# K954281: Panasil Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: Roydent Dental Products, Inc.
- Decided: Jun 24, 1996 after 285 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
No predicates in its family tree.
23 later devices descend from it; 4 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K082560: Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and Contact (2008), 17 descendants of its own
- K133527: Suflex Putty, Suflex Heavy, Suflex Mono, Suflex Light (2014), 12 descendants of its own
- K151262: Hyflex Heavy, Hyflex Mono, Hyflex Light (2015), 11 descendants of its own
- K170736: HySil Impression Materials (2017), 10 descendants of its own
- K081120: Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan Bite Registration Materials (2008), 3 descendants of its own

Source page: https://510kreport.com/device/K954281
Methodology: https://510kreport.com/methodology