(51 days)
Not Found
No
The summary describes a physical dental abutment and its mechanical testing, with no mention of software, algorithms, or AI/ML terms.
No
The device, a dental abutment, is intended to support prosthetic reconstructions, not to treat or cure a disease or condition, which is the primary function of a therapeutic device.
No
The device description indicates that the abutments are permanent components placed onto dental implants to support prosthetic reconstructions, rather than for diagnosing any condition.
No
The device description explicitly states the abutments are made of Titanium Grade 4 with a corresponding basal screw made of Titanium Alloy, indicating a physical hardware device.
No, 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 Function: The provided description clearly states that the Straumann Narrow Neck CrossFit Cementable Abutments are used in connection with dental implants to support prosthetic reconstructions like crowns and bridges. They are physical components placed within the mouth.
- Lack of Diagnostic Testing: The description does not mention any testing of biological samples or providing diagnostic information. The performance testing described is related to the mechanical integrity and function of the abutment itself.
Therefore, based on the provided information, this device is a dental implant abutment, which is a type of medical device, but not an In Vitro Diagnostic.
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. Straumann Narrow Neck CrossFit (NNC) Cementable Abutments are indicated for cement-retained single tooth and bridge restorations.
Product codes
NHA
Device Description
Straumann Narrow Neck CrossFit (NNC) Cementable Abutments are permanent abutments intended for placement onto the Straumann Narrow Neck CrossFit (NNC) tissue level Implants with the diameter of 3.3mm. The abutments are made of Titanium Grade 4 with a corresponding basal screw made of Titanium Alloy. The abutments are available in straight and 15° angled configurations.
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
Not Found
Summary of Performance Studies
Verification and validation testing were performed to ensure that the Straumann Narrow Neck CrossFit (NNC) Cementable Abutments function as intended and that the modifications do not impact the performance of the device. Testing included: 1. Performance Testing - i. Fatigue Testing in accordance to FDA guidance 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 Sraumann Narrow Neck CrossFit (NNC) Cementable Abutments function as intended and met the pre-determined acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.)
0
Narrow Neck CrossFit (NNC) Cementable Abutments Special 510(k) Section 5: 510(k) Summary
DEC 2 8 2011
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 Fax Number: 978-747-0023 Contact Person: Elaine Alan Senior Regulatory Affairs Specialist
2. Date of Submission: November 4, 2011
3. Name of the Device
| Trade Name: | Straumann Narrow Neck CrossFit (NNC)
Cementable Abutments |
|----------------------|--------------------------------------------------------------|
| Common Name: | NNC Cementable Abutments |
| Classification Name: | Endosseous Dental Implant Abutments |
| Regulation Number: | §872.3630 |
4. Legally Marketed Devices to which Equivalence is Claimed (Predicate Device)
Straumann Narrow Neck Connection (NNC) Gold Abutment for crowns, K111357 Straumann Narrow Connection (NC) Cementable Abutments, K080286 Straumann Narrow Neck (NN) CARES Titanium Abutment, K082545
5. Description of the Device
Straumann Narrow Neck CrossFit (NNC) Cementable Abutments are permanent abutments intended for placement onto the Straumann Narrow Neck CrossFit (NNC) tissue level Implants with the diameter of 3.3mm. The abutments are made of Titanium Grade 4 with a corresponding basal screw made of Titanium Alloy. The abutments are available in straight and 15° angled configurations.
6. Intended Use of the Device
Response Letter: K113283 December 9, 2011 Straumann NNC Cementable Abutments
Straumann, USA Page 7 of 14
1