Cleared Traditional

Allcem, Allcem Core

K183465 · Dentscare Ltda · Dental
Nov 2019
Decision
323d
Days
Class 2
Risk

About This 510(k) Submission

K183465 is an FDA 510(k) clearance for the Allcem, Allcem Core, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Dentscare Ltda (Joinville, BR). The FDA issued a Cleared decision on November 2, 2019, 323 days after receiving the submission on December 14, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K183465 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2018
Decision Date November 02, 2019
Days to Decision 323 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275