Cleared Traditional

PERIO-MED DENTAL FLOSS

K944034 · Whitehill Oral Technologies, Inc. · Dental

Jul 1995

Decision

357d

Days

Class 1

Risk

About This 510(k) Submission

K944034 is an FDA 510(k) clearance for the PERIO-MED DENTAL FLOSS, a Floss, Dental (Class I — General Controls, product code JES), submitted by Whitehill Oral Technologies, Inc. (Hazlet, US). The FDA issued a Cleared decision on July 25, 1995, 357 days after receiving the submission on August 2, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.6390.

Submission Details

510(k) Number	K944034 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 02, 1994
Decision Date	July 25, 1995
Days to Decision	357 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement