# K111978: Sulcus Blue

- Pathway: 510(k) (Traditional)
- Applicant: Produits Dentaires Pierre Rolland
- Decided: Oct 13, 2011 after 93 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
Longest line of descent: 2 generations back to K050180 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082116: Hemostasyl Paste, Satelec (2008) Summary page 1.
- K050180: Expa-Syl, Produits Dentaires Pierre Rolland (2005) Summary page 1.
- K083695: Traxodent, Premier Dental Products Co. (2009) Summary page 1.

## Indications for use
SULCUSBLUE is a paste containing aluminium chloride which is intended to be used, in association with compression caps, for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.

Source page: https://510kreport.com/device/K111978
Methodology: https://510kreport.com/methodology