(200 days)
Straumann® Variobase™ for Bridge/Bar Cylindrical prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The patient-specific prosthetic restoration (bridge or over-denture) can be cemented on the Straumann® Variobase™ for Bridge/Bar Cylindrical 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. Temporary restorations are indicated to be placed out of occlusion. Straumann® Variobase™ for Bridge/Bar Cylindrical and patient-specific restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed Straumann® Variobase® for Bridge/Bar Cylindrical prosthetic components are intended to be sent to Straumann for manufacture at a validated milling center.
The Straumann® Variobase™ for Bridge/Bar Cylindrical, see Figure 1 and Table 1, are non-engaging (without rotational lock) abutments made from Ti-6Al-7Nb (TAN) that support a bridge or bar reconstruction (framework or full contour) on two or more dental implants. The corresponding basal screw is delivered with the abutment for connecting the abutment to the implant. A dental laboratory technician designs and manufactures the bridge/bar reconstruction via their preferred workflow using traditional or CAD/CAM methods.
This document is a 510(k) premarket notification for a medical device called "Straumann® Variobase™ for Bridge/Bar Cylindrical". It does not describe a study that uses software, AI, or machine learning. Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies as these concepts are not applicable to the provided document.
The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and bench testing (dynamic fatigue, software validation, sterilization validation, and biocompatibility testing) for a dental implant abutment. The "Software validation conforming to the requirements of IEC 62304" mentioned in the Performance Data section refers to the validation of software used in the manufacture of the device (specifically, for digitally designed components intended to be sent to a validated milling center), not a clinical performance or diagnostic AI component of the device itself.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 17, 2018
Institut Straumann AG Jennifer Jackson Director, Regulatory Affairs and Quality 60 Minuteman Road Andover, Massachusetts 01810
Re: K173968
Trade/Device Name: Straumann® Variobase™ for Bridge/Bar Cylindrical Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 14, 2018 Received: June 18, 2018
Dear Jennifer Jackson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Straumann® Variobase™ for Bridge/Bar Cylindrical
Indications for Use (Describe)
Straumann® Variobase™ for Bridge/Bar Cylindrical prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The patientspecific prosthetic restoration (bridge or over-denture) can be cemented on the Straumann® Variobase™ for Bridge/Bar Cylindrical 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. Temporary restorations are indicated to be placed out of occlusion. Straumann® Variobase™ for Bridge/Bar Cylindrical and patient-specific restorations may be placed into occlusion when the implant is fully osseointegrated.
All digitally designed Straumann® Variobase® for Bridge/Bar Cylindrical prosthetic components are intended to be sent to Straumann for manufacture at a validated milling center.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
| | Over-The-Counter Use (21 CFR 801
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FORM FDA 3881 (8/14)Equivalent
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510(k) Summary
| Submitter's Contact Information | |
|---|---|
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315Owner/Operator No.: 9005052 |
| Contact Person: | Jennifer JacksonDirector, Regulatory Affairs & Quality |
| Prepared By: | Dr. Gordon DoddsManager Design Control QMEtkon GmbH |
| Date Prepared: | July 16, 2018 |
| Product Code(s): | NHA (21 CFR 872.3630) |
| Device Class: | II (21 CFR 872.3630) |
| Classification Panel: | Dental |
| Name of the Device | |
| Classification Name: | Endosseous dental implant abutment (21 CFR 872.3630) |
| Proprietary Name: | Straumann® Variobase™ for Bridge/Bar Cylindrical |
| Predicate Device(s): | |
| Predicate Device(s): | K151157 Straumann Variobase for Bridge/Bar K142890 Straumann Variobase Abutments K120822 Straumann CARES Variobase AbutmentNNC, RN, WN, NC, RC K132844 Straumann CARES Bone Level ScrewRetained Bars, Straumann CARES Bone LevelScrew Retained Bridges |
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- K041295 RN Synocta UCLA Gold Abutment for . the Straumann Dental Implant
Device Description
The Straumann® Variobase™ for Bridge/Bar Cylindrical, see Figure 1 and Table 1, are non-engaging (without rotational lock) abutments made from Ti-6Al-7Nb (TAN) that support a bridge or bar reconstruction (framework or full contour) on two or more dental implants. The corresponding basal screw is delivered with the abutment for connecting the abutment to the implant. A dental laboratory technician designs and manufactures the bridge/bar reconstruction via their preferred workflow using traditional or CAD/CAM methods.
Image /page/4/Picture/4 description: The image shows five dental implant abutments labeled NC, RC, NNC, RN, and WN. The abutments are all silver in color, except for the NC abutment, which has a gold-colored base. The abutments are all different shapes and sizes, with the NC abutment being the smallest and the WN abutment being the largest. The abutments are used to connect dental implants to crowns or other dental prosthetics.
Figure 1 Straumann Variobase for Bridge/Bar Cylindrical
Table 1 - Listing of devices
| Device Name | Device Number |
|---|---|
| Straumann® NC Variobase™ for Bridge/BarCylindrical | 022.0110 / 010.6085 |
| Straumann® RC Variobase™ for Bridge/BarCylindrical | 022.0111 / 010.6086 |
| Straumann® RN Variobase™ for Bridge/BarCylindrical | 048.378 / 010.6083 |
| Straumann® WN Variobase™ for Bridge/BarCylindrical | 048.379 / 010.6084 |
| Straumann® NNC Variobase™ for Bridge/BarCylindrical | 048.377 / 010.6082 |
Intended Use:
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Straumann® Variobase™ for Bridge/Bar Cylindrical are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as bridges and over-dentures
Indications For Use
Straumann® Variobase™ for Bridge/Bar Cylindrical prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The patient-specific prosthetic restoration (bridge or overdenture) can be cemented on the Straumann® Variobase™ for Bridge/Bar Cylindrical 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. Temporary restorations are indicated to be placed out of occlusion. Straumann® Variobase™ for Bridge/Bar Cylindrical and patient-specific restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed Straumann® Variobase® for Bridge/Bar Cylindrical prosthetic components are intended to be sent to Straumann for manufacture at a validated milling center.
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Technological Chracteristics
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following table.
Table 2: Substantial Equivalence Comparison
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| FEATURE | Subject DeviceStraumann® Variobase™ for Bridge/BarCylindricalSubject Submission | Predicate DeviceStraumann® Variobase™Abutments for Bridge/Bar(K151157) | Reference PredicateDevicesStraumann® Variobase™Abutments(K120822, K142890)Straumann® Screws(K132844, K041295) | EquivalenceDiscussion |
|---|---|---|---|---|
| Indications forUse | Straumann® Variobase™ for Bridge/BarCylindrical prosthetic components directlyconnected to the endosseous dental implantsare indicated for use as an aid in prostheticrehabilitations. The patient-specific prostheticrestoration (bridge or over-denture) can becemented on the Straumann® Variobase™ forBridge/Bar Cylindrical prosthetic components.A temporary restoration can be used prior tothe insertion of the final components tomaintain, stabilize and form the soft tissueduring the healing phase. Temporaryrestorations are indicated to be placed out ofocclusion. Straumann® Variobase™ forBridge/Bar Cylindrical and patient-specificrestorations may be placed into occlusionwhen the implant is fully osseointegrated.All digitally designed Straumann®Variobase® for Bridge/Bar Cylindricalprosthetic components are intended to besent to Straumann for manufacture at avalidated milling center. | Straumann® Variobase® prostheticcomponents directly or indirectlyconnected to the endosseous dentalimplant are intended for use as an aidin prosthetic rehabilitations. Theprosthetic restoration (bridge oroverdenture) can be cemented on theStraumann® Variobase® prostheticcomponents. A temporary restorationcan be used prior to the insertion ofthe final components to maintain,stabilize and form the soft tissueduring the healing phase. They maynot be placed into occlusion. Finalabutments and restorations may beplaced into occlusion when theimplant is fully osseointegrated. | Not applicable | IdenticalSection regardingproduction methods hasbeen added. The sameproduction methods areused for the predicatedevice. |
| AbutmentMaterial | Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb) | Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb) | Not applicable | Identical |
| FEATURE | Subject DeviceStraumann® Variobase™ for Bridge/BarCylindricalSubject Submission | Predicate DeviceStraumann® Variobase™Abutments for Bridge/Bar(K151157) | Reference PredicateDevicesStraumann® Variobase™Abutments(K120822, K142890)Straumann® Screws(K132844, K041295) | EquivalenceDiscussion |
| AbutmentDiameter | 4.5 – 7.0 mm | 4.2 – 7.0 mm | Not applicable | EquivalentThe subject device NCinterface is 0.3 mm widerand gives more support |
| AbutmentHeight | 3.5 – 4.5 mm | 3.5 – 4.5 mm | Not applicable | Identical |
| AbutmentApicalDesign | Non-engaging (no rotational lock) Morse taper | Non-engaging (no rotational lock)Morse taper | Not applicable | Identical |
| AbutmentCoronalDesign | Straight wall with detents | 10° or15° conical taper | K120822, K142890 -Straight wall with detents | EquivalentThe coronal design isidentical to the referencepredicate devices and hasthe equivalent function asthe predicate devices. |
| Basal ScrewDesign | NC/RC Conical Head Screw Bone LevelRN/WN Conical Head Screw Tissue Level | K132844, K041295 -NC/RC Conical Head ScrewBone LevelRN/WN Conical HeadScrew Tissue Level | Identical | |
| FEATURE | Subject DeviceStraumann® Variobase™ for Bridge/BarCylindricalSubject Submission | Predicate DeviceStraumann® Variobase™Abutments for Bridge/Bar(K151157) | Reference PredicateDevicesStraumann® Variobase™Abutments(K120822, K142890)Straumann® Screws(K132844, K041295) | EquivalenceDiscussion |
| RestorationTypesSupported | Patient-specific prosthetic bridge or over-denture | Patient-specific prosthetic bridge orover-denture | Not applicable | Identical |
| RestorationMaterial | Materials cleared by the FDA under 21 CFR872.6660 or exempt materials as describedunder 21 CFR 872.3060 (Noble metal alloys)and 21 CFR 872.3710 (Base metal alloys) | Materials cleared by the FDA under21 CFR 872.6660 or exemptmaterials as described under 21 CFR872.3060 (Noble metal alloys) and 21CFR 872.3710 (Base metal alloys) | Not applicable | Identical |
| DesignWorkflow | Wax-up or CAD | Wax-up or CAD | Not applicable | Identical |
| ManufacturingWorkflow | Traditional casting or Straumann Milling Center | Traditional casting, pressing orStraumann Milling Center | Not applicable | Identical |
| MechanicalStability | Dynamic fatigue testPass | Dynamic fatigue testPass | Not applicable | Identical |
| Sterilization | Steam autoclave | Steam autoclave | Not applicable | Identical |
| FEATURE | Subject DeviceStraumann® Variobase™ for Bridge/BarCylindricalSubject Submission | Predicate DeviceStraumann® Variobase™Abutments for Bridge/Bar(K151157) | Reference PredicateDevicesStraumann® Variobase™Abutments(K120822, K142890)Straumann® Screws(K132844, K041295) | EquivalenceDiscussion |
| Mode of Action | Screw-retained or cement retained | Screw-retained or cement retained | Not applicable | Identical |
| Reusable | No | No | Not applicable | Identical |
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Performance Data
Per Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments dated May 12, 2004, the substantial equivalence of the subject device(s) are satisfactorily addressed via bench studies.
The following testing has been conducted or substantial equivalence to tested predicate devices has been demonstrated:
- Dynamic fatigue testing conforming to FDA guidance and ISO 14801. ●
- . Software validation conforming to the requirements of IEC 62304.
- . Sterilization validation conforming to ISO 17665-1 and ISO/TS 17665-2 (K151157 Straumann Variobase for Bridge/Bar).
- Biocompatibility testing conforming to ISO-10993-1 (K120822 Straumann CARES . Variobase Abutment NNC, RN, WN, NC, RC)
Conclusions
Based upon our assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate devices.
§ 872.3630 Endosseous dental implant abutment.
(a)
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.(b)
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.)