# K142242: PREMIUM, SHELTA Implant Systems

- Pathway: 510(k) (Traditional)
- Applicant: Sweden & Martina S.P.A.
- Decided: Feb 2, 2015 after 173 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K170100: CreoDent Solidex Customized Abutment and Screw (2017), 0 descendants of its own

## Indications for use
PREMIUM Implant Systems-SHELTA Implant Systems (Premium Straight, 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 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/K142242
Methodology: https://510kreport.com/methodology