Cleared Traditional

Pulpdent (Activa) Pit and Fissure Sealant with MCP

K172169 · Pulpdent Corporation · Dental
Jan 2018
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K172169 is an FDA 510(k) clearance for the Pulpdent (Activa) Pit and Fissure Sealant with MCP, a Sealant, Pit And Fissure, And Conditioner (Class II — Special Controls, product code EBC), submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on January 5, 2018, 171 days after receiving the submission on July 18, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3765.

Submission Details

510(k) Number K172169 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2017
Decision Date January 05, 2018
Days to Decision 171 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBC — Sealant, Pit And Fissure, And Conditioner
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3765

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