# K172169: Pulpdent (Activa) Pit and Fissure Sealant with MCP

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Jan 5, 2018 after 171 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 K020287 (2002). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020287: Dentition Integrating Material, Pulpdent Corporation (2002) Summary page 4.

## Most influential descendants
- K190998: BA Pit & Fissure Sealant (2019), 0 descendants of its own

## Indications for use
Pulpdent’s Activa Pit and Fissure Sealant with MCP is intended to seal pit and fissure depressions/faults in the enamel, in the biting surfaces of teeth. For dental professional use only.

Source page: https://510kreport.com/device/K172169
Methodology: https://510kreport.com/methodology