(276 days)
Encode® Patient Specific Dental Abutments made from oral scans provided from Sirona CEREC AC Scanner System and inLab Software v3.65 are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. Encode® Patient Specific Dental Abutments are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.
Encode® Patient Specific Dental Abutments are designed specifically for a patient using a CAD/CAM system. The abutments are designed from a threedimensional intra-oral optical scan or resin model scan and then machined/milled according to the parameters created in a digital file which are derived from the scan. The abutments are manufactured from titanium alloy (Ti 6Al-4V ELI) or biocompatible Zirconia TZP. The abutment design is limited according to BIOMET 3i Specifications, as follows:
| Description | Min. | Max. |
|---|---|---|
| A.) Platform Seating Diameter | 3.4 mm | 6.0mm |
| B.) Gingival Margin Diameter | 3.8mm | 16.0mm |
| C.) Gingival Margin Height External | ||
| Hex 3.4mm Platform | 0.5 mm | N/A |
| C.) Gingival Margin Height Certain | ||
| 3.4mm Platform | 0.25 mm | N/A |
| C.) Gingival Margin Height | ||
| 4.1mm/5mm/6mm | ||
| External Hex /Certain | 0.25 mm | N/A |
| D.) Total Height | 4.75mm | 15.0mm |
| E.) Angulations | 0° | 30° |
The provided text is a 510(k) summary for a medical device (Encode® Patient Specific Dental Abutments). It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain the detailed study information about acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert qualifications, or MRMC studies that you've requested.
The "Performance Data" section merely states: "Validation performed on scanning equipment and software to ensure accuracy of scanning models to produce the intended design as cleared in K032263 & K052648." This is a high-level statement and does not provide specific acceptance criteria or quantitative performance results.
The "Equivalence Data" section emphasizes that the new option of oral scans has the "same intended use and indications, principles of operation, and technological characteristics" as previously cleared devices and that "Validation data demonstrates that the modified process results in a finished device that is just as safe and effective as Encode® Patient Specific Dental Abutments that are currently cleared under K032263 & K052648." Again, this is a qualitative statement of equivalence, not a detailed report of a study proving specific acceptance criteria are met.
Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document focuses on demonstrating substantial equivalence rather than presenting a performance study with detailed acceptance criteria and results.
§ 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.)