Cleared Traditional

DENTAL MATRIX BAND

K071858 · Fly Cast Technologies, Inc. · Dental

Aug 2007

Decision

57d

Days

Class 1

Risk

About This 510(k) Submission

K071858 is an FDA 510(k) clearance for the DENTAL MATRIX BAND, a Instruments, Dental Hand (Class I — General Controls, product code DZN), submitted by Fly Cast Technologies, Inc. (Grayslake, US). The FDA issued a Cleared decision on August 31, 2007, 57 days after receiving the submission on July 5, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number	K071858 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 05, 2007
Decision Date	August 31, 2007
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF