Cleared Traditional

ACTIVA PRESTO PACK

K210045 · Pulpdent Corporation · Dental
Sep 2021
Decision
257d
Days
Class 2
Risk

About This 510(k) Submission

K210045 is an FDA 510(k) clearance for the ACTIVA PRESTO PACK, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on September 22, 2021, 257 days after receiving the submission on January 8, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K210045 FDA.gov
FDA Decision Cleared SESE
Date Received January 08, 2021
Decision Date September 22, 2021
Days to Decision 257 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690