(100 days)
The Vericore Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. In is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The abutment is placed over the implant and is mounted on to the implant with an abutment screw; an abutment adaptor will be added between the implant and the abutment. The abutment adaptor is intended to interface between the abutment and the implant allowing the abutment to meet with and be sealed to the parts of the implan that can not be milled into the abutment.
This device is compatible with the following manufacturers' implant systems: Nobel Biocare, Southern Trilock.
This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.
Also highly angled abutments (i.e. 28 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended foor the posterior region due to limited strength of the implant.
Replace- Narrow (3.5mm), Regular (4.3mm), Wide (5.0mm) and 6mm Southern Trilock - Narrow (3.5mm), Regular (4.3mm) and Wide (5.0mm)
The Devices covered in this submission are abutments which are placed on the dental implant to provide support for a prosthetic restoration.
Vericore Abutments are made from biocompatible yttria-stablized zirconia blocks. The abutment screws and adaptors are made from Titanium grade Ti-6A1-4V for the screws and Grade 4 for the adaptors. The abutment is placed over the implant and is mounted on to the implant with an abutment screw; an abutment adaptor will be added between the implant and the abutment. The abutment adaptor is intended to interface between the abutment and the implant allowing the abutment to meet with and be sealed to the parts of the implant that can not be milled into the abutment. The abutments are compatible with the following implant systems:
Replace- Narrow (3.5mm), Regular (4.3mm), Wide (5.0mm) and 6mm Southern Trilock - Natrow (3.5mm), Regular (4.3mm) and Wide (5.0mm)
The provided text is a 510(k) summary for the Vericore™ Abutment, a dental implant abutment. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study demonstrating device performance.
Therefore, I cannot provide the requested table and study details.
The document primarily focuses on:
- Device Description: What the Vericore Abutment is made of and how it functions.
- Intended Use: The clinical purpose of the abutment.
- Predicate Device: The legally marketed device (Atlantis Zirconia Abutments) to which equivalence is claimed.
- Regulatory Information: FDA’s determination of substantial equivalence and general controls applicable to the device.
There is no mention of any performance studies, clinical trials, or bench tests with specific acceptance criteria or results. The FDA's 510(k) clearance process for devices like this often relies on demonstrating substantial equivalence to a predicate device, sometimes through physical and mechanical testing, but the details of such testing (if performed and submitted) are not present in this summary.
§ 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.)