# K102133: GIRAFFE2

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Corporation
- Decided: Oct 7, 2010 after 70 days
- Product code: MVL (Cord, Retraction)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Expa-syl: named in the summary without a submission number

## Indications for use
Giraffe2 is a paste containing a hemostatic agent which is intended to be used for the temporary retraction and hemastasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.

Source page: https://510kreport.com/device/K102133
Methodology: https://510kreport.com/methodology