# K020287: Dentition Integrating Material

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Apr 12, 2002 after 74 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices 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) Pulpdent Flows-Rite: named in the summary without a submission number
- (no number) Pulpdent Seal-Rite Pit and Fissure Sealant: named in the summary without a submission number
- (no number) Pulpdent Seal-Rite Low Viscosity Pit and Fissure Sealant: named in the summary without a submission number
- (no number) Pulpdent Seal-Rite UDMA: named in the summary without a submission number
- (no number) Kuraray Clear-Fil: named in the summary without a submission number
- (no number) Kerr OptiBond Solo Plus 3: named in the summary without a submission number

## Most influential descendants
- K172169: Pulpdent (Activa) Pit and Fissure Sealant with MCP (2018), 1 descendant of its own
- K190998: BA Pit & Fissure Sealant (2019), 0 descendants of its own
- K113818: Embrace Wetbond Pit and Fissure Sealant, Low Fill (2012), 0 descendants of its own
- K113617: Spee-Dee Patch (2012), 0 descendants of its own

## Indications for use
Pulpdent Dentition Integrating Material is a fluoride-releasing. light-cured, resin-based material that bonds tightly to dentition and is used to fill and seal the pits and fissures in teeth.

Source page: https://510kreport.com/device/K020287
Methodology: https://510kreport.com/methodology