Cleared Traditional

K192178 - R&D Series Nova Compo N (FDA 510(k) Clearance)

K192178 · Imicryl Dis Malzemeleri Sanayi VE Ticaret AS · Dental device

Dec 2019

Decision

130d

Days

Class 2

Risk

K192178 is an FDA 510(k) clearance for the R&D Series Nova Compo N. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS (Konya, TR). The FDA issued a Cleared decision on December 20, 2019, 130 days after receiving the submission on August 12, 2019.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K192178 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 12, 2019
Decision Date	December 20, 2019
Days to Decision	130 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF