(29 days)
Not Found
Not Found
No
The summary describes a physical dental abutment with specific geometric features and does not mention any software, algorithms, or data processing related to AI/ML.
No
The device is described as an abutment for a dental prosthesis, which is a restorative device, not a therapeutic device. It does not actively treat or cure a disease or condition.
No
Explanation: The device is described as an abutment for a dental prosthesis, which is a restorative component, not a tool for diagnosing medical conditions. Its function is to support a cemented prosthesis, not to identify or monitor diseases.
No
The device description clearly indicates it is a physical abutment made of zirconia, which is a 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 tests performed on samples such as blood, urine, or tissue to detect diseases or other conditions. They are used outside of the body.
- Device Description and Intended Use: The Zimmer® Angled Contour Zirconia Abutment is a physical component used in dental prosthetics. It is implanted into the mouth to support a cemented prosthesis. This is a device used in vivo (within the body), not in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.
Therefore, the Zimmer® Angled Contour Zirconia Abutment is a medical device, but it falls under the category of a dental prosthetic component, not an IVD.
N/A
Intended Use / Indications for Use
The Zimmer® Angled Contour Zirconia Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit restoration in anterior and pre-molar regions.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The new Abutments have sa prepared margin and cone. The Abutments feature a pre-defined offset margin that is lower on the buccal aspect and higher on the lingual aspect to minimize the need to further prepare the Abutment by user. The cone portion of the Abutment is set at a 17 degree andle.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
Zimmer Patient Specific Abutment, Internal Hex, Ceramic
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.)
0