Jetpolisher

FDA 510(k) K014249 · Deldent , Ltd.

Substantially Equivalent

510(k) numberK014249

Submission

Device name
Jetpolisher
Applicant
Deldent , Ltd.
Petach Tikvah, IL
Received
December 26, 2001
Decision date
February 19, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KOJ – Airbrush
Device class
Class II (moderate risk)
Regulation
21 CFR 872.6080
Specialty
Dental

Other 510(k)s with product code KOJ

510(k)DeviceApplicantDecision
K251425turbodent touchKOJ · Traditional Mectron S.P.A.05/09/2025SE
K063236Beta-PowderKOJ · Traditional Brainbase Corporation02/16/2007SE
K042872Rondoflex Plus 360KOJ · Special Kavo America Corporation11/23/2004SE
K033675Prosmile Air Polisher and Prophylaxis PowderKOJ · Traditional Sirona Dental Systems GmbH01/15/2004SE
K033215PrepairKOJ · Traditional Danville Materials, Inc.01/09/2004SE
K024105Velopex Aquacut Fluid Abrasion UnitKOJ · Traditional Velopex International, Inc.10/09/2003SE
K030292Groman PrepmasterKOJ · Traditional Groman, Inc.04/15/2003SE
K021450Clinpro Prophy PowderKOJ · Traditional 3M Espe AG Dental Products08/01/2002SE
K014188New Prophy PowderKOJ · Traditional Dentsply Intl.03/15/2002SE
K014252JetstreamKOJ · Traditional Deldent , Ltd.02/19/2002SE

More from Deldent , Ltd.

510(k)DeviceDecision
K014252JetstreamKOJ · Traditional 02/19/2002SE
K014245Jetsonic 2000KOJ · Traditional 01/29/2002SE
K014238Delsonic 2000ELC · Traditional 01/24/2002SE
K013969MiniblasterKOJ · Traditional 01/10/2002SE
K011179Deldent Ultrasonic InsertsELC · Traditional 06/05/2001SE

Questions and answers

When was Jetpolisher cleared by the FDA?

Jetpolisher (K014249) received a 510(k) decision of Substantially Equivalent on February 19, 2002, 55 days after the submission was received.

What is the product code of K014249?

The FDA product code is KOJ – Airbrush, a Class II (moderate risk) device regulated under 21 CFR 872.6080.