# K060347: B&L L-Beta, Model WL-B1

- Pathway: 510(k) (Traditional)
- Applicant: B&L Biotech Co., Ltd.
- Decided: Jun 5, 2006 after 115 days
- Product code: EKR (Plugger, Root Canal, Endodontic)
- Device class: 1
- Regulation: 21 CFR 872.4565
- 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 K832654 (1983). 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)
- K042828: Obtura Gutta Percha Delivery System, Model 823-700, Young O/S, LLC (2004) Summary page 1.

## Indications for use
Intended for use by professionally qualified Licensed dentists, endodontists and clinicians to heat gutta percha and to place it into the previously prepared root canals of human teeth, in order to provide a quick and complete obturation of the canal.

Source page: https://510kreport.com/device/K060347
Methodology: https://510kreport.com/methodology