# K040465: Latit Flow

- Pathway: 510(k) (Traditional)
- Applicant: Ab Ardent
- Decided: Jul 20, 2004 after 148 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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
LATIT FLOW is to be used as a filling material for restoring function to teeth that have lost portions due to caries: Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class lII, IV Class V restorations, cervical caries, root erosion, wedge shaped defects. Small posterior restorations, Class I, Mini cavities, minimal invasion dentistry Veneering of discolored anterior teeth Splinting of mobile teeth. Preventive restorations in molars and premolars. Repair of composite and ceramic veneers. Luting of porcelain and composite veneers As first layer of Class I or II restorations Contra indications: The placement of LATIT FLOW is contraindicated If a dry working field cannot be established or if the stipulated technique cannot be applied. If the patient is known to be allergic to the components of LATIT FLOW.

Source page: https://510kreport.com/device/K040465
Methodology: https://510kreport.com/methodology