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510(k) K863009

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

K863009 is an FDA 510(k) premarket notification submitted by Sds Dental, Inc. for the device "GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX". The FDA issued a decision of Substantially Equivalent on September 25, 1986. The device falls under product code EJP (Articulators), a Class I device regulated under 21 CFR 872.3150. Sds Dental, Inc. has at least 10 other 510(k) clearances on record.

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

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)
  • 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)
  • K863015 — ISOPRAT C-III SET/ISOCART III AUXILIARY UNIT (October 1, 1986)
  • K863012 — MINILAX SET (October 1, 1986)
  • K863016 — DENTATUS L SET (October 1, 1986)
  • K863013 — ISOLAX PEDAL SET (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)

FDA data resources