# K143382: DentiAnn Smart Sil

- Pathway: 510(k) (Traditional)
- Applicant: Seilglobal Co., Ltd.
- Decided: Feb 23, 2015 after 90 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K102836 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102836: Bonasil a+ Impression Materials, Dmp, Ltd. (2011) Summary page 4.

## Indications for use
DentiAnn Light-body is to be used as a light body material for: ▪ Two step putty/wash technique ▪ Single step putty/wash technique ▪ Functional peripheries ▪ Reline impressions ▪ Crown/bridge work ▪ Inlays, Onlays DentiAnn Heavy-body is to be used as a heavy body material for: ▪ Two step putty/wash technique ▪ Single step putty/wash technique ▪ Functional peripheries ▪ Crown/bridge work ▪ Inlays, Onlays SmartSil-Putty is to be used as a preliminary material for: ▪ Two step putty/wash technique ▪ Single step putty/wash technique ▪ Functional peripheries ▪ Crown/bridge work ▪ Inlays, Onlays SmartSil-Bite is to be used as a light body material for: ▪ Making accurate occlusal registrations ▪ Standards bite registrations in the end bite position. ▪ Key material for needle point registration. ▪ Production of small model segments

Source page: https://510kreport.com/device/K143382
Methodology: https://510kreport.com/methodology