# K092867: Identium Heavy, Medium, Medium Soft, Light

- Pathway: 510(k) (Traditional)
- Applicant: Kettenbach GmbH & Co. KG
- Decided: Oct 1, 2009 after 13 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: 5 generations back to K943574 (1994). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 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.
- K083701: Panasil Initial Contact and Panasil Tray, Kettenbach GmbH & Co. KG (2009) Summary page 1.
- K041398: GC Fusion, GC America, Inc. (2004) Summary page 1.
- K043471: Fusion Fast, GC America, Inc. (2005) Summary page 1.

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

## Indications for use
Identium Light is to be used as a light-bodied, syringeable impression material in one-step technique (double mix) for: Impressions for Crowns/bridges, inlays/onlays and veneer preparations Reline impressions Impressions for full or partial dentures Identium Medium soft is to be used as a medium-bodied tray or syringeable impression material in one-step technique (monophase or double mix) for: Impressions for crowns/bridges, inlays/onlays and veneer preparations Functional impressions Reline impressions Identium Medium is to be used as a medium-bodied tray or syringeable impression material in one-step technique (monophase or double mix) for: Impressions for crowns/bridges, inlays/onlays and veneer preparations Implant impressions Fixation impressions Functional impressions Identium Heavy is to be used as a heavy-bodied impression material in one-step technique (double mix) for: Impressions for crowns/bridges, inlays/onlays and veneer preparations Functional impressions Impressions for full or partial dentures Implant impressions

Source page: https://510kreport.com/device/K092867
Methodology: https://510kreport.com/methodology