(135 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). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
The subject devices represent a line extension of the previously cleared Bone Level implants of the Straumann Dental Implant System (K062129, K083550 and K121131). 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 lengths (8 to 14 mm), the same materials (CP Ti and Ti-13Zr) and the same surface finishes (SLA, SLActive) as the identified predicate devices. The subject devices differ in that the apical aspect of the implants incorporate a tapering thread form, the apical aspect of the implants incorporate three cutting flutes, an additional length of 16mm and the transfer piece is of a new design.
The provided text is a 510(k) premarket notification for a medical device, specifically dental implants. It focuses on demonstrating substantial equivalence to existing predicate devices rather than providing acceptance criteria and performance data in the traditional sense of a study proving performance against defined metrics.
Therefore, much of the requested information cannot be extracted directly from this document because it describes a different type of regulatory submission. This document aims to establish that the new device is as safe and effective as a legally marketed predicate device, not necessarily to meet specific, quantifiable performance targets with a detailed clinical study.
However, I can extract information related to the device characteristics and the type of evidence provided for substantial equivalence.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be fully provided as requested. The document doesn't define explicit "acceptance criteria" against which the device performance is measured in a quantitative manner, like sensitivity, specificity, accuracy, or a specific failure rate.
- Instead, for dental implants, "performance" is demonstrated through technological characteristics and non-clinical bench studies (specifically dynamic fatigue testing) to show "substantial equivalence" to predicate devices.
- The comparison table provided (Page 6) shows technological characteristics of the subject device (Straumann® Bone Level Tapered Implants) versus predicate devices. This implicitly suggests that being similar or equivalent in these characteristics is the "acceptance criteria" for substantial equivalence.
| Feature | Acceptance Criteria (Predicate Characteristics) | Reported Device Performance (Subject Device Characteristics) |
|---|---|---|
| Implant-to-Abutment Connection | 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, 14mm | 8, 10, 12, 14, 16mm (Note: new 16mm length added) |
| Coronal Thread Form | Constant major and minor thread diameters (parallel wall), 0.8mm thread pitch | Constant major and minor thread diameters (parallel wall), 0.8mm thread pitch |
| Apical Thread Form | Constant major and minor thread diameters (parallel wall), 0.8mm thread pitch | Angled major and minor thread diameters (tapered wall), with differing major/minor diameters such that depth increases toward apical end, with cutting flutes. 0.8mm thread pitch. (Note: This is a design difference from the predicate, justified by equivalence to Nobel predicates with tapered forms and cutting flutes.) |
| Surface Finish | SLA, SLActive | SLA, SLActive |
| Transfer Piece | Thread mount transfer piece | Snap fit mount Loxim™ transfer piece (Note: new design, but serves same intended function) |
| Material | Commercially pure grade 4 titanium & Titanium-13Zirconium alloy (Roxolid®) | Commercially pure grade 4 titanium & Titanium-13Zirconium alloy (Roxolid®) |
| Primary Package SLActive | Vial of styrene-butadiene block copolymer (Styrolux), vial cap of LDPE, implant holder of Grilamid TR70 polyamide, filled with aqueous NaCl solution. | Vial of styrene-butadiene block copolymer (Styrolux), vial cap of LDPE, implant holder of Grilamid TR70 polyamide, filled with aqueous NaCl solution. |
| Sterilization | Gamma Irradiation, 25 kGy minimum, Validated per ISO 11137-1 and ISO 11137-2 to an SAL of 1 x 10^-6 | Gamma Irradiation, 25 kGy minimum, Validated per ISO 11137-1 and ISO 11137-2 to an SAL of 1 x 10^-6 |
| Dynamic Fatigue Performance | Consistent with FDA guidance and ISO 14801 (implied successful performance by predicates) | Data shows that the subject devices provide performance that is substantially equivalent to the identified predicate devices (demonstrated through bench studies per ISO 14801 and FDA guidance). This is the key "performance" reported to meet substantial equivalence. The specific numerical acceptance criteria for fatigue are not detailed here, only that the subject device meets the criteria that the predicates met. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document refers to "bench studies" for dynamic fatigue testing (Page 7). This typically involves mechanical testing rigs, not human or animal subjects, so terms like "test set," "data provenance," "retrospective/prospective" in a clinical sense are not applicable. The sample size for materials testing would be part of the ISO 14801 standard and the specific test protocols, which are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This information is relevant for studies involving human interpretation or pathology, which is not the case for this technical submission based on bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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 device is a dental implant (a physical medical device), not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. See point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the bench testing (dynamic fatigue), the "ground truth" or standard for acceptable performance would be defined by ISO 14801 standards and FDA guidance for dental implants. Success is failure to fracture or deform beyond acceptable limits under specified loading conditions.
- For the overall substantial equivalence determination, the "ground truth" is typically the performance of the legally marketed predicate devices. The new device aims to be as safe and effective as these established devices.
8. The sample size for the training set
- Not applicable. This device is hardware, not an AI algorithm requiring a training set in the computational sense.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design. The profiles are facing to the right and are stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 20, 2014
Straumann USA, LLC Mr. Christopher Klaczyk Director of Regulatory Affairs and Clinical Research 60 Minuteman Road Andover, MA 01810
Re: K140878
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: July 22, 2014 Received: July 23, 2014
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.
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Page 2 - Mr. Klaczyk
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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Mary S. Runner -S
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
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4. Indications For Use
510(k) Number (if known): K140878
Straumann® Bone Level Tapered Implant Device Name: Roxolid SLActive
Indications for Use:
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).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
{3}------------------------------------------------
510(k) Number (if known): K140878 Straumann® Bone Level Tapered Implant Device Name: Titanium SLA
Indications for Use:
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). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
{4}------------------------------------------------
5. 510(k) Summary
| 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 Affairs and Clinical Research |
| Date Prepared: | April 22, 2014 |
| 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 Implants |
| Predicate Device(s): | ● Straumann P.004 Implants – Ti Bone Level implants (K062129)● Straumann Dental Implant System – 3.3mm NC TiZr Bone Level implants (K083550)● Straumann Dental Implant System – 4.1& 4.8mm TiZr Bone Level implants (K121131)● Straumann Dental Implant System (K123784)● Straumann Dental Implant System (K130222)● Straumann Tissue Level Titanium Implants (K983742)● Straumann NC Anatomic Abutment (K071357)● Straumann NC Cares Abutments (K081005)● Nobel Biocare, NobelSpeedy (K050406)● Nobel Biocare, NobelActive (K071370) |
| Device Description: | The subject devices represent a line extension of the previouslycleared Bone Level implants of the Straumann Dental ImplantSystem (K062129, K083550 and K121131). The subjectdevices have the same diameters (3.3, 4.1 and 4.8 mm), thesame implant-to-abutment interfaces (NC, RC) the same lengths(8 to 14 mm), the same materials (CP Ti and Ti-13Zr) and thesame surface finishes (SLA, SLActive) as the identifiedpredicate devices. The subject devices differ in that the apicalaspect of the implants incorporate a tapering thread form, the |
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apical aspect of the implants incorporate three cutting flutes, an additional length of 16mm and the transfer piece is of a new design.
| Intended Use:Roxolid SLActive | Straumann® dental implants are indicated for oral endostealimplantation in the upper and lower jaw and for the functionaland esthetic oral rehabilitation of edentulous and partiallydentate patients. Straumann dental implants can also be usedfor immediate or early implantation following extraction or lossof natural teeth. Implants can be placed with immediatefunction on single-tooth and/or multiple tooth applicationswhen good primary stability is achieved and with appropriateocclusal loading, to restore chewing function. The prostheticrestorations used are single crowns, bridges and partial or fulldentures, which are connected to the implants by thecorresponding elements (abutments). |
|---|---|
| Intended Use:Titanium SLA | Straumann® dental implants are indicated for oral endostealimplantation in the upper and lower jaw and for the functionaland esthetic oral rehabilitation of edentulous and partiallydentate patients. Straumann dental implants can also be usedfor immediate or early implantation following extraction or lossof natural teeth. Implants can be placed with immediatefunction on single-tooth and/or multiple tooth applicationswhen good primary stability is achieved and with appropriateocclusal loading, to restore chewing function. The prostheticrestorations used are single crowns, bridges and partial or fulldentures, which are connected to the implants by thecorresponding elements (abutments). In cases of fullyedentulous patients, 4 or more implants must be used inimmediately loaded cases. |
| Materials: | Versions of the subject devices will be produced from eithergrade 4 commercially pure titanium conforming with ISO 5832-2 or a titanium-13zirconium alloy, trade named Roxolid®, aspreviously reviewed and cleared to market per premarketnotification submissions K083550 and K121131 for thepredicate devices, as well as K081419, K111357 and K122855. |
| The transfer piece is produced from titanium-6aluminum-7niobium alloy (TAN) conforming with ISO 5832-11. This isthe same material as for the predicate transfer pieces cleared tomarket per premarket notification submissions K062129,K083550 and K121131. |
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| Technological | The subject devices have the same Indications For Use, |
|---|---|
| Characteristics: | diameters (3.3, 4.1 and 4.8 mm), lengths (8 to 14 mm), implant- |
| to-abutment connections (NC, RC), materials (CP Ti and Ti- | |
| 13Zr), surface finishes (SLA, SLActive), coronal thread form, | |
| packaging, sterilization process and dynamic fatigue | |
| performance as the identified Bone Level predicate devices (see | |
| comparison below). |
The subject devices have an equivalent apical tapered thread form with cutting flutes as the identified Nobel predicates.
| Feature | Predicate DevicesBone Level Implants(K062129, K083550, K121131) | Subject DevicesBone Level Tapered Implants |
|---|---|---|
| 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, 14mm | 8, 10, 12, 14, 16mm |
| Coronal Thread Form | Constant major and minor thread diameters(i.e., parallel wall)0.8mm thread pitch | Constant major and minor thread diameters(i.e., parallel wall)0.8mm thread pitch |
| Apical Thread Form | Constant major and minor thread diameters(i.e., parallel wall)0.8mm thread pitch | Angled major and minor thread diameters(i.e., tapered wall), with the major andminor diameters have differing angles suchthat the depth increases toward the apicalend of the implant and the addition ofcutting flutes.0.8mm thread pitch |
| Surface Finish | SLA, SLActive | SLA, SLActive |
| Transfer Piece | Thread mount transfer pieceIntended to support the implant while in theprimary package, to aid in the removal ofthe implant from the primary package, andto aid in placement of the implant into theosteotomy site. | Snap fit mount Loxim™ transfer pieceIntended to support the implant while in theprimary package, to aid in the removal ofthe implant from the primary package, andto aid in placement of the implant into theosteotomy site. |
| Material | Commercially pure grade 4 titanium &Titaniun-13Zirconium alloy (Roxolid®) | Commercially pure grade 4 titanium &Titaniun-13Zirconium alloy (Roxolid®) |
| Primary PackageSLActive | Vial of styrene-butadiene block copolymer(Styrolux), vial cap of LDPE and animplant holder of Grilamid TR70polyamide.As delivered, the package is filled withaqueous NaCl solution. | Vial of styrene-butadiene block copolymer(Styrolux), vial cap of LDPE and animplant holder of Grilamid TR70polyamide.As delivered, the package is filled withaqueous NaCl solution. |
| Sterilization | Gamma Irradiation, 25 kGy minimumValidated per ISO 11137-1 and ISO 11137-2 to an SAL of 1 x 10-6 | Gamma Irradiation, 25 kGy minimumValidated per ISO 11137-1 and ISO 11137-2 to an SAL of 1 x 10-6 |
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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. Dynamic fatigue testdata consistent with FDA guidance and ISO 14801 have beenreferenced in support of this submission. This data shows thatthe subjects devices provide performance that is substantiallyequivalent to the identified predicate devices. |
|---|---|
| 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.
- Straumann USA, LLC
§ 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.