(164 days)
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No
The document describes a physical dental abutment and its materials, configurations, and testing, with no mention of software, algorithms, or AI/ML capabilities.
No
The device, an abutment for dental implants, is a prosthetic component for restoration, not a device used to treat or cure a disease or medical condition.
No
The device description indicates that abutments are "placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges." This describes a restorative or load-bearing function, not a diagnostic one. There is no mention of the device being used to identify, measure, or monitor a medical condition.
No
The device description explicitly states the abutments are made of Zirconium Dioxide and Titanium Alloy, indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the abutments are physical components placed into dental implants to support prosthetic reconstructions. They are used in the body, not to test samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests, or providing diagnostic information based on laboratory analysis.
The device is a dental implant abutment, which is a type of medical device used in restorative dentistry.
N/A
Intended Use / Indications for Use
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges.
Anatomic IPS e.max Abutments are indicated for screw-retained single-tooth restorations and cement-retained single tooth and bridge restorations.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
Narrow Connection (NC) Straumann Anatomic IPS e.max Abutments are permanent abutments intended for placement onto the Straumann Narrow Connection Bone Level Implants with the diameter of 3.3mm. The abutments are made of Zirconium Dioxide with a corresponding basal screw made of Titanium Alloy. The abutments are available in straight and 15° angled configurations with gingival heights of 2.0mm and 3.5mm, and are available in two colors of white and shaded.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
Verification and validation testing were performed to ensure that the Straumann Narrow Connection (NC) Anatomic IPS e.max Abutments function as intended and that the modifications do not impact the performance of the device. Testing included:
-
- Performance Testing
- i. Fatigue Testing in accordance to FDA quidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."
The results from the testing conducted demonstrated that the Narrow Connection (NC) Straumann Anatomic IPS e.max Abutments function as intended and met the pre-determined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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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AUG 1 2 2011 510(K) Summary
1. Applicant's Name and Address
. "
Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 978-747-0023 Fax Number: Contact Person: Elaine Alan Senior Regulatory Affairs Specialist
2. Date of Submission: February 28, 2011
3. Name of the Device
| Trade Name: | Narrow Connection (NC) Straumann Anatomic
IPS e.max Abutments |
|----------------------|------------------------------------------------------------------|
| Common Name: | NC Anatomic IPS e.max Abutments |
| Classification Name: | Endosseous Dental Implant Abutments |
| Regulation Number: | §872.3630 |
Legally Marketed Device to which Equivalence is Claimed (Predicate 4. Device)
Straumann Modified Dental Abutments, K091701
ર. Description of the Device
Narrow Connection (NC) Straumann Anatomic IPS e.max Abutments are permanent abutments intended for placement onto the Straumann Narrow Connection Bone Level Implants with the diameter of 3.3mm. The abutments are made of Zirconium Dioxide with a corresponding basal screw made of Titanium Alloy. The abutments are available in straight and 15° angled configurations with gingival heights of 2.0mm and 3.5mm, and are available in two colors of white and shaded.
6. Intended Use of the Device
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges.
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Anatomic IPS e.max Abutments are indicated for screw-retained singletooth restorations and cement-retained single tooth and bridge restorations.
7. Technological Characteristics
The proposed device is substantially equivalent to the currently marketed device. They share the same indication for use, material and fundamental operating principles.
8. Performance Testing
Verification and validation testing were performed to ensure that the Straumann Narrow Connection (NC) Anatomic IPS e.max Abutments function as intended and that the modifications do not impact the performance of the device. Testing included:
-
- Performance Testing
- i. Fatigue Testing in accordance to FDA quidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."
9. Conclusion
The results from the testing conducted demonstrated that the Narrow Connection (NC) Straumann Anatomic IPS e.max Abutments function as intended and met the pre-determined acceptance criteria.
The Narrow Connection (NC) Straumann Anatomic IPS e.max Abutments is a validated system. The results of the performance bench testing and risk analysis indicate that the Straumann Narrow Connection (NC) Anatomic IPS e.max Abutments are substantially equivalent to the named predicate device and is safe and effective for its intended use.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human figures, one behind the other, with their arms raised. The figures are black and are arranged in a vertical stack. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Ms. Elaine Alan Senior Regulatory Affairs Specialist Straumann USA 60 Minuteman Road Andover. Massachusetts 01810
AUG 1 2 2011
Rc: K110580
Trade/Device Name: Narrow Connection (NC) Straumann Anatomic IPS e.max Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 22, 2011 Received: June 23, 2011
Dear Ms. Alan:
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 cither 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 – Ms. Alan
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
A. 1
B. W
C. S
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devi Office of Device Evaluation Center of Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K110580
Device Name: Narrow Connection (NC) Straumann Anatomic IPS e.max Abutments
Indications for Use:
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges.
Anatomic IPS e.max Abutments are indicated for screw-retained single-tooth restorations and cement-retained single tooth and bridge restorations.
x AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-the-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of DCRH, Office of Device Evaluation (ODE)
Swart Karr
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control. Dental Devic
510(k) Number: Filos
Straumann, USA Page 17 of 20