# K113279: Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium, Identium Scan Light

- Pathway: 510(k) (Special)
- Applicant: Kettenbach GmbH & Co. KG
- Decided: Nov 14, 2011 after 7 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: 6 generations back to K943574 (1994). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092867: Identium Heavy, Medium, Medium Soft, Light, Kettenbach GmbH & Co. KG (2009) Summary page 2.
- K082560: Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and Contact, Kettenbach GmbH & Co. KG (2008) Summary page 2.
- K081120: Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan Bite Registration Materials, Kettenbach GmbH & Co. KG (2008) Summary page 2.

## Indications for use
Identium® Heavy (regular 1:1, fast 1:1) 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 Identium® Medium (regular 1:1, fast 1:1) 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 * Fixation impressions * Implant impressions Identium® Scan Heavy (regular 1:5) 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 Identium® Scan Medium (regular 1:5) 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 * Fixation impressions * Implant impressions Identium® Scan Light (regular 1:1) is to be used as a syringeable light-bodied 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

Source page: https://510kreport.com/device/K113279
Methodology: https://510kreport.com/methodology