Cleared Traditional

K190272 - Bluephase PowerCure
(FDA 510(k) Clearance)

K190272 · Ivoclar Vivadent, AG · Dental

Jul 2019

Decision

145d

Days

Class 2

Risk

K190272 is an FDA 510(k) clearance for the Bluephase PowerCure, a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ), submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on July 3, 2019, 145 days after receiving the submission on February 8, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number	K190272 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 08, 2019
Decision Date	July 03, 2019
Days to Decision	145 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF