# K982564: Delton FS Direct Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Oct 6, 1998 after 75 days
- Product code: EBC (Sealant, Pit And Fissure, And Conditioner)
- Device class: 2
- Regulation: 21 CFR 872.3765
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951296 (1995). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951296: Delton F Pit & Fissure Sealant, Dentsply Intl. (1995). Our OCR of the scanned summary read K851296, FDA’s number for Implantable Electrode Lead 030-269 Using Polyureth (Telectronics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “DELTON® Plus Direct Delivery System”.

## Most influential descendants
- K992516: Dyract Seal Compomer Pit & Fissure Sealant (1999), 0 descendants of its own
- K991909: Delton FS with Fluoride Pit & Fissure Sealant (1999), 0 descendants of its own

## Indications for use
The DELTON® FS DIRECT DELIVERY SYSTEM is used for preventive sealing of pits and fissures in the primary and secondary dentition in combination with the acid-etch technique.

Source page: https://510kreport.com/device/K982564
Methodology: https://510kreport.com/methodology