Jan 28, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices.
Device Story
BLX WB dental implants are tapered endosseous implants manufactured from Roxolid (Titanium-13 Zirconium alloy) with SLActive or SLA surface treatments. Designed for surgical placement in upper or lower jaw arches to support prosthetic restorations (crowns, bridges, dentures). Features TorcFit conical internal connection with Torx-style engaging feature. Used by dental clinicians in clinical settings. Implants provide structural support for prosthetic devices, restoring chewing function and esthetics. Clinical benefit derived from osseointegration and immediate/early loading capabilities. Surgical placement requires assessment of vertical bone availability; x-ray reference tools recommended for anatomical structure protection.
Clinical Evidence
Bench testing only. Dynamic fatigue testing leveraged from reference device K173961. Insertion torque testing demonstrated equivalence to primary predicate. Biocompatibility assessment per ISO 10993-1 confirmed no new issues. Sterilization validated to SAL 10^-6 per ISO 11137-1/2. Pyrogenicity verified via LAL Endotoxin Analysis (limit 20 EU/device).
Technological Characteristics
Material: Roxolid (Titanium-13 Zirconium alloy). Surface: Hydrophilic SLActive or SLA. Connection: TorcFit (conical). Dimensions: Ø5.0mm (18mm length), Ø5.5mm/Ø6.5mm (14mm and 16mm lengths). Sterilization: Irradiation (SAL 10^-6). Packaging: Identical to predicate, 5-year shelf life.
Indications for Use
Indicated for functional and esthetic oral rehabilitation of upper or lower jaw of edentulous or partially edentulous patients. Used for immediate, early, or late implantation following tooth extraction or loss. Implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Straumann Dental Implant Systems (K130222)
Reference Devices
- Straumann BLX Implant System (K173961)
- Straumann TLX Implant System (K200586)
- Xpeed Anyridge Internal Implant Systems (K140091)
- MRI Compatibility for Existing Straumann Dental Implant Systems (K190662)
Related Devices
- K121131 — BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM · Straumann USA · Jun 6, 2012
- K230108 — Straumann® BLC and TLC Implants · Institut Straumann AG · Sep 14, 2023
- K191256 — Straumann BLX Ø3.5 mm Implants · Institut Straumann AG · Dec 27, 2019
- K234049 — Straumann® BLC and TLC Implants - Line extension · Institut Straumann AG · Mar 20, 2024
- K181703 — Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments · Institut Straumann AG · Dec 28, 2018
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K212533
Trade/Device Name: BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: December 23, 2021 Received: December 27, 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.
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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K212533
#### Device Name:
BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
#### Indications for Use (Describe)
Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for multipletooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Type of Use (Select one or both, as applicable) 図Prescription Use (Part 21 CFR 801 Subpart D)
□Over-The-Counter Use (21 CFR 801 Subpart C)
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# BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
# 510(k) Summary
# Submitter's Contact Information
| Submitter: | Straumann USA, LLC<br>60 Minuteman Road<br>Andover, MA 01810<br>Registration No.: 1222315 Owner/Operator No.: 9005052<br>On the behalf of:<br>Institut Straumann AG<br>Peter Merian-Weg 12<br>4052 Basel, Switzerland. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer M. Jackson, MS<br>Director of Regulatory Affairs and Quality<br>Phone Number: +1-978-747-2509<br>Fax Number: +1-978-747-0023 |
| Prepared By: | Corinne Arimatea<br>Regulatory Affairs and Compliance Manager<br>Institut Straumann AG<br>Phone Number: +41 61 965 1217 |
| Date of Submission: | January 28, 2022 |
## Name of the Device
| Trade Names: | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) 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 |
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# BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
### Predicate Device(s)
Primary Predicate:
- K130222 Straumann Dental Implant Systems .
Reference Device:
- K173961 Straumann BLX Implant System .
- . K200586 – Straumann TLX Implant System
- . K140091 - Xpeed Anyridge Internal Implant Systems
- K190662 MRI Compatibility for Existing Straumann Dental Implant Systems .
#### Device Description
The subject devices are part of the BLX implant line, a fully tapered implant manufactured out of Roxolid and having the SLActive or SLA surface. The connection is identified as conical fitting with the Torx style engaging feature. The subject BLX implants have endosteal implant diameters of Ø5.0mm and lengths of 18 mm and diameters of Ø5.5mm and Ø6.5mm and lengths of 14 mm and 16 mm. The subject devices are presented with the WB (Wide Base) prosthetic platform. The internal connection and the prosthetic platform are identical for all subject devices.
#### Intended Use
The Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices.
#### Indications for Use
Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
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# BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
510(k) Summary
## Technological Characteristics
The technological characteristics of the subject devices are compared to the primary predicate devices in Table 1. The Ø6.5 x 16 mm subject implant is longer than the predicate and reference devices. As such, the surgical procedure has been updated to provide further guidance for protection of critical anatomical structures:
"The vertical bone availability determines the maximum allowable length of the implant that can be placed. A minimum distance of 2 mm between the apex of the implant and the alveolar nerve should be kept. For easier determination of the vertical bone availability, we recommend the use of an x-ray reference foil with X-ray Reference Sphere (049.076V4)."
The Instructions for Use were also updated to include the following caution/precaution:
"Larger size implants are recommended for the molar region only."
The Indications for Use Statement is similar between the subject and primary predicate devices. The subject submission does not include abutments; therefore, the last sentence of the primary predicate Indications for Use has been omitted from the subject device Indications for Use. The other differences are minor wording changes that do not change the intended meaning of the Indications for Use.
The reference device K190662 is included for reference to the MRI compatibility.
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# BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
510(k) Summary
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE<br>DEVICE | REFERENCE DEVICE<br>(BLX IMPLANTS) | REFERENCE DEVICE<br>(TLX IMPLANTS) | REFERENCE DEVICE<br>(XPEED ANYRIDGE<br>IMPLANTS) |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K212533 | K130222 | K173961 | K200586 | K140091 |
| Indications<br>for Use | Straumann® dental<br>implants are indicated for<br>the functional and<br>esthetic oral rehabilitation<br>of the upper or lower jaw<br>of edentulous or partially<br>edentulous patients. They<br>can be used for<br>immediate, early or late<br>implantation following the<br>extraction or loss of<br>natural teeth. The<br>implants can be placed<br>with immediate function<br>for single-tooth and/or<br>multiple-tooth restorations<br>when good primary<br>stability is achieved and<br>with appropriate occlusal<br>loading to restore<br>chewing function. | Straumann® Dental<br>implants are indicated for<br>oral endosteal<br>implantation in the upper<br>and lower jaw arches for<br>the functional and<br>aesthetic oral<br>rehabilitation of<br>edentulous and partially<br>dentate patients.<br>Straumann® Dental<br>implants are also<br>indicated for immediate or<br>early implantation<br>following extraction or<br>loss of natural teeth.<br>Implants can be placed<br>with immediate function<br>on single-tooth and/or<br>multiple tooth applications<br>when good primary<br>stability is achieved and<br>with appropriate occlusal<br>loading to restore<br>chewing function. The<br>prosthetic restorations<br>used are single crowns,<br>bridges and partial or full<br>dentures, which are<br>connected to the implants<br>through the<br>corresponding<br>components (abutments). | Straumann® BLX<br>Implants are suitable for<br>endosteal implantation in<br>the upper and lower jaw<br>and for the functional and<br>esthetic oral rehabilitation<br>of edentulous and<br>partially edentulous<br>patients. BLX Implants<br>can be placed with<br>immediate function on<br>single-tooth applications<br>when good primary<br>stability is achieved and<br>with appropriate occlusal<br>loading to restore<br>chewing function. The<br>prosthetic restorations<br>are connected to the<br>implants through the<br>corresponding abutment<br>components. | TLX Implants are suitable<br>for endosteal implantation<br>in the upper and lower<br>jaws and for the functional<br>and esthetic oral<br>rehabilitation of<br>edentulous and partially<br>edentulous patients. TLX<br>Implants can be placed<br>with immediate function<br>on single-tooth and multi-<br>unit restorations when<br>good primary stability is<br>achieved and with<br>appropriate occlusal<br>loading to restore chewing<br>function. The prosthetic<br>restorations are<br>connected to the implants<br>through the corresponding<br>abutment components. | The Xpeed AnyRidge<br>Internal Implant System is<br>intended to be surgically<br>placed in the maxillary or<br>mandibular molar areas<br>for the purpose providing<br>prosthetic support for<br>dental restorations<br>(Crown, bridges, and<br>overdentures) in partially<br>or fully edentulous<br>individuals. It is used to<br>restore a patient's<br>chewing function. Smaller<br>implants (less than Ø6.0<br>mm) are dedicated for<br>immediate loading when<br>good primary stability is<br>achieved and with<br>appropriate occlusal<br>loading. Larger implants<br>are dedicated for the<br>molar region and are<br>indicated for delayed<br>loading. |
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE<br>DEVICE | REFERENCE DEVICE<br>(BLX IMPLANTS) | REFERENCE DEVICE<br>(TLX IMPLANTS) | REFERENCE DEVICE<br>(XPEED ANYRIDGE<br>IMPLANTS) |
| K Number | K212533 | K130222 | K173961 | K200586 | K140091 |
| Material | Titanium-13 Zirconium<br>alloy (Roxolid®) | Titanium-13 Zirconium<br>alloy (Roxolid®) | Titanium-13 Zirconium<br>alloy (Roxolid®) | Titanium-13 Zirconium<br>alloy (Roxolid®) | CP Ti Grade 4 |
| Surface<br>Treatment | Hydrophilic SLActive®<br>and SLA® | Hydrophilic SLActive® | Hydrophilic SLActive®<br>and SLA®<br>(SLA® introduce by<br>Memo-to-File) | Hydrophilic SLActive® | SLA® |
| Implant to<br>Abutment<br>Connection | TorcFit<br>(with conical fitting) | SynOcta and CrossFit | TorcFit<br>(with conical fitting) | TorcFit<br>(with conical fitting) | n/a |
| Implant<br>Diameter | Ø5.0, 5.5 and 6.5 mm | Ø3.3, Ø4.1, Ø4.8, and<br>Ø4.8 for TL (S, SP, TE)<br>Ø3.3, Ø4.1 and Ø4.8, BL | Ø 4.5, 5.5, 6.5 mm | Ø3.75, 4.0, 4.5, 5.0, 5.5,<br>and 6.5 mm | For normal ridge: 4.0,<br>4.4, 4.9, 5.4 & 5.9 mm<br>For low ridge: 6.4, 6.9,<br>7.4, 7.9 & 8.4 mm |
| Implant<br>Length | Ø5.0 mm:<br>18 mm<br>Ø5.5 and 6.5 mm:<br>14 and 16mm | 6.0, 8.0, 10.0, 12.0, 14.0<br>& 16.0 mm | Ø4.5 mm:<br>6, 8, 10, 12, 14, 16 and<br>18 mm<br>Ø5.5 and 6.5 mm:<br>6, 8, 10, 12 mm | Ø3.75, 4.0, 4.5, 5.0 mm:<br>6, 8, 10, 12, 14, 16 and 18<br>mm<br>Ø5.5 and 6.5 mm:<br>6, 8, 10, 12 mm | For normal ridge: 7.7,<br>9.2, 10.7, 12.2, 14.20 &<br>17.2 mm<br>For low ridge: 7.9, 9.4,<br>10.9, 12.4 & 14.4 mm |
| Implant<br>Design | Tapered body | Cylindrical | Tapered body | Tapered body | n/a |
| Sterilization<br>Method | Irradiation | Irradiation | Irradiation | Irradiation | Irradiation |
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# BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
510(k) Summary
Table 1 – Comparison of subject device versus primary predicate device
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# BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
### Performance Testing
#### Bench Testing
An assessment regarding 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 do not introduce a new worst case compared to the reference device device. Therefore, dynamic fatigue testing was leveraged from the reference device K173961.
Insertion tests were performed for the subject implants and proved that there is an adequate insertion torque in different bone classes when the implant is inserted according to the surgical procedure. Insertion torque results are equivalent to the primary predicate device.
#### Biocompatibility Testing
A biological assessment was 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. No new issues of biocompatibility are raised for the subject devices. Therefore, no additional biocompatibility testing was required.
#### Sterilization Validation and Packaging
The sterilization process for the subject implants 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. 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 identical to the packaging of the primary predicate devices. 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
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# BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
### 510(k) Summary
(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 BLX WB implants are substantially equivalent to the primary and reference devices.
