Cleared Traditional

K971594 - FLOW-RITE
(FDA 510(k) Clearance)

K971594 · Pulpdent Corp. · Dental

Sep 1997

Decision

134d

Days

Class 2

Risk

K971594 is an FDA 510(k) clearance for the FLOW-RITE. This device is classified as a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF).

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on September 12, 1997, 134 days after receiving the submission on May 1, 1997.

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

Submission Details

510(k) Number	K971594 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 1997
Decision Date	September 12, 1997
Days to Decision	134 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF