# K140144: Benda Wedge

- Pathway: 510(k) (Traditional)
- Applicant: Centrix, Inc.
- Decided: Jul 8, 2014 after 167 days
- Product code: EJB (Handle, Instrument, Dental)
- 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
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) Wedge Wands, G-Wedges: named in the summary without a submission number
- (no number) Pascord, Siltrax: named in the summary without a submission number

## Indications for use
Benda Wedge is an inter-proximal wedge coated with an astringent to be used in combination with other devices to temporarily retain composite or amalgam restorative material as well as to control gingival bleeding during dental restorations.

Source page: https://510kreport.com/device/K140144
Methodology: https://510kreport.com/methodology