# K240823: els extra low shrinkage® composite & els extra low shrinkage® flow

- Pathway: 510(k) (Abbreviated)
- Applicant: Saremco Dental AG
- Decided: Jun 27, 2024 after 93 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K083610 (2008). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213339: DENU Composite Resin, DENU Flow Resin, Hdi, Inc. (2022) Summary page 5.

## Indications for use
els extra low shrinkage® composite & els extra low shrinkage® flow are restorative materials intended for the reconstruction or correction of natural dentition. els extra low shrinkage® composite is indicated for: Restoration of class I, II, III, IV and V cavities on anterior and posterior teeth Indirect anterior and posterior restorations including inlays, onlays and veneers Aesthetic corrections of interdental spaces, enamel hypoplasia, discolorations Splinting els extra low shrinkage® flow is indicated for: Restorations with minimally invasive preparation technique Restorations of small cavities and extended fissure sealing Alternate restorations for undercut cavities Restorations of class III - V including wedged shaped defects and cervical caries Repair of fillings, veneers and methacrylate-based temporary restorations First layer of fillings for Class I and II Interlocking of loosened teeth Adhesive attachment of indirect composite and ceramic restorations

Source page: https://510kreport.com/device/K240823
Methodology: https://510kreport.com/methodology