(91 days)
Not Found
No
The document describes a dental abutment, a mechanical component, and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are bench studies focused on mechanical properties.
No
The device restores chewing function, which is a physiological function rather than directly treating or preventing a disease or condition. While it supports prosthetic reconstructions, its primary purpose isn't therapeutic in the medical sense.
No
The device is an abutment for dental implants, used to support prosthetic reconstructions. Its purpose is to restore chewing function, not to diagnose medical conditions.
No
The device description clearly states it is a line extension of "Screw Retained Abutments" and describes physical components like "one-piece straight and angled (17° and 30°) abutments, having a gingival height of 5.5 mm." This indicates a physical medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "provide support for prosthetic reconstructions such as crowns, bridges and bars" and "restoring chewing function." This describes a device used in vivo (within the body) for a structural and functional purpose.
- Device Description: The description details a physical implant component (abutment) that is placed into a dental implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used to analyze samples like blood, urine, or tissue to detect diseases, conditions, or infections. This device is a physical component used in dental restoration.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The proposed Bone Level Screw Retained Abutments are a line extension of the Screw Retained Abutments previously cleared to market per K133421 and K141871. The proposed Screw Retained Abutment devices include one-piece straight and angled (17° and 30°) abutments, having a gingival height of 5.5 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
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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 Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Christopher Klaczyk
Director 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 System
Primary Predicate
• K141871, NC Angled Screw Retained Abutments
Reference Predicate |
| Device Description: | The proposed Bone Level Screw Retained Abutments are a line
extension of the Screw Retained Abutments previously cleared
to market per K133421 and K141871. The proposed Screw
Retained Abutment devices include one-piece straight and
angled (17° and 30°) abutments, having a gingival height of 5.5
mm. |
| Indications For Use: | 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. |
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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 Devices
NC & RC Screw Retained
Abutments | Predicate Devices
Screw Retained Abutments
(K133421, K141871) |
|-----------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Implant-to-Abutment
Connection | Narrow Cross Fit (NC)
Regular Cross Fit (RC) | Narrow Cross Fit (NC)
Regular Cross Fit (RC) |
| Platform Diameter(s) | NC: Ø4.6 mm
RC: Ø4.6 mm | NC: Ø3.5 mm, Ø4.6 mm
RC: 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 mm
RC: 5.5 mm | NC: 1.0, 2.5 and 4.0 mm
RC: 1.0, 2.5 and 4.0 mm |
| Orientation of Angulation
to 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 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) |
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.