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510(k) K863009

GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX by Sds Dental, Inc. — Product Code EJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1986
Date Received
August 8, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Articulators
Device Class
Class I
Regulation Number
872.3150
Review Panel
DE
Submission Type

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  • 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)
  • K863012 — MINILAX SET (October 1, 1986)
  • K863015 — ISOPRAT C-III SET/ISOCART III AUXILIARY UNIT (October 1, 1986)
  • K863016 — DENTATUS L SET (October 1, 1986)
  • K863007 — EUROFLEX F-IV, ISOFLEX III (October 1, 1986)

Other clearances for product code EJP

  • K926190 — ALRAND INC. (DENTAL HAND INSTRUMENTS) (January 18, 1994)
  • K896131 — GNATHOMAT ARTICULATOR (December 4, 1989)
  • K892373 — DENTAL PLASTIC BITE FORK (June 12, 1989)
  • K884418 — PREMIER DIE-TRAK ARTICULATOR (November 14, 1988)
  • K872943 — DISPOSABLE ARTICULATOR (August 11, 1987)
  • K854702 — PLASTIC MOUNTING RINGS (March 6, 1986)
  • K833039 — HANDY IIM (October 4, 1983)
  • K811075 — BALANCE ARTICULATOR (May 13, 1981)
  • K810971 — THE GNATOMET (May 5, 1981)
  • K801342 — DISPOSABLE ARTICULATOR (July 8, 1980)