Cleared Traditional

TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS

K924645 · Unitek Corp. · Dental

Nov 1992

Decision

72d

Days

Class 1

Risk

About This 510(k) Submission

K924645 is an FDA 510(k) clearance for the TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS, a Plier, Orthodontic (Class I — General Controls, product code JEX), submitted by Unitek Corp. (Monrovia, US). The FDA issued a Cleared decision on November 25, 1992, 72 days after receiving the submission on September 14, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number	K924645 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 14, 1992
Decision Date	November 25, 1992
Days to Decision	72 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF