# K133400: Flash Bite

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe AG
- Decided: Mar 6, 2014 after 120 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K812116 (1981). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991008: Dimension Bite, Espe Dental AG (1999) Summary page 2.
- K131404: Flash AR Penta / Flash AR Penta Quick, 3M Deutschland GmbH (2013) Summary page 2.

## Indications for use
Bite registration.

Source page: https://510kreport.com/device/K133400
Methodology: https://510kreport.com/methodology