(136 days)
None
No
The summary describes a mechanical dental abutment and its performance in bench testing, with no mention of AI or ML technology.
No.
The device modifies the shape of screw-retained abutments for dental implants. Its purpose is to restore chewing function by providing support for crowns, bridges, and bars, which is a structural and functional restoration, not a therapeutic treatment.
No
The device is an abutment for dental implants, described as providing support for prosthetic reconstructions and restoring chewing function. Its purpose is mechanical and restorative, not diagnostic.
No
The device description clearly states it is a physical abutment, a hardware component used in dental implants.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing support for prosthetic reconstructions (crowns, bridges, bars) on dental implants to restore chewing function. This is a mechanical and structural function within the body.
- Device Description: The description details a modification to a dental abutment, focusing on its mechanical performance (dynamic fatigue).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as a component of a dental restoration.
N/A
Intended Use / Indications for Use
The Straumann® screw-retained abutments are indicated to be placed implants 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 subject device is a modification of the NC Straight Ø4.6 mm GH 1.0 mm Screw Retained Abutment originally cleared to market per K133421. Dimensional changes have resulted in improved dynamic fatigue performance such that this device can now be used in the pre-molar region of the mouth in addition to the incisors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pre-molar region of the mouth, incisors
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to evaluate the fatigue load limits of the proposed Straumann® Screw-Retained Abutment. Dynamic fatigue tests were conducted in accordance with the FDA guidance document dated May 12, 2004: “Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseious Dental Implants and Endosseous Dental Abutments“ and ISO 14801.
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.
None
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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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" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
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: K150814
Trade/Device Name: Straumann Screw-Retained Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 6, 2015 Received: July 8, 2015
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.
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 | 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) K150814
Device Name Straumann Screw Retained Abutments
Indications for Use (Describe)
The Straumann® screw-retained abutments are indicated to be placed implants 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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510(k) Summary
K150814
| Submitter: | Straumann USA, LLC
(on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Christopher Klaczyk
Director of Regulatory and Clinical Affairs
christopher.klaczyk@straumann.com
978.747.2575 |
| Preparation Date: | August 5, 2015 |
| Product Code: | NHA (21 CFR §872.3630) |
| Device Class: | II (21 CFR §872.3630) |
| Classification Panel: | Dental |
| Classification Name: | Endosseous dental implant abutment (21 CFR §872.3630) |
| Proprietary Name: | Straumann® Screw-Retained Abutment |
| Primary Predicate: | (K133421) Straumann® Magellan™ Screw Retained Abutment System |
| Reference Devices: | None |
| Device Description: | The subject device is a modification of the NC Straight Ø4.6 mm GH
1.0 mm Screw Retained Abutment originally cleared to market per
K133421. Dimensional changes have resulted in improved dynamic
fatigue performance such that this device can now be used in the pre-
molar region of the mouth in addition to the incisors. |
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| Indications For Use: | The Straumann® Screw-Retained Abutments are indicated to be placed into Straumann dental implants 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. |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Straumann® Screw-Retained Abutments are intended to be placed into Straumann® dental implants to provide support for prosthetic reconstructions such as crowns and bridges. |
| Technological Characteristics: | See table below. |
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| Feature | Subject Device Straumann®
Screw-Retained Abutment | Primary Predicate Device
Straumann® Magellan™ Screw-
Retained Abutments
(K133421) | Equivalence Discussion |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use | Straumann® Screw-Retained
Abutments are indicated to be
placed into dental implants to
provide support for prosthetic
reconstructions such as crown,
bridges and bars. The final
processed devices have the
purpose of restoring chewing
function. Straumann® screw-
retained abutments are
indicated for screw-retained
restorations. | Straumann® Magellan™ Screw-
Retained Abutments are indicated
to be placed into dental implants to
provide support for prosthetic
reconstructions such as crown,
bridges and bars. The final
processed devices have the
purpose of restoring chewing
function. Magellan™
abutments are indicated for
screw-retained restorations. | Equivalent
Magellan project name is not
being used as a trade name. |
| Abutment Material | Titanium Alloy (Ti-6Al-7Nb) | Titanium Alloy (Ti-6Al-7Nb) | Identical |
| Abutment Platform
Diameter | Ø 4.6 mm | Ø 4.6 mm | Identical |
| Abutment Platform
Thickness | 0.55 mm | 0.20 mm | Equivalent
The platform thickness does not
affect the implant or the prosthetic
interfaces of the abutment;
affecting only the emergence
profile between the implant and
the abutment platform. |
| Gingival Height | 1 mm | 1 mm | Identical |
| Abutment Apical
Geometry | Engaging Bone Level NC | Engaging Bone Level NC | Identical |
| Feature | Subject Device Straumann®
Screw-Retained Abutment | Primary Predicate Device
Straumann® Magellan™ Screw-
Retained Abutments
(K133421) | Equivalence Discussion |
| Abutment Coronal
Geometry | Straight, 22° Conic taper, 1.9 mm
tall, with milled flats; supports
engaging and non-engaging
prostheses | Straight, 22° Conic taper, 1.9 mm
tall, with milled flats; supports
engaging and non-engaging
prostheses | Identical |
| Packaging | PETG thermoformed tray with
Tyvek 1073B lid | PETG thermoformed tray with
Tyvek 1073B lid | Identical |
| Sterilization | Device provided non-sterile.
Instructions provided for terminal
sterilization by the clinician via
steam at 134℃ for 5 minutes. | Device provided non-sterile.
Instructions provided for terminal
sterilization by the clinician via
steam at 134℃ for 5 minutes. | Identical |
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| Substantial
Equivalence
Discussion: | The Indications For Use of the subject and predicate devices are the
same. The overall abutment material, height, diameter, implant-to-
abutment interface, coronal geometry, packaging and sterilization
method are unchanged.
The only difference between the subject Straumann® NC Straight Ø4.6
mm GH 1.0 mm Screw-Retained Abutment and the predicate
Straumann® NC Straight Ø4.6 mm GH 1.0 mm Screw-Retained
Abutment cleared to market per K133421 is the angle of the transition
between the apical implant-to-abutment interface and the coronal
restoration platform resulting from a change in the thickness of the
restoration platform. This change in the external geometry has resulted
in greater wall thickness in the flexure zone of the abutment which has
resulted in improved dynamic fatigue performance. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Testing: | Bench testing was performed to evaluate the fatigue load limits of the
proposed Straumann® Screw-Retained Abutment. Dynamic fatigue
tests were conducted in accordance with the FDA guidance document
dated May 12, 2004: “Guidance for Industry and FDA Staff – Class II
Special Controls Guidance Document: Root-form Endosseious Dental
Implants and Endosseous Dental Abutments“ and ISO 14801. |
| Conclusion: | 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. |