Cleared Traditional

K001623 - SCULPTURE FLOW (FDA 510(k) Clearance)

K001623 · Jeneric/Pentron, Inc. · Dental device

Jul 2000

Decision

46d

Days

Class 2

Risk

K001623 is an FDA 510(k) clearance for the SCULPTURE FLOW. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on July 11, 2000, 46 days after receiving the submission on May 26, 2000.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K001623 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 26, 2000
Decision Date	July 11, 2000
Days to Decision	46 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF