Cleared Traditional

K001823 - LINKMAX (FDA 510(k) Clearance)

K001823 · GC America, Inc. · Dental device

Aug 2000

Decision

61d

Days

Class 2

Risk

K001823 is an FDA 510(k) clearance for the LINKMAX. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on August 16, 2000, 61 days after receiving the submission on June 16, 2000.

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

Submission Details

510(k) Number	K001823 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 16, 2000
Decision Date	August 16, 2000
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement