(106 days)
The PRE-MILLED Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
It is compatible with the following systems:
All digitally designed abutments for use with the PRE-MILLED Abutments must be designed and milled through the 3Shape CAD/CAM System and are intended to be sent to a validated milling center for manufacture.
The PRE-MILLED Abutment is compatible with the following devices:
Zimmer 3.1mmD Dental Implant System (K142082) Implant Body Diameter 3.1/ Implant Platform Diameter 2.9 / Internal Hex
Screw Vent® and Tapered Screw Vent® (K013227)
Implant Body Diameter 3.7/ Implant Platform Diameter 3.5 / Internal Hex
Implant Body Diameter 4.1/ Implant Platform Diameter 3.5 / Internal Hex
Implant Body Diameter 4.7/ Implant Platform Diameter 4.5 / Internal Hex
Implant Body Diameter 6.0/ Implant Platform Diameter 5.7 / Internal Hex
The PRE-MILLED Abutment is used in fabricating a patient-specific abutment in titanium alloy. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. It is made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136).
The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system.
Mechanical resistance of the implant-abutment connection is essential to ensure the correct longterm functional performance of the complete dental restoration. Dimensional compatibility and mechanical performance of abutments and screws together with the underlying implant are of primary importance. These concepts are the basis upon which the system design characteristics and functional performance are established.
The PRE-MILLED is a device that can only be sold, distributed, or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices.
The proposed abutments are available in internal connection, and are compatible with Zimmer 3.1mmD Dental Implant System (K142082) and Screw Vent® and Tapered Screw Vent® (K013227).
The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) premarket notification for a medical device (PRE-MILLED Abutment) and focuses on demonstrating substantial equivalence to a predicate device.
The document discusses:
- Device Description: The PRE-MILLED Abutment is used for fabricating patient-specific abutments from titanium alloy, designed via CAD/CAM, and connected to an endosseous dental implant.
- Indications for Use: Support for single or multiple tooth prostheses in partially or fully edentulous patients, compatible with specific Zimmer implant systems.
- Non-clinical Testing:
- Fatigue Test (ISO 14801:2016)
- End User Steam Sterilization Test (ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010)
- Biocompatibility tests (ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010)
- Dimensional analysis and reverse engineering of the implant-to-abutment connection platform.
- Conclusion: The non-clinical tests demonstrated substantial equivalence to the primary predicate device, meeting the criteria of the standards. Clinical testing was deemed unnecessary.
However, the document does not explicitly state specific acceptance criteria (e.g., a numerical threshold for fatigue life) and then present detailed results proving those criteria were met. It generally states that "The results of the above tests have met the criteria of the standard and demonstrated the substantial equivalence with the primary predicate."
Therefore, I cannot provide the requested table and detailed study information because it is not present in the provided text.
§ 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.)