Cleared Traditional

K023819 - FIBERFILL SGP
(FDA 510(k) Clearance)

K023819 · Pentron Clinical Technologies · Dental device

Mar 2003

Decision

131d

Days

Class 1

Risk

K023819 is an FDA 510(k) clearance for the FIBERFILL SGP. This device is classified as a Gutta-percha (Class I - General Controls, product code EKM).

Submitted by Pentron Clinical Technologies (Wallingford, US). The FDA issued a Cleared decision on March 26, 2003, 131 days after receiving the submission on November 15, 2002.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3850.

Submission Details

510(k) Number	K023819 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 15, 2002
Decision Date	March 26, 2003
Days to Decision	131 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement