Cleared Traditional

D-SIGN VI (R&D PROJECT DW266#9)

K990235 · Ivoclar North America, Inc. · Dental

Mar 1999

Decision

35d

Days

Class 2

Risk

About This 510(k) Submission

K990235 is an FDA 510(k) clearance for the D-SIGN VI (R&D PROJECT DW266#9), a Alloy, Metal, Base (Class II — Special Controls, product code EJH), submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on March 1, 1999, 35 days after receiving the submission on January 25, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number	K990235 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 25, 1999
Decision Date	March 01, 1999
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement