Groman Prepmaster

FDA 510(k) K030292 · Groman, Inc.

Substantially Equivalent

510(k) numberK030292

Submission

Device name
Groman Prepmaster
Applicant
Groman, Inc.
Margate, FL, US
Received
January 28, 2003
Decision date
April 15, 2003
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

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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
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
K014249JetpolisherKOJ · Traditional Deldent , Ltd.02/19/2002SE

Questions and answers

When was Groman Prepmaster cleared by the FDA?

Groman Prepmaster (K030292) received a 510(k) decision of Substantially Equivalent on April 15, 2003, 77 days after the submission was received.

What is the product code of K030292?

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