Cleared Abbreviated

K183380 - Tetric PowerFill
(FDA 510(k) Clearance)

K183380 · Ivoclar Vivadent, AG · Dental
Mar 2019
Decision
98d
Days
Class 2
Risk

K183380 is an FDA 510(k) clearance for the Tetric PowerFill, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on March 14, 2019, 98 days after receiving the submission on December 6, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K183380 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2018
Decision Date March 14, 2019
Days to Decision 98 days
Submission Type Abbreviated
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