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510(k) K863013

ISOLAX PEDAL SET by Sds Dental, Inc.

K863013 is an FDA 510(k) premarket notification submitted by Sds Dental, Inc. for the device "ISOLAX PEDAL SET". The FDA issued a decision of Substantially Equivalent on October 1, 1986. Sds Dental, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1986
Date Received
August 8, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Sds Dental, Inc.

  • K990546 — DELSONIC 2000 (November 5, 1999)
  • K990545 — JETSONIC 2000 (August 11, 1999)
  • K964619 — DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) (January 22, 1997)
  • K902864 — SURGICAL LIGHTING-CENTRA 450 (September 10, 1990)
  • K902865 — BAUMER SURGICAL TABLE (September 10, 1990)
  • K863011 — DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II (October 10, 1986)
  • K863016 — DENTATUS L 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)

FDA data resources