Straumann Variobase Abutments XC for Bridge/Bar

K253315 · Institut Straumann AG · NHA · Jan 22, 2026 · Dental

Device Facts

Record IDK253315
Device NameStraumann Variobase Abutments XC for Bridge/Bar
ApplicantInstitut Straumann AG
Product CodeNHA · Dental
Decision DateJan 22, 2026
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3630
Device ClassClass 2

Intended Use

Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations.

Device Story

Straumann Variobase Abutments XC are prosthetic components connecting Straumann dental implants to customized bridge/bar restorations. Devices are non-engaging, manufactured from Ti-6Al-7Nb (TAN) alloy, and feature a laser-texturized chimney surface to enhance cement retention. Available in multiple platform diameters (RB/WB, WB) and gingival heights, with straight or angled screw channel options. Used in dental clinics by clinicians; the abutment is screwed into the implant, and the prosthetic restoration is cemented onto the abutment chimney. Temporary restorations are used during the healing phase to shape soft tissue. The device provides a stable foundation for multi-unit restorations, facilitating functional and aesthetic rehabilitation for patients with missing teeth.

Clinical Evidence

Bench testing only. Performance evaluated via dynamic fatigue testing, pull-off force testing to validate cement retention on the laser-texturized surface, and SEM/EDX surface analysis. Biocompatibility assessed per ISO 10993-1. No clinical data provided.

Technological Characteristics

Material: Ti-6Al-7Nb (TAN) alloy. Surface: Partially anodized (violet) with laser-texturized chimney. Connection: TorcFit (non-engaging). Sterilization: Non-sterile, validated for end-user steam sterilization (autoclave). Dimensions: Platform diameters 3.8/4.5/5.5 mm; gingival heights 0.75/1.5/2.5/3.5 mm; chimney height 7 mm (customizable to 3.5 mm).

Indications for Use

Indicated for patients requiring screw-retained or cement-retained bridge restorations supported by Straumann dental implants. Temporary restorations may be used to maintain, stabilize, and shape soft tissue during healing, provided they are placed out of occlusion. Final abutments and restorations may be placed in occlusion once the implant is fully osseointegrated.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION January 22, 2026 Institut Straumann AG % Jennifer Jackson Sr. Director, Regulatory Affairs and Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810 Re: K253315 Trade/Device Name: Straumann Variobase Abutments XC for Bridge/Bar Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 29, 2025 Received: December 23, 2025 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 (the 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 available 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253315 - Jennifer Jackson Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. {2} K253315 - Jennifer Jackson Page 3 For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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 -S 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 Quality Center for Devices and Radiological Health Enclosure {3} FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K253315 | | | Device Name | | | Straumann Variobase Abutments XC for Bridge/Bar | | | Indications for Use (Describe) | | | The Straumann Variobase Abutments XC for Bridge/Bar are prosthetic components placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann Variobase Abutments XC for Bridge/Bar are indicated for screw-retained or cement-retained bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize, and shape the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. Final abutments and restorations may be placed in occlusion when the implant is fully osseointegrated. | | | 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) | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {4} Traditional 510(k) Submission Straumann Variobase Abutments XC for Bridge/Bar 510(k) Summary – K253315 # 510(k) Summary ## Submitter’s Contact Information Submitter: Straumann USA, LLC 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 and Quality Phone Number: +1-978-747-2509 Fax Number: +1-978-747-0023 Prepared By & Alternate Contact: Olivier Russo Associate Director Regulatory Affairs Institut Straumann AG Phone number: +41 61 965 1260 Date of Submission: January 21, 2026 ## Name of the Device Trade Names: Straumann Variobase Abutments XC for Bridge/Bar Common Name: Straumann Variobase Abutments XC for Bridge/Bar Classification Name: Endosseous dental implant abutment Regulation Number: 21 CFR 872.3630 Device Classification: II Product Code(s): NHA Secondary Product Code: n/a Review Panel: Dental Proprietary Name: Straumann Variobase Abutments XC for Bridge/Bar Institut Straumann AG January 21, 2026 {5} Traditional 510(k) Submission Straumann Variobase Abutments XC for Bridge/Bar 510(k) Summary – K253315 # Predicate Device(s) ## Primary Predicate: - K190040 - Straumann® BLX Variobase Abutments for Bar and Bridges ## Reference Devices: - K190662 - MRI Compatibility for Existing Straumann Dental Implant Systems - K230108 - Straumann® BLC and TLC Implants # Device Description Straumann Variobase Abutments XC for Bars and Bridges are intended to be placed into Straumann implants to provide support for multi-unit restorations. The prosthetic restoration (bar/bridge) must be cemented onto the Variobase abutments, which is then screwed onto the implants. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. The subject Variobase abutments are manufactured from Ti-6Al-7Nb (TAN) and are anodized in violet. The Variobase Abutments for bar/bridges are non-engaging devices intended to support multiple-unit restorations. The Variobase abutments are provided non-sterile with instructions for end user steam sterilization. The Variobase abutments are fixed in the implant by means of a basal screw which is also manufactured from Ti-6Al-7Nb (TAN). The subject Straumann Variobase Abutments XC for Bridge/Bar is provided in two different platform models, both available with straight and angled screw channel solutions: Institut Straumann AG January 21, 2026 {6} Traditional 510(k) Submission Straumann Variobase Abutments XC for Bridge/Bar 510(k) Summary – K253315 Table 10.4.a - Straumann Variobase Abutments XC for Bridge/Bar characteristics | Platform | Ø (mm) | Gingival heights (mm) | Chimney height (mm) | | --- | --- | --- | --- | | RB/WB | 3.8 / 4.5 | 1.5 / 2.5 / 3.5 | 7 | | WB | 5.5 | 0.75 / 1.5 | 7 | ## Intended Use Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. ## Indications for Use The Straumann Variobase Abutments XC for Bridge/Bar are prosthetic components placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann Variobase Abutments XC for Bridge/Bar are indicated for screw-retained or cement-retained bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize, and shape the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. Final abutments and restorations may be placed in occlusion when the implant is fully osseointegrated. ## Technological Characteristics The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following table: Institut Straumann AG January 21, 2026 {7} Traditional 510(k) Submission Straumann Variobase Abutments XC for Bridge/Bar 510(k) Summary – K253315 Table 10.7.a - Technological Characteristics | FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | EQUIVALENCE DISCUSSION | | --- | --- | --- | --- | | K Number | K253315 - Straumann Variobase Abutments XC for Bridge/Bar | K190040 - Straumann® BLX Variobase Abutments for Bar and Bridges | K190040- BLX Variobase Abutments AS for Crown | | Indications for Use | The Straumann Variobase Abutments XC for Bridge/Bar are prosthetic components placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann Variobase Abutments XC for Bridge/Bar are indicated for screw-retained or cement-retained bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize, and shape the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. Final abutments and restorations may be placed in occlusion when the implant is fully osseointegrated. | Straumann® Variobase™ prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (bridge or overdenture) can be cemented on the Straumann® Variobase™ prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. | The Straumann® Variobase® for Crown AS is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann Variobase for Crown AS are indicated for screw retained single tooth or cement retained single tooth and bridge restorations. A temporary restoration can be used prior to insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. All digitally designed copings and/or crowns for use with the Straumann® Variobase® for Crown AS are intended to be sent to Straumann for manufacture at a validated milling center. | | Implant to Abutment Connection | TorcFit connection New RB/WB Interface (Flat top with internal guidance within the conical interface) New WB Interface (implant shoulder with internal guidance within the conical interface) Non-engaging design | TorcFit connection RB/WB Interface (sitting on implant shoulder) WB Interface (sitting on implant shoulder) Non-engaging design | TorcFit connection RB/WB Interface (sitting on implant shoulder) WB Interface (sitting on implant shoulder) Engaging design | | Abutment Material | Titanium alloy (Ti-6Al-7Nb, TAN) | Titanium alloy (Ti-6Al-7Nb, TAN) | Titanium alloy (Ti-6Al-7Nb, TAN) | | Restoration Types Supported | Bridges and bars | Bridges and bars | Crowns | | Compatible Implants | Straumann Bone Level implants having RB/WB and WB implant-to-abutment interface geometries BLX and BLC implant systems: • BLX implant diameters : 3.5 / 3.75 / 4 / 4.5 / 5 / 5.5 / 6.5 • BLC implant diameters : 3.3 / 3.7 / 4 / 4.5 / 5 / 5.5 / 6.5 | Straumann Bone Level BLX implants having RB/WB implant-to-abutment interface geometries | Straumann Bone Level BLX implants having RB/WB implant-to-abutment interface geometries | | Maximum Angulation | 30° controlled in design software | 30° controlled in design software | 30° controlled in design software | | Gingiva height | RB/WB Interface: 1.5 / 2.5 / 3.5 mm WB Interface: 0.75 / 1.5 mm | RB/WB Interface: 1.5 mm WB Interface: 1.5 mm | RB/WB Interface: 1.5 mm WB Interface: 1.5 mm | Institut Straumann AG January 21, 2026 {8} Traditional 510(k) Submission Straumann Variobase Abutments XC for Bridge/Bar 510(k) Summary – K253315 | FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | | EQUIVALENCE DISCUSSION | | --- | --- | --- | --- | --- | | K Number | K253315 - Straumann Variobase Abutments XC for Bridge/Bar | K190040 - Straumann® BLX Variobase Abutments for Bar and Bridges | K190040- BLX Variobase Abutments AS for Crown | | | Variobase Abutment Chimney Height | 7 mm (can be reduced to minimum 3.5 mm) Note: the abutment post height is customizable. Adaptable levels are visually identifiable on the chimney section via grooves and spaced 1 mm apart, starting from the maximum height of the Variobase abutment | 5.5 mm (can be reduced to 3.5 mm) | 5.5mm | Equivalent to the primary predicate device. The new Variobase XC portfolio offers more flexibility at the chimney height. | | Variobase platform diameter range | RB, WB Interface: 3.8 / 4.5 mm WB Interface: 5.5 mm | 4.5 mm | Ø 4.5mm and 5.5mm | Identical to the primary predicate | | Screw Channel | Straight and Angled screw channel | Straight screw channel | Angled screw channel solutions | Identical to the primary predicate | | Surface | Partially anodized Roughened and structured chimney surface (laser-texturized) | Partially anodized | Partially anodized | Identical to the primary predicate for the anodized surface. Roughened surface enhancing cement retention compared to currently available Variobase abutments was evaluated through biocompatibility testing and pull-off testing. These assessments support the demonstration of substantial equivalence to the predicate device. SEM/EDX analysis was performed to evaluate the surface characteristics. | | Sterility | Provided non-sterile – terminally sterilized via autoclave prior to implantation. | Provided non-sterile – terminally sterilized via autoclave prior to implantation. | Provided non-sterile – terminally sterilized via autoclave prior to implantation. | Identical to the primary predicate | Institut Straumann AG January 21, 2026 {9} Traditional 510(k) Submission Straumann Variobase Abutments XC for Bridge/Bar 510(k) Summary – K253315 # Performance Testing ## Sterilization Validation and Shelf Life The Straumann Variobase Abutments XC for Bridge/Bar subject devices are provided non-sterile and need to be sterilized by moist heat (steam) after milling into the patient-specific shape by the end-user. The recommended sterilization method has been validated according to ISO 17665-1 and applicable recommendations in the FDA guidance document “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015”. The sterilization methods and parameters are equivalent to the primary predicate and reference devices. ## Biocompatibility Testing Biological assessment has been performed according to ISO 10993-1 “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 are equivalent in material and manufacturing processes to the primary predicate and reference devices, therefore, no new issues regarding biocompatibility were raised. ## Electromagnetic Compatibility There are no significant changes to the materials and dimensions from the currently marketed predicate devices. Therefore, no new issues of electromagnetic compatibility are raised for the subject devices, and they can be considered MR Conditional. K190662 - MRI Compatibility for Existing Straumann Dental Implant Systems was referenced for MRI testing and labelling. Institut Straumann AG January 21, 2026 {10} Institut Straumann AG January 21, 2026 5 # Traditional 510(k) Submission ## Straumann Variobase Abutments XC for Bridge/Bar 510(k) Summary – K253315 ## Performance Testing – Bench ### Dynamic Fatigue The device design and performance testing submitted or referenced in support of this premarket notification 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 are representative of the design and performance of the subject devices. ### Pull-off Testing The Straumann Variobase Abutments XC for Bridge/Bar feature a roughened and structured chimney surface, which improves cement retention compared to the machined surface of current Variobase abutments. The effectiveness of this surface was evaluated by measuring the pull-off force required to separate the coping from the abutment after cementation. A worst-case approach was applied to define the testing setup. The selection criteria focused on the abutment design, particularly the surface and geometry of the abutment post height, as cement is applied to this region. The minimum post height of 3.5 mm was chosen as the worst-case scenario, since it allows the least amount of cement and therefore represents the most challenging condition for adhesion. Results demonstrate that the lasered-surface abutments generate higher pull-off force than machined surface abutments, confirming the enhanced cement retention of the new textured surface. ### Surface Analysis The new roughened and structured chimney surface of the Straumann Variobase Abutments XC for Bridge/Bar was analyzed using SEM-EDX. Images demonstrate that the laser-texturized chimney exhibit altered surface topography compared to the machined surface, while retaining an equivalent elemental composition consistent with Ti-6Al-7Nb material. {11} Institut Straumann AG January 21, 2026 6 # Traditional 510(k) Submission Straumann Variobase Abutments XC for Bridge/Bar 510(k) Summary – K253315 ## Conclusion The conclusion drawn from the nonclinical tests submitted in this premarket notification demonstrates that the Straumann Variobase Abutments XC for Bridge/Bar are substantially equivalent to the primary predicate device.
Innolitics
510(k) Summary
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