S.S. White Technologies, Models 6500-D,6500-E, and 6500-F

FDA 510(k) K984415 · S.S. White Technologies, Inc.

Substantially Equivalent

510(k) numberK984415

Submission

Device name
S.S. White Technologies, Models 6500-D,6500-E, and 6500-F
Applicant
S.S. White Technologies, Inc.
Piscataway, NJ, US
Received
December 10, 1998
Decision date
September 29, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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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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

Questions and answers

When was S.S. White Technologies, Models 6500-D,6500-E, and 6500-F cleared by the FDA?

S.S. White Technologies, Models 6500-D,6500-E, and 6500-F (K984415) received a 510(k) decision of Substantially Equivalent on September 29, 1999, 293 days after the submission was received.

What is the product code of K984415?

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