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510(k) K990545

JETSONIC 2000 by Sds Dental, Inc. — Product Code KOJ

K990545 is an FDA 510(k) premarket notification submitted by Sds Dental, Inc. for the device "JETSONIC 2000". The FDA issued a decision of Substantially Equivalent on August 11, 1999. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080. Sds Dental, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1999
Date Received
February 22, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airbrush
Device Class
Class II
Regulation Number
872.6080
Review Panel
DE
Submission Type

Other clearances by Sds Dental, Inc.

  • K990546 — DELSONIC 2000 (November 5, 1999)
  • K964619 — DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) (January 22, 1997)
  • K902865 — BAUMER SURGICAL TABLE (September 10, 1990)
  • K902864 — SURGICAL LIGHTING-CENTRA 450 (September 10, 1990)
  • K863011 — DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II (October 10, 1986)
  • K863016 — DENTATUS L SET (October 1, 1986)
  • K863013 — ISOLAX PEDAL SET (October 1, 1986)
  • K863012 — MINILAX SET (October 1, 1986)
  • K863021 — CM-II, CM-I WATER UNIT (October 1, 1986)
  • K863015 — ISOPRAT C-III SET/ISOCART III AUXILIARY UNIT (October 1, 1986)

Other clearances for product code KOJ

  • K251425 — turbodent touch (May 9, 2025)
  • K063236 — BETA-POWDER (February 16, 2007)
  • K042872 — RONDOFLEX PLUS 360 (November 23, 2004)
  • K033675 — PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER (January 15, 2004)
  • K033215 — PREPAIR (January 9, 2004)
  • K024105 — VELOPEX AQUACUT FLUID ABRASION UNIT (October 9, 2003)
  • K030292 — GROMAN PREPMASTER (April 15, 2003)
  • K021450 — CLINPRO PROPHY POWDER (August 1, 2002)
  • K014188 — NEW PROPHY POWDER (March 15, 2002)
  • K014252 — JETSTREAM (February 19, 2002)

FDA data resources