# K013895: Tempfil

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Feb 4, 2002 after 73 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) TempFil F - 2: named in the summary without a submission number

## Indications for use
The intended use of TempFil is for temporary filling of inlay and onlay preparations, implant screw and endodontic access openings, and for the emergency replacement of lost fillings.

Source page: https://510kreport.com/device/K013895
Methodology: https://510kreport.com/methodology