# K981990: MRS-400, Maxi 400, MRSL-400, Maxi 400L

- Pathway: 510(k) (Traditional)
- Applicant: D.B.I. America Corp.
- Decided: Jun 22, 1998 after 14 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The dental handpiece is intended to be used by dentists to prepare dental cavities for restorations such as fillings and for cleaning teeth.

Source page: https://510kreport.com/device/K981990
Methodology: https://510kreport.com/methodology