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510(k) Data Aggregation
(562 days)
PREMIUM-SHELTA Abutments are intended to be used in conjunction with PREMUM-SHELTA Implants Systems in fully edentulous or partially edentulous maxillary and/or mandibular arches. PREMIUM-SHELTA Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment screw is intended to secure the abutment to the endosseous implant. PREMIUM-SHELTA Abutments are compatible with PREMIUM-SHELTA Implants Systems
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I am sorry, but the provided text is a cover letter from the FDA regarding a 510(k) premarket notification for "PREMIUM-SHELTA Prosthetic Components". It also includes the "Indications for Use" for these components.
This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The text focuses on regulatory approval and general controls for a medical device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
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(138 days)
PREMIUM Implant Systems -SHELTA Implant Systems are intended for both one- and two-stage surgical procedures. PREMIUM Implant Systems-SHELTA Implant Systems are intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar. Abutments: PREMIUM-SHELTA Abutments are intended to be used in conjunction with a PREMIUM-SHELTA Implants Systems in fully edentulous or partially edentulous maxillary and/or mandibular arches. The PREMIUM-SHELTA Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. PREMIUM-SHELTA Abutments are compatible with PREMIUM-SHELTA Implants Systems.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding dental implants and abutments. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
Therefore, I cannot extract the requested information from this document. This document is primarily an FDA clearance letter, confirming that the device is substantially equivalent to a legally marketed predicate device. It does not detail the technical performance studies of the device beyond its stated indications for use.
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