Gelato Prophylaxis Paste

FDA 510(k) K042048 · Deepak Products, Inc.

Substantially Equivalent

510(k) numberK042048

Submission

Device name
Gelato Prophylaxis Paste
Applicant
Deepak Products, Inc.
Miami, FL, US
Received
July 30, 2004
Decision date
October 26, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EJR – Agent, Polishing, Abrasive, Oral Cavity
Device class
Class I (low risk)
Regulation
21 CFR 872.6030
Specialty
Dental

Other 510(k)s with product code EJR

510(k)DeviceApplicantDecision
K171189AIR-FLOW PLUS Prophylaxis powderEJR · Traditional E.M.S Electro Medical Systems S.A09/11/2017SE
K131760Whip Mix Preppies PlusEJR · Traditional Whip-Mix Corp.03/26/2014SE
K121698Nupro Sensodyne Prophylaxis Paste with NovaminEJR · Traditional Dentsply International, Inc.08/06/2012SE
K103114Osspray Sylc CREJR · Traditional Osspray, Ltd.03/14/2011SE
K102053Butler Calci-Flor Prophylaxis PasteEJR · Traditional Sunstar Americas, Inc.02/03/2011SE
K101104Remin ProEJR · Traditional Voco GmbH10/21/2010SE
K100539Preventech Prophylaxis Paste with FluorideEJR · Traditional Preventive Technologies, Inc.06/17/2010SE
K070854GC Mi Paste PlusEJR · Special GC America, Inc.04/12/2007SE
K062502Osspray Cleaning CompoundEJR · Traditional Ospray, Ltd.12/15/2006SE
K062166Enamel ProEJR · Traditional Premier Dental Products Co.11/21/2006SE

Questions and answers

When was Gelato Prophylaxis Paste cleared by the FDA?

Gelato Prophylaxis Paste (K042048) received a 510(k) decision of Substantially Equivalent on October 26, 2004, 88 days after the submission was received.

What is the product code of K042048?

The FDA product code is EJR – Agent, Polishing, Abrasive, Oral Cavity, a Class I (low risk) device regulated under 21 CFR 872.6030.