# K221255: SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Corporation
- Decided: Aug 31, 2022 after 121 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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 K940459 (1994). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163207: Filtek One Bulk Fill Restorative, 3M Company (2016) Summary page 4.
- K120453: Filtek Bulk Fill Flowable Restorative, 3M Espe Dental Products (2012) Summary page 4.

## Indications for use
The SimpliShade Bulk Fill is indicated for: - Direct placement of anterior and posterior restorations. - Core build-ups. - Repair of defects in restorations. The SimpliShade Bulk Fill Flow is indicated for: - Base/liner under Class I and Class II direct restorations. - Pit and fissure sealant. - Restoration of small cavities. - Class ff and V restorations. - Blocking out undercuts. - Small core build-ups. - Repair of resin and acrylic provisional restorations.

Source page: https://510kreport.com/device/K221255
Methodology: https://510kreport.com/methodology