Medical Device Manufacturer · US , Watertown , MA

Pulpdent Corporation - FDA 510(k) Cleared Devices

32 submissions · 32 cleared · Since 2002

Recent clearances: ACTIVA PRESTO PACK, OBA-MCP, Orthodontic Bracket Adhesive with MCP, Pulpdent (Activa) Pit and Fissure Sealant with MCP

Total

Cleared

Denied

Pulpdent Corporation has 32 FDA 510(k) cleared dental devices. Based in Watertown, US.

Last cleared in 2021. Active since 2002.

Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Medtek, LLC and Lewis Berk.

Pulpdent Corporation is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Pulpdent Corporation

32 devices

1-12 of 32

OBA-MCP, Orthodontic Bracket Adhesive with MCP

K173020 · DYH

Dental · 111d

Cleared Jan 05, 2018

Pulpdent (Activa) Pit and Fissure Sealant with MCP

K172169 · EBC

Dental · 171d

Cleared Apr 01, 2016

Pulpdent Solo Flowable Composite with MCP

EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Apr 27, 2026

Pulpdent Corporation - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Pulpdent Corporation

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