(108 days)
Straumann® dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments).
The subject devices represent a line extension of the previously cleared implants of the Straumann Dental Implant System. The subject devices represent a full line of Straumann implants having the Ti-13Zr alloy (Roxolid®) and the SLA grit blast and acid etch surface finish in the same diameters, lengths, emergence profiles and implant-to abutment interfaces as previously cleared implants in the Straumann Dental Implant System.
This document (K150938) describes the Straumann® Dental Implant System - Roxolid® SLA Implants, which are dental endosseous implants. The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to previously cleared devices. The key change is the use of a Titanium-13Zirconium alloy (Roxolid®) for the implants, compared to commercially pure Grade 4 Titanium in the predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for specific performance metrics in a tabular format. Instead, it relies on demonstrating that the new material change (Roxolid®) does not negatively impact the performance compared to the predicate devices which used commercially pure Grade 4 Titanium. The performance is assessed through various bench studies.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Equivalence: The Ti-13Zr alloy (Roxolid®) must be shown to be equivalent or superior to commercially pure Grade 4 Titanium for dental implant applications. | The subject devices are made from Ti-13Zr alloy (Roxolid®), which has been previously reviewed and cleared in K111357, K081419, K083550, K121131, and K122855. This implies its biocompatibility and suitability are accepted. Technological characteristics (connections, diameters, lengths, surface finish) are identical to predicate devices. |
| Dynamic Fatigue Performance: The new material implant system must meet established dynamic fatigue standards for endosseous dental implants. | Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced in support of this submission. (Specific acceptance values are not provided in this summary, but the stated consistency with ISO 14801 implies meeting its criteria). |
| Transfer Piece Removal Force: The force required to remove the transfer piece must be within acceptable limits. | Transfer Piece removal force data has been provided. (Specific data and acceptance limits are not provided in this summary, but the provision of data implies it met acceptable levels). |
| Surface Finish Characteristics: The SLA surface finish must be consistent with prior cleared devices. | Surface finish characteristics and surface chemistry analysis data have also been provided. The documents state the SLA surface finish remains the same as the predicate devices. |
| Sterilization Efficacy: The sterilization method must achieve the required sterility assurance level. | Gamma Irradiation, 25 kGy min., validated per ISO 11137-1 and ISO 11137-2 to an SAL of $1 \times 10^{-6}$. This is identical to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states that the substantial equivalence of the device is addressed via "bench studies" and "dynamic fatigue test data consistent with FDA guidance and ISO 14801." However, it does not provide specific sample sizes (e.g., number of implants tested), the exact test parameters beyond "ISO 14801," or the provenance of the data (country of origin, retrospective/prospective). This information would typically be detailed in the full test reports, which are not included in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a medical device approval based on bench testing and material equivalence, not on clinical performance or interpretation of images by experts. Therefore, the concept of "experts used to establish the ground truth" for a test set (like in a diagnostic AI study) is not applicable here. The "ground truth" for the bench tests would be the results obtained following the specified standards (e.g., force values, cycles to failure).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this submission relies on bench testing and material characterization, not human interpretation or adjudication of outputs.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic tool. It is a dental implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance relies on engineering standards and scientific verification of material properties and mechanical performance. This includes:
- Material composition analysis: Verifying the Ti-13Zr alloy (Roxolid®) composition.
- Mechanical testing: Dynamic fatigue testing according to ISO 14801.
- Surface characterization: Analysis of the SLA grit blast and acid etch surface finish characteristics and surface chemistry.
- Sterilization validation: Conformance to ISO 11137-1 and ISO 11137-2 for sterility assurance level (SAL).
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this traditional medical device approval process. The device's performance is not learned through data like an AI model; it's designed and verified through engineering principles and testing.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24,2015
Straumann USA, LLC Christopher Klaczyk Director of Regulatory and Clinical Affairs 60 Minuteman Road Andover, Massachusetts 01810
Re: K150938
Trade/Device Name: Straumann® Dental Implant System - Roxolid® SLA Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: June 19, 2015 Received: June 22, 2015
Dear Mr. Klaczyk:
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.
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
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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 devicerelated 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Russo, DDS, MA
Erin I. Keith, M.S. 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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Indications for Use
510(k) Number (if known) K150938
Device Name
Straumann® Dental Implant System - Roxolid® SLA Implants
Indications for Use (Describe)
Straumann® dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments).
Type of Use (Select one or both, as applicable)
|× Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(k) Summary – K150938
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052 |
|---|---|
| Contact Person: | Christopher KlaczykDirector of Regulatory and Clinical Affairs |
| Date Prepared: | July 13, 2015 |
| Product Code(s): | DZE (21 CFR 872.3640) |
| Device Class: | II(21 CFR 872.3640) |
| Classification Panel: | Dental |
| Classification Name: | Endosseous dental implant (21 CFR 872.3640) |
| Proprietary Name: | Straumann® Dental Implant System ">– Roxolid® SLA Implants |
| Predicate Device(s) | This is a bundled 510(k) Premarket Notification. Each of thepredicates listed below is a primary predicate for a portion ofthe subject devices of this submission.K983742 - All in One Two Part Implant (Straumann)K012757 - Tapered Implant Modification (Straumann)K033922 - Standard Plus Implant (Straumann)K062129 - Bone Level Implants (Straumann)K111357 – NNC Roxolid Implant SystemK140878 - Bone Level Tapered Implants |
| Reference Device(s) | K033984 - SLActive Surface FinishK081419 - Roxolid Tapered Effect Implants (Straumann)K083550 - Roxolid 3.3 Implants (Straumann)K121131 – Roxolid 4.1/4.8 Bone Level Implants (Straumann)K122855 - Roxolid 4.1/4.8 Tissue Level Implants (Straumann) |
| Device Description: | The subject devices represent a line extension of the previouslycleared implants of the Straumann Dental Implant System. Thesubject devices represent a full line of Straumann implantshaving the Ti-13Zr alloy (Roxolid®) and the SLA grit blast andacid etch surface finish in the same diameters, lengths,emergence profiles and implant-to abutment interfaces aspreviously cleared implants in the Straumann Dental ImplantSystem. |
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Straumann® dental implants are indicated for oral endosteal Intended Use: implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments).
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Materials: The subject devices will be produced from a titanium-13zirconium alloy, trade named Roxolid®, as previously reviewed and cleared to market per premarket notification submissions K111357 for the predicate devices, as well as K081419, K083550, K121131 and K122855 for the reference devices.
The transfer piece is produced from titanium-6aluminum-7niobium alloy (TAN) conforming to ISO 5832-11. This is the same material and design as for the predicate transfer pieces cleared to market per premarket notification submissions K140878. -
The subject devices have the same Indications For Use and the Technological Characteristics: same technical characteristics as the identified predicate and reference devices, with the exception of the material. Technological characteristics of the subject devices are compared with those of the predicate devices in the table below.
| Feature | Subject DevicesRoxolid SLA Implants | Predicate DevicesTitanium SLA Implants |
|---|---|---|
| Implant-to-AbutmentConnections:Bone Level | Narrow CrossFit (NC) | Narrow CrossFit (NC) |
| Regular CrossFit (RC) | Regular CrossFit (RC) | |
| Implant-to-AbutmentConnections:Tissue Level | Narrow Neck CrossFit® (NNC) | Narrow Neck CrossFit® (NNC) |
| Regular Neck (RN) | Regular Neck (RN) | |
| Wide Neck (WN) | Wide Neck (WN) | |
| Implant Diameter(s) | Ø3.3mm, Ø4.1mm, Ø4.8mm | Ø3.3mm, Ø4.1mm, Ø4.8mm |
| Implant Length(s) | 6.0, 8.0, 10.0, 12.0, 14.0, 16.0 mm(6.0mm length excluded for Ø3.3mm) | 6.0, 8.0, 10.0, 12.0, 14.0, 16.0 mm(6.0mm length excluded for Ø3.3mm) |
| Surface Finish | SLA | SLA |
| Material | Commercially pure Grade 4Titanium | Titanium-13Zirconium alloy(Roxolid®) |
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| Primary Package | Vial of styrene-butadiene block copolymer (Styrolux), vial cap of LDPE and an implant holder of Grilamid TR70 polyamide. | Vial of styrene-butadiene block copolymer (Styrolux), vial cap of LDPE and an implant holder of Grilamid TR70 polyamide. |
|---|---|---|
| Sterilization | Gamma Irradiation, 25 kGy min.Validated per ISO 11137-1 and ISO 11137-2 to an SAL of $1 x 10^{-6}$ | Gamma Irradiation, 25 kGy min.Validated per ISO 11137-1 and ISO 11137-2 to an SAL of $1 x 10^{-6}$ |
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. Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced in support of this submission. Transfer Piece removal force data has been provided. Surface finish characteristics and surface chemistry analysis data have also been provided.
- 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.
§ 872.3640 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.