# K974483: NTL-Flow

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Feb 9, 1998 after 75 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. The FDA summary names its predicate without a number.
- (no number) Aeliteflo: named in the summary without a submission number

## Indications for use
1. Anterior esthetic restorative material for Class I, IV, and V as well as conservative Class I restorations not involving opposing occlusal wear for direct or indirect use. 2. Direct Esthetic veneer restorative for masking stains and developmental anomalies. 3 Pit and fissure sealant. 4, core build-up material to replace missing tooth structure. 5. Dental cement/luting agent and dental liner. 6. Composite/porcelain repair material.

Source page: https://510kreport.com/device/K974483
Methodology: https://510kreport.com/methodology