(91 days)
The Straumann® Screw Retained Abutments are indicated to be placed into the NC and RC Bone Level 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.
Here's an analysis of the provided text regarding acceptance criteria and studies, with the understanding that this document is a 510(k) summary for a medical device and not a report for an AI/ML device. Therefore, many of the requested fields related to AI/ML studies will not be applicable.
The document discusses the Straumann® Screw Retained Abutments, which are dental implant components.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for performance. Instead, it demonstrates substantial equivalence to predicate devices through material and technological characteristics, and performance data from bench studies.
| Feature / Criterion | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Material (Composition) | Conformance to ISO 5832-11 (Ti-6Al-7Nb) | Ti-6Al-7Nb titanium alloy conforming to ISO 5832-11 |
| Manufacturing Process | Precision machining from solid material (one-piece construction) | Precision machining from solid material (one-piece construction) |
| Mechanical Strength/Durability (Fatigue) | Consistent with FDA guidance and ISO 14801 | Dynamic fatigue test data consistent with FDA guidance and ISO 14801 was referenced. (Specific numerical results not provided in this summary) |
| Implant-to-Abutment Connection | Identical to predicate devices (NC, RC Cross Fit) | NC & RC Cross Fit |
| Platform Diameter(s) | Equivalent/Comparable to predicate devices | NC: Ø4.6 mm, RC: Ø4.6 mm (Note: Predicate had NC: Ø3.5 mm, Ø4.6 mm, RC: Ø4.6 mm) |
| Abutment Angulation(s) | Equivalent/Comparable to predicate devices | NC: 17°, 30°, RC: 17°, 30° (Note: Predicate had 0°, 17°, 30°) |
| Gingival Height(s) | Equivalent/Comparable to predicate devices | NC: 5.5 mm, RC: 5.5 mm (Note: Predicate had 1.0, 2.5 and 4.0 mm) |
| Orientation of Angulation to Engagement Features | Identical to predicate devices (Type A (45°), Type B (0°)) | NC: Type A (45°), Type B (0°), RC: Type A (45°), Type B (0°) |
| Primary Package | Medical grade polyethylene blister with a sealing lid | Medical grade polyethylene blister with a sealing lid |
| Sterilization | Non-sterile; intended for terminal sterilization via moist heat (autoclave) | Non-sterile; intended for terminal sterilization via moist heat (autoclave) |
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 refers to "bench studies" and "dynamic fatigue test data" but does not explicitly state the sample size (number of abutments tested) for these tests. There's no information about the country of origin of the data or whether it was retrospective or prospective, as these are typically not relevant for benchtop mechanical testing of physical devices.
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 not applicable as the device is a physical dental implant abutment, not an AI/ML imaging analysis tool. "Ground truth" in this context would come from engineering specifications, material standards, and physical measurements/tests, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical device undergoing bench testing.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for showing substantial equivalence relies on:
- Engineering specifications and material standards: Conformance to ISO standards for material composition (ISO 5832-11) and mechanical testing (ISO 14801).
- Physical measurements: Dimensions (platform diameter, gingival height), angles, and connection types for comparison with predicate devices.
- Bench test results: Data from dynamic fatigue tests to demonstrate mechanical performance under simulated conditions.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 10, 2015
Straumann USA, LLC Christopher Klaczyk Director of Regulatory Affairs and Clinical Research 60 Minuteman Road Andover, Massachusetts 01810
Re: K151247
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 10, 2015 Received: July 13, 2015
Dear Mr. Christopher 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,
Erin I. Keith -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
Enclosure
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Indications for Use
510(k) Number (if known) K151247
Device Name
Straumann® Screw Retained Abutments
Indications for Use (Describe)
The Straumann® Screw Retained Abutments are indicated to be placed into the NC and RC Bone Level 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.
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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K151247
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: | August 9, 2015 |
| Product Code(s): | NHA (21 CFR 872.3630) |
| Device Class: | II (21 CFR 872.3630) |
| Classification Panel: | Dental |
| Classification Name: | Endosseous dental abutment (21 CFR 872.3630) |
| Proprietary Name: | Straumann® Screw Retained Abutments |
| Predicate Device(s): | • K133421, Straumann® Magellan Abutment SystemPrimary Predicate• K141871, NC Angled Screw Retained AbutmentsReference Predicate |
| Device Description: | The proposed Bone Level Screw Retained Abutments are a lineextension of the Screw Retained Abutments previously clearedto market per K133421 and K141871. The proposed ScrewRetained Abutment devices include one-piece straight andangled (17° and 30°) abutments, having a gingival height of 5.5mm. |
| Indications For Use: | The Straumann® Screw Retained Abutments are indicated to beplaced into the NC and RC Bone Level implants of theStraumann® Dental Implant System to provide support forprosthetic reconstructions such as crowns, bridges and bars.The final processed devices have the purpose of restoringchewing function.Straumann® Screw Retained Abutments are indicated forscrew-retained restorations. |
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- Intended Use : Straumann abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Materials : The subject devices are produced from titanium-6aluminum-7niobium alloy (TAN) conforming to ISO 5832-11. This is the same material as for the predicate devices previously cleared to market per premarket notification submissions K133421 and K141871. The proposed Straumann® Screw Retained Abutments are Technological
- manufactured using precision machining systems from solid Characteristics : material (i.e. one-piece construction). All technological characteristics of the subject devices are the same as for predicate devices as shown in the table below.
| Feature | Subject DevicesNC & RC Screw RetainedAbutments | Predicate DevicesScrew Retained Abutments(K133421, K141871) |
|---|---|---|
| Implant-to-AbutmentConnection | Narrow Cross Fit (NC)Regular Cross Fit (RC) | Narrow Cross Fit (NC)Regular Cross Fit (RC) |
| Platform Diameter(s) | NC: Ø4.6 mmRC: Ø4.6 mm | NC: Ø3.5 mm, Ø4.6 mmRC: Ø4.6 mm |
| Abutment Angulation(s) | NC: 17°, 30°RC: 17°, 30° | NC: 0°, 17°, 30°RC: 0°, 17°, 30° |
| Gingival Height(s) | NC: 5.5 mmRC: 5.5 mm | NC: 1.0, 2.5 and 4.0 mmRC: 1.0, 2.5 and 4.0 mm |
| Orientation of Angulationto Engagement Features | NC: Type A (45°), Type B (0°)RC: Type A (45°), Type B (0°) | NC: Type A (45°), Type B (0°)RC: Type A (45°), Type B (0°) |
| Material | Ti-6Al-7Nb titaniumalloy | Ti-6Al-7Nb titaniumalloy |
| 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) |
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.
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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.)