510(k) K963746

IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID by Whitehill Oral Technologies, Inc. — Product Code JES

K963746 is an FDA 510(k) premarket notification submitted by Whitehill Oral Technologies, Inc. for the device "IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID". The FDA issued a decision of Substantially Equivalent on December 12, 1996. The device falls under product code JES (Floss, Dental), a Class I device regulated under 21 CFR 872.6390. Whitehill Oral Technologies, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1996
Date Received
September 17, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Floss, Dental
Device Class
Class I
Regulation Number
872.6390
Review Panel
DE
Submission Type