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

32

Total

32

Cleared

0

Denied

FDA 510(k) Regulatory Record - Pulpdent Corporation Dental ✕

32 devices

1-12 of 32

Cleared Sep 22, 2021

ACTIVA PRESTO PACK

Cleared Jan 17, 2018

OBA-MCP, Orthodontic Bracket Adhesive with MCP

Cleared Jan 05, 2018

Pulpdent (Activa) Pit and Fissure Sealant with MCP

Cleared Apr 01, 2016

Pulpdent Solo Flowable Composite with MCP

Cleared Mar 29, 2013

Cleared Dec 07, 2012

RMGI LOW VISCOSITY

Cleared Jun 08, 2012

Cleared Apr 05, 2012

Cleared Mar 30, 2012

ETCH-RITE SUPREME

Cleared Mar 21, 2012

EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL

Cleared Mar 05, 2012

Cleared Mar 02, 2012

Data Source

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

Last updated: Apr 27, 2026