# K063228: Surface Coat

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray America, Inc.
- Decided: Dec 8, 2006 after 44 days
- Product code: EBD (Coating, Filling Material, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K931812 (1993). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030354: Biscover Liquid Polish Kit, Biscover Liquid Polish and Biscover Viscosity Modifier, Bisco, Inc. (2003) Summary page 1.
- K043168: Biscover LV, Bisco, Inc. (2005) Summary page 1.
- K960464: C & B Metabond (Modification), Parkell, Inc. (1996) Summary page 1.
- K012737: Chroma Zone Color Stain, Kuraray Medical, Inc. (2001) Summary page 1.
- K032455: Panavia F 2.0, Kuraray Medical, Inc. (2003) Summary page 1.

## Indications for use
SURFACE COAT is used to glaze/polish following restorations: - Direct and indirect composite resins - Acrylic provisional crowns and bridges - Acrylic appliances - Glass ionomers and resin-modified glass ionomers

Source page: https://510kreport.com/device/K063228
Methodology: https://510kreport.com/methodology