Cleared Traditional

K012174 - ERIS LAYERING MATERIALS
(FDA 510(k) Clearance)

K012174 · Ivoclar North America, Inc. · Dental

Aug 2001

Decision

46d

Days

Class 2

Risk

K012174 is an FDA 510(k) clearance for the ERIS LAYERING MATERIALS, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on August 27, 2001, 46 days after receiving the submission on July 12, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K012174 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 2001
Decision Date	August 27, 2001
Days to Decision	46 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement