Cleared Traditional

K032470 - MULTILINK (FDA 510(k) Clearance)

K032470 · Ivoclar Vivadent, Inc. · Dental device

Nov 2003

Decision

86d

Days

Class 2

Risk

K032470 is an FDA 510(k) clearance for the MULTILINK. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on November 5, 2003, 86 days after receiving the submission on August 11, 2003.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number	K032470 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 11, 2003
Decision Date	November 05, 2003
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement