510(k) · Cleared

Cleared

Pulpdent (Activa) Pit and Fissure Sealant with MCP

K172169510(k) TraditionalCleared Jan 5, 2018171-day reviewClass II21 CFR 872.3765

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pulpdent Corporation · EBC Sealant, Pit And Fissure, And Conditioner

Cleared on Jan 5, 2018 as substantially equivalent to K020287 (Pulpdent Corporation, 2002) after a 171-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it.

Decided: Jan 5, 2018
Review: 171 days
Class: Class II
Product code: EBC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K020287 (2002). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK020287 Dentition Integrating MaterialPulpdent Corporation · 2002
This deviceK172169 Pulpdent (Activa) Pit and Fissure Sealant with MCPPulpdent Corporation · 2018
Descendant · cites it directly · 0 of its ownK190998 BA Pit & Fissure SealantApex Dental Materials, Inc. · 2019

Most influential descendants

Showing 1 of 1 · See all

K190998BA Pit & Fissure SealantApex Dental Materials, Inc. · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K020287	Dentition Integrating Material	Pulpdent Corporation	2002	—
0 (this device)	K172169	Pulpdent (Activa) Pit and Fissure Sealant with MCP	Pulpdent Corporation	2018	—
+1	K190998	BA Pit & Fissure Sealant	Apex Dental Materials, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0

FIG. 1 — Lineage of K172169, 2002–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EBC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new EBC device

#1 K243254 Parkell Pit and Fissure Sealantscore 12.8 · 1 generation · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K020287	Dentition Integrating Material Summary page 4 …e: Pit and Fissure Sealant FDA Product Code: EBC, 21 CFR Part 872.3765 PREDICATE DEVICE: Pulpdent’s Embrace Pit and Fissure Sealant/Dentition Integrating Material K020287 Please Note: Pulpdent Dentition Integrating Material was the working name for Pulpdent Embrace Pit and Fissure Sealant, before a…	Pulpdent Corporation	2002	—
†	K153249	Pulpdent Solo Flowable Composite with MCP	Pulpdent Corporation	2016	—

Also cleared against K020287: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K190998	BA Pit & Fissure Sealant	Apex Dental Materials, Inc.	2019	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K190998 (Apex Dental Materials, Inc., 2019) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K020287.

How does its category compare?

All EBC devices

EBC Sealant, Pit And Fissure, And Conditioner: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · EBC

1in 2025

2007high 5 (2010) · low 0 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBC

80in 2011

2007high 115 (2010) · low 80 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EBC

2in 2016

2007high 2 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EBC

6in 2025

2007high 11 (2013) · low 0 (2010)2025

MAUDE reports naming product code EBC, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	3
2008	1	—	0	1
2009	2	—	0	1
2010	5	115	0	0
2011	3	80	0	5
2012	1	—	0	0
2013	1	—	0	11
2014	1	—	0	0
2015	1	—	1	0
2016	1	—	2	0
2017	2	—	0	0
2018	1	—	0	0
2019	2	—	0	0
2020	0	—	0	1
2021	0	—	0	0
2022	0	—	0	1
2023	2	—	0	2
2024	0	—	0	1
2025	1	—	0	6
2026	1	—	0	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K172169 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172169: Pulpdent (Activa) Pit and Fissure Sealant with MCP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172169

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026