# K083701: Panasil Initial Contact and Panasil Tray

- Pathway: 510(k) (Special)
- Applicant: Kettenbach GmbH & Co. KG
- Decided: Jan 9, 2009 after 25 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: 4 generations back to K943574 (1994). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082560: Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and Contact, Kettenbach GmbH & Co. KG (2008) Summary page 1.

## Most influential descendants
- K092867: Identium Heavy, Medium, Medium Soft, Light (2009), 1 descendant of its own
- K113279: Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium, Identium Scan Light (2011), 0 descendants of its own

## Indications for use
Panasilinitial contact (regular, regular fast, light, light fast, x-light, x-light fast) is to be used as a syringeable impression material for: Two-step putty-wash impression technique. One-step putty-wash impression technique. One-step impression technique using a foil (plastic putty spacer). One-step impression technique (simultaneous technique) using dual viscosities. Reline impressions. Fabricating full or partial dentures. Panasiltray (fast 1:1, soft fast 5:1, soft fast 1:1) is to be used as a heavy-bodied material for: one-step impression technique (simultaneous technique) using single or dual viscosities. Two-step impression technique using dual viscosities. Functional impressions.

Source page: https://510kreport.com/device/K083701
Methodology: https://510kreport.com/methodology