# K161989: PREMIUM Implant Systems SHELTA Implant Systems

- Pathway: 510(k) (Traditional)
- Applicant: Sweden & Martina S.P.A.
- Decided: Feb 1, 2018 after 562 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Abutments: PREMIUM-SHELTA Abutments are intended to be used in conjunction with PREMIUM-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. The abutment screw is intended to secure the abutment to the endosseous implant. PREMIUM-SHELTA Abutments are compatible with PREMIUM-SHELTA Implants Systems

Source page: https://510kreport.com/device/K161989
Methodology: https://510kreport.com/methodology