(84 days)
Straumann® Bone Level Tapered 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 Bone Level Tapered 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 Bone Level Tapered Implants of the Straumann Dental Implant System (K140878 and K150938). The subject devices have the same diameters (3.3, 4.1 and 4.8 mm), the same implant-to-abutment interfaces (NC, RC), the same material (Ti-13Zr) and the same surface finishes (SLA, SLActive) as the identified primary predicate devices. The subject devices differ in that the lengths are 18 mm versus a maximum length for the primary predicate devices of 16 mm.
This document describes the Straumann® Bone Level Tapered Implants, a line extension of existing dental implants. The new implants are identical to previously cleared devices except for an increased length (18mm vs. previous maximum of 16mm).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the new 18mm implant length in a quantitative format as would typically be seen for AI/ML device performance. Instead, it relies on comparison to predicate devices and performance of specific bench tests. The primary acceptance criteria for the new device appear to be:
- Substantial Equivalence: The subject device is substantially equivalent to the identified predicate devices in terms of indications for use, technological characteristics (except length), and performance.
- Safety and Effectiveness through Bench Studies: The device must satisfactorily address safety and effectiveness through relevant bench studies, particularly dynamic fatigue, biological compatibility, sterilization validation, and shelf life, consistent with FDA guidance and ISO standards.
- No New Failure Modes: The new, longer implants, especially the smallest diameter (3.3mm), must not introduce new failure modes compared to predicate or reference devices when tested under simulated clinical conditions.
| Acceptance Criterion | Reported Device Performance/Findings |
|---|---|
| Substantial Equivalence to Predicate Devices (K140878, K150938) | The subject devices are stated to be "identical in every respect to the identified Bone Level Tapered predicate devices with the exception of overall length". |
| Dynamic Fatigue Test (consistent with FDA guidance and ISO 14801) | Incorporated by reference to primary predicate (K140878). Implies the predicate met this, and by extension, the new device, being identical except length, is considered to meet it. |
| Biological Compatibility (per ISO 10993 series standards) | Incorporated by reference to primary predicate (K140878). Implies the predicate met this, and by extension, the new device, using the same materials, is considered to meet it. |
| Sterilization Validation (per ISO 11137 series standards) | Incorporated by reference to primary predicate (K140878). Implies the predicate met this. |
| Shelf Life (stability) (per ASTM F1980) | Incorporated by reference to primary predicate (K140878). Implies the predicate met this. |
| No new failure modes due to reduced minimum implant diameter (Ø3.3 mm vs. Neodent CM Drive Ø3.5 mm) - specifically for peak insertion torque while driving implants into simulated bone. | Peak insertion torque was measured on all three diameters (3.3, 4.1, 4.8 mm) of the subject device in polyurethane foam of varying densities. The conclusion states that based on the assessment of design and performance data, the devices are substantially equivalent. This implies no new failure modes were identified. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a number of devices or clinical cases. The "test set" here refers to the samples used in the bench studies.
- For the peak insertion torque study: "all three diameters of the subject device" were tested. It is not specified how many samples per diameter were tested.
- For the studies incorporated by reference (dynamic fatigue, biological compatibility, sterilization, shelf life), the sample sizes are not provided in this document but would have been part of the K140878 submission.
- Data Provenance: Bench studies. There is no indication of human clinical data or geographical origin for this specific submission, as it focuses on extended length and comparison to predicates through bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this submission. The "ground truth" for these types of mechanical and biological tests is derived from standardized testing methods and material properties, not expert clinical interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are relevant for studies involving human reviewers or subjective interpretations. The studies described are objective bench tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
Not applicable. This device is a physical dental implant, not an AI/ML-driven diagnostic or assistive software. Therefore, no MRMC or AI-related studies were performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is not an AI/ML device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance claims in this submission is established through:
- Standardized Bench Testing: Adherence to international standards (e.g., ISO 14801, ISO 10993, ISO 11137, ASTM F1980) for mechanical strength, biocompatibility, sterilization, and stability.
- Material Specifications: Properties of the Roxolid® (Ti-13Zr) alloy and other materials.
- Clinical Experience/Predicate Devices: The established safety and effectiveness of the existing Straumann® Bone Level Tapered Implants and reference devices.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/ML device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 23, 2016
Institut Straumann AG c/o Ms. Jennifer Jackson. M.S. Head of Regulatory Affairs and Quality Straumann USA. Inc. 60 Minuteman Road Andover, Massachusetts 01810
Re: K153758
Trade/Device Name: Straumann® Bone Level Tapered Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 29, 2015 Received: December 30, 2015
Dear Ms. 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 (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,
Tina Kiang -S
for 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) K153758
Device Name
Straumann® Bone Level Tapered Implants
Indications for Use (Describe)
Straumann® Bone Level Tapered 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 Bone Level Tapered 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 | K153758 |
|---|---|---|
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052 | |
| Contact Person: | Jennifer Jackson, MSHead of Regulatory Affairs and Quality(978) 747-2509 | |
| Prepared By: | Christopher KlaczykHead of North American Regulatory Affairs+41 79 915 8367 | |
| Date Prepared: | March 7, 2016 | |
| 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® Bone Level Tapered Implant | |
| Predicate Device:: | Straumann Bone Level Tapered Implants (K140878) | |
| Reference Device(s): | Straumann Roxolid SLA Implants (K150938)Neodent CM Drive Line Extension (K150182) | |
| Device Description: | The subject devices represent a line extension of the previouslycleared Bone Level Tapered Implants of the Straumann DentalImplant System (K140878 and K150938). The subject deviceshave the same diameters (3.3, 4.1 and 4.8 mm), the sameimplant-to-abutment interfaces (NC, RC), the same material(Ti-13Zr) and the same surface finishes (SLA, SLActive) as theidentified primary predicate devices. The subject devices differin that the lengths are 18 mm versus a maximum length for theprimary predicate devices of 16 mm. | |
| Intended Use:Bone Level TaperedImplants | Straumann® Bone Level Tapered Implants are indicated for oralendosteal implantation in the upper and lower jaw and for thefunctional and esthetic oral rehabilitation of edentulous andpartially dentate patients. Straumann Bone Level TaperedImplants can also be used for immediate or early implantationfollowing extraction or loss of natural teeth. Implants can beplaced with immediate function on single-tooth and/or multipletooth applications when good primary stability is achieved andwith appropriate occlusal loading, to restore chewing function.The prosthetic restorations used are single crowns, bridges andpartial or full dentures, which are connected to the implants bythe corresponding elements (abutments). | |
| Materials: | Versions of the subject devices will be produced from atitanium-13zirconium alloy, trade named Roxolid®, aspreviously reviewed and cleared to market per premarketnotification submission K140878.The transfer piece is produced from titanium-6aluminum-7niobium alloy (TAN). This is the same material as for thepredicate transfer pieces cleared to market per premarketnotification submission K140878. | |
| TechnologicalCharacteristics: | The subject devices are identical in every respect to theidentified Bone Level Tapered predicate devices with theexception of overall length; the subject device is 18 mm inlength where the longest previously cleared Bone LevelTapered devices previously cleared to market per K140878 andK150938 is 16 mm in length.The 18 mm length subject devices have the same length as theNeodent CM Drive device cleared to market per K150182,however the Neodent CM Drive devices have a minimumdiameter of Ø3.5 mm where the subject device has a minimumdiameter of Ø3.3 mm. |
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| Feature | Primary Predicate DeviceBone Level Tapered Implants(K140878) | Subject DevicesBone Level Tapered Implants |
|---|---|---|
| Indications For Use | Straumann® dental implants are indicatedfor oral endosteal implantation in theupper and lower jaw and for thefunctional and esthetic oral rehabilitationof edentulous and partially dentatepatients. Straumann dental implants canalso be used for immediate or earlyimplantation following extraction or lossof natural teeth. Implants can be placedwith immediate function on single-toothand/or multiple tooth applications whengood primary stability is achieved andwith appropriate occlusal loading, torestore chewing function. The prostheticrestorations used are single crowns,bridges and partial or full dentures, whichare connected to the implants by thecorresponding elements (abutments). | Straumann® Bone Level Tapered Implantsare indicated for oral endostealimplantation in the upper and lower jawand for the functional and esthetic oralrehabilitation of edentulous and partiallydentate patients. Straumann Bone LevelTapered Implants can also be used forimmediate or early implantationfollowing extraction or loss of naturalteeth. Implants can be placed withimmediate function on single-tooth and/ormultiple tooth applications when goodprimary stability is achieved and withappropriate occlusal loading, to restorechewing function. The prostheticrestorations used are single crowns,bridges and partial or full dentures, whichare connected to the implants by thecorresponding elements (abutments). |
| Implant-to-AbutmentConnection | Narrow CrossFit® (NC)Regular CrossFit® (RC) | Narrow CrossFit® (NC)Regular CrossFit® (RC) |
| Implant Diameter | Ø3.3mm, Ø4.1mm, Ø4.8mm | Ø3.3mm, Ø4.1mm, Ø4.8mm |
| Implant Length | 8, 10, 12, 14, 16 mm | 18 mm |
| Coronal Thread Form | Constant major and minor threaddiameters (i.e., parallel wall)0.8mm thread pitch | Constant major and minor threaddiameters (i.e., parallel wall)0.8mm thread pitch |
| Material | Titanium Grade 4Titanium zirconium alloy Ti-13Zr | Titanium zirconium alloy Ti-13Zr |
| Surface Finish | SLASLActive | SLASLActive |
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| Performance Data: | Per Guidance for Industry and FDA Staff - Class II SpecialControls Guidance Document: Root-form Endosseous DentalImplants and Endosseous Dental Abutments dated May 12,2004, the substantial equivalence of the subject device(s) aresatisfactorily addressed via bench studies. The followingstudies are incorporated into this submission by reference to thesubmission for the primary predicate (K140878):Dynamic fatigue test data consistent with FDA guidanceand ISO 14801Biological compatibility per the ISO 10993 series standardsSterilization validation per the ISO 11137 series standardsShelf life (stability) per ASTM F1980 |
|---|---|
| In order to confirm that the reduced minimum implant diameterbetween the subject device (Ø3.3 mm) and the Neodent CMDrive reference device (Ø3.5 mm) does not result in a newfailure mode, the following additional bench study wasperformed on all three diameters of the subject device:Peak insertion torque was measured while driving theimplants to a clinically appropriate position relative to thesurface of simulated bone material (polyurethane foam)having densities of between 10 and 40 pounds per cubicfoot that had been prepared per the instructions for use. | |
| Conclusions: | Based upon our assessment of the design and applicableperformance data, the subject devices have been determined tobe 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.