Search Results

PREMIUM Implant Systems-SHELTA Implant Systems (Premium TG, Premium TG, Premium SP, Shelta and Shelta SL) 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 document is an FDA 510(k) clearance letter for dental implant systems. It does not contain information regarding acceptance criteria, device performance metrics, or study details (like sample size, ground truth establishment, expert qualifications, or multi-reader studies). The letter primarily addresses the substantial equivalence determination for the device based on its indications for use.

Therefore, I cannot provide the requested information from this document. The document focuses on regulatory approval rather than technical performance studies.

Ask a specific question about this device