# K991464: Dental 200, Dental 300, Dental 400, Models E-20, E-60, E-50

- Pathway: 510(k) (Traditional)
- Applicant: Fisma, Inc.
- Decided: Jul 20, 1999 after 84 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- 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) Arago II, Argon Laser: named in the summary without a submission number
- (no number) Elite Family of Lasers, KTP Green: named in the summary without a submission number

## Indications for use
Laser-assisted Bleaching/Whitening of the teeth. Illumination purposes for the adjunctive use in caries detection and endodontic orifice location. Curing of all light sensitive bonding materials including: Pit and fissure sealants, composite restorations, endodontic composite cores, composite cements for porcelain facings and inlays, periodontal splint material, and prosthetic reline and repair material.

Source page: https://510kreport.com/device/K991464
Methodology: https://510kreport.com/methodology