# K071858: Dental Matrix Band

- Pathway: 510(k) (Traditional)
- Applicant: Fly Cast Technologies, Inc.
- Decided: Aug 31, 2007 after 57 days
- Product code: DZN (Instruments, Dental Hand)
- 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) Dentsply, Inc., Dental Matrix Band: named in the summary without a submission number

## Indications for use
A dental matrix band is a non-sterile single use disposable device intended to be place around a tooth to keep filling material from bonding onto the other tooth. Matrix bands are used to form missing walls of prepared teeth. They shape and confine restorative materials to areas prepared to receive restorations.

Source page: https://510kreport.com/device/K071858
Methodology: https://510kreport.com/methodology