# K012360: LC Temporary Filling

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Sep 6, 2001 after 43 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Fermit N: named in the summary without a submission number
- (no number) Tempfil F: named in the summary without a submission number
- (no number) Tempfil C&B: named in the summary without a submission number
- (no number) Tempfil F-2: named in the summary without a submission number
- (no number) LC Provifill: named in the summary without a submission number

## Indications for use
A light-cured resin intended for use as a temporary restorative material in a tooth prepared to receive an inlay or onlay until such time as the laboratory fabricated final restoration can be inserted into that tooth.

Source page: https://510kreport.com/device/K012360
Methodology: https://510kreport.com/methodology