(27 days)
The Straumann® Screw Retained Abutments are indicated to be placed into the implants of the Straumann® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars.
The final processed devices have the purpose of restoring chewing function.
Straumann® Screw Retained Abutments are indicated for screw-retained restorations.
The proposed Straumann® NC Angled Screw Retained Abutments are a line extension of the NC Straight and RC Straight and Angled Screw Retained Abutments cleared to market per premarket notification submission K133421.
The Straumann® NC Angled Screw Retained Abutments include 17° and 30° abutments. This is consistent with the RC Angled Screw Retained Abutments cleared to market per premarket notification submission K133421.
This document is a 510(k) premarket notification for the Straumann® Screw Retained Abutments, a dental device. It focuses on demonstrating the substantial equivalence of the new device to existing predicate devices.
Here's a breakdown of the requested information based on the provided text:
1-7. Acceptance Criteria and Study Details
The document refers to bench studies and dynamic fatigue test data consistent with FDA guidance and ISO 14801 as the means to establish substantial equivalence. For medical devices like dental abutments, acceptance criteria often relate to mechanical properties, material compatibility, and structural integrity under simulated physiological conditions.
However, the specific numerical acceptance criteria (e.g., minimum fatigue life, maximum deformation) and the reported device performance against these criteria are not explicitly tabulated or detailed in the provided text. The document states: "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." This implies the performance met unstated acceptance criteria.
Let's address the specific points you requested based on the available information:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the provided text. They would likely be defined by ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants) and FDA guidance for endosseous dental implants and abutments. These typically involve demonstrating a certain number of load cycles at specific force levels without fracture or permanent deformation exceeding a threshold.
- Reported Device Performance: Not explicitly detailed with specific numerical results in the provided text. The document only concludes that the performance data "satisfactorily addressed" substantial equivalence.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided text. For mechanical bench testing, sample sizes are typically smaller than clinical trials, often statistical minimums (e.g., 5-10 samples per test group) to ensure statistical significance.
- Data Provenance: The studies were bench studies, presumably conducted by or for Straumann USA, LLC (or Institut Straumann AG). The country of origin of the data is not specified but would likely be where the manufacturing and testing facilities are located for Straumann (e.g., USA, Switzerland). The studies are by nature prospective as they are conducted specifically to demonstrate performance for regulatory submission.
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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 question is largely not applicable in the context of this specific device and the provided document. The "ground truth" for mechanical testing is derived from objective physical measurements and engineering specifications, not expert consensus in the way a diagnostic imaging device would require. The experts involved would be engineers and material scientists conducting the tests and analyzing the data, but their "number" and "qualifications" for establishing ground truth are not relevant in the same manner as for clinical interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None (in the typical clinical sense): Adjudication methods like 2+1 or 3+1 are used for clinical studies where human interpretation of data (e.g., imaging scans) requires consensus among multiple experts. For bench testing of mechanical properties, "adjudication" is not performed in this manner. Results are usually objective measurements that are verified against established test protocols and specifications.
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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:
- No: An MRMC comparative effectiveness study is not applicable. This device is a physical dental abutment, not an AI or diagnostic imaging device that requires human readers for interpretation. Therefore, there's no "AI assistance" or "human readers" in this context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No: This question is not applicable. The device is a physical dental abutment, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context refers to engineering specifications, material science standards (e.g., ISO 5832-11 for the alloy, ISO 14801 for fatigue testing), and mechanical performance metrics. The objective measurements from the bench studies (e.g., number of cycles to failure, measured deformation) are compared directly against these predefined engineering standards and specifications.
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The sample size for the training set:
- Not applicable: This device is not an AI algorithm, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable: As there is no training set, this question is not relevant.
In summary, for K141871 (Straumann® Screw Retained Abutments):
The acceptance criteria and device performance are established through adherence to recognized international standards (like ISO 14801) for mechanical fatigue testing, and material specifications (like ISO 5832-11 for titanium alloy). The document states that bench studies and dynamic fatigue test data were provided and deemed satisfactory to demonstrate substantial equivalence to predicate devices, but it does not provide the specific numerical results or detailed acceptance criteria. The context is mechanical engineering validation, not clinical diagnostic performance or AI evaluation.
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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 features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2014
Straumann USA, Limited Liability Company Mr. Christopher Klaczyk Director of Regulatory Affairs & Clinical Research 60 Minuteman Road Andover, MA 01810
Re: K141871
Trade/Device Name: Straumann® Screw Retained Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 9, 2014 Received: July 11, 2014
Dear Mr. Klaczyk:
This letter corrects our substantially equivalent letter of August 7, 2014.
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 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" (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 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 vours.
Mary S. Runner -S
Erin I. Keith 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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4. Indications For Use
510(k) Number (if known): K141871
Straumann® Screw Retained Abutments Device Name:
Indications for Use:
The Straumann® Screw Retained Abutments are indicated to be placed into the implants of the Straumann® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars.
The final processed devices have the purpose of restoring chewing function.
Straumann® Screw Retained Abutments are indicated for screw-retained restorations.
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)
Sheena A. Green-S 2014.08.07 13:44:29-04'00'
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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 ResearchTel.: (978) 747-2575 | |
| Date Prepared: | July 9, 2014 | |
| Product Code(s): | NHA (21 CFR 872.3630) | |
| Device Class: | (21 CFR 872.3630)II | |
| Classification Panel: | Dental | |
| Classification Name: | Endosseous dental implant abutments (21 CFR 872.3630) | |
| Proprietary Name: | Straumann® Screw Retained Abutments | |
| Predicate Device(s): | Straumann® Magellan Abutment System (K133421)● | |
| Device Description: | The proposed Straumann® NC Angled Screw RetainedAbutments are a line extension of the NC Straight and RCStraight and Angled Screw Retained Abutments cleared tomarket per premarket notification submission K133421. | |
| The Straumann® NC Angled Screw Retained Abutmentsinclude 17° and 30° abutments. This is consistent with the RCAngled Screw Retained Abutments cleared to market perpremarket notification submission K133421. | ||
| Intended Use: | The Straumann® Screw Retained Abutments are indicated to beplaced into the implants of the Straumann® Dental ImplantSystem to provide support for prosthetic reconstructions such ascrowns, bridges and bars. | |
| The final processed devices have the purpose of restoringchewing function. | ||
| Straumann® Screw Retained Abutments are indicated forscrew-retained restorations. | ||
| Materials: | The subject devices are produced from titanium-6aluminum-7niobium alloy (TAN) conforming to ISO 5832-11. This is thesame material as for the predicate abutments cleared to marketper premarket notification submission K133421. | |
| TechnologicalCharacteristics: | The proposed Straumann® NC Angled Screw RetainedAbutments are manufactured using precision machiningsystems from solid material (i.e. one-piece construction). Alltechnological characteristics of the subject devices are the sameas for devices as shown in the table below. |
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| Feature | Subject DevicesNC Angled Screw RetainedAbutments | Predicate DevicesMagellan Abutment SystemK133421 |
|---|---|---|
| Implant-to-AbutmentConnection | Narrow CrossFit (NC) | Narrow CrossFit (NC)Regular CrossFit (RC) |
| Interface Type | Engaging | Engaging |
| Platform Diameter(s) | NC: Ø4.6 mm | NC: Ø3.5 mm, Ø4.6 mmRC: Ø4.6 mm |
| Abutment Angulation(s) | NC: 17°, 30° | NC: 0°RC: 0°, 17°, 30° |
| Gingival Height(s) | NC Angled: 2.5 mm, 4.0 mm | NC Straight: 1.0, 2.5 and 4.0 mmRC Straight: 1.0, 2.5 and 4.0 mmRC Angled: 2.5 and 4.0 mm |
| Orientation of Angulationto Engagement Features | NC: Type A (45°), Type B (0°) | NC: N/ARC: Type A (45°), Type B (0°) |
| Material | Ti-6Al-7Nb titanium alloy | Ti-6Al-7Nb titanium alloy |
| Primary Package | Medical grade polyethylene blisterwith a sealing lid | Medical grade polyethylene blisterwith a sealing lid |
| Sterilization | Non-sterile; intended for terminalsterilization via moist heat(autoclave) | Non-sterile; intended for terminalsterilization via moist heat(autoclave) |
Per Guidance for Industry and FDA Staff - Class II Special Performance Data: 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.
- Based upon our assessment of the design and applicable Conclusions: 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.)