Cleared Traditional

DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST

K033045 · American Green Dent. Mfg, Inc. · Dental

Dec 2003

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K033045 is an FDA 510(k) clearance for the DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST, a Alloy, Metal, Base (Class II — Special Controls, product code EJH), submitted by American Green Dent. Mfg, Inc. (Los Angeles, US). The FDA issued a Cleared decision on December 23, 2003, 85 days after receiving the submission on September 29, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number	K033045 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2003
Decision Date	December 23, 2003
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement