# K090992: Well-Paste

- Pathway: 510(k) (Traditional)
- Applicant: Vericom Co., Ltd.
- Decided: Apr 21, 2009 after 14 days
- Product code: KIF (Resin, Root Canal Filling)
- Device class: 2
- Regulation: 21 CFR 872.3820
- 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 K944945 (1994). 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)
- K032605: Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal Filling, Meta Biomed Co., Ltd. (2003) Summary page 1.

## Indications for use
Well-PasteTM is a biocompatible root canal sealer used for the temporary filling of root canals after endodontic surgery. Well-PasteTM can be used on its own and for vital pulpectomies in deciduous teeth.

Source page: https://510kreport.com/device/K090992
Methodology: https://510kreport.com/methodology