Cleared Traditional

IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID

K963746 · Whitehill Oral Technologies, Inc. · Dental

Dec 1996

Decision

86d

Days

Class 1

Risk

About This 510(k) Submission

K963746 is an FDA 510(k) clearance for the IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID, 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 December 12, 1996, 86 days after receiving the submission on September 17, 1996. This device falls under the Dental review panel. Regulated under 21 CFR 872.6390.

Submission Details

510(k) Number	K963746 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 17, 1996
Decision Date	December 12, 1996
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement