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510(k) K884418

PREMIER DIE-TRAK ARTICULATOR by Premier Medical — Product Code EJP

K884418 is an FDA 510(k) premarket notification submitted by Premier Medical for the device "PREMIER DIE-TRAK ARTICULATOR". The FDA issued a decision of Substantially Equivalent on November 14, 1988. The device falls under product code EJP (Articulators), a Class I device regulated under 21 CFR 872.3150. Premier Medical has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1988
Date Received
October 20, 1988
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 Premier Medical

  • K896303 — BIOPSY PUNCH (February 13, 1990)
  • K894050 — MODIFIED DECANNULATION STOPPER (August 1, 1989)

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)
  • K872943 — DISPOSABLE ARTICULATOR (August 11, 1987)
  • K863009 — GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX (September 25, 1986)
  • 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