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510(k) K811075

BALANCE ARTICULATOR by Almore Intl., Inc. — Product Code EJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1981
Date Received
April 20, 1981
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 Almore Intl., Inc.

  • K862851 — ALMORE FACE MASK (August 12, 1986)
  • K854692 — MONARCH II BLEACHING INSTRUMENT (May 12, 1986)
  • K854696 — OP II VISIBLE LIGHT CURING SYSTEM (March 26, 1986)
  • K854690 — DIAMONDS BURS-COMPOSIT FINISHING (March 25, 1986)
  • K854691 — DIAMOND BURS-HANDPIECE (March 25, 1986)
  • K854700 — EZ-ON TUBING CONDITIONER (LUBRICANT) (March 12, 1986)
  • K854702 — PLASTIC MOUNTING RINGS (March 6, 1986)
  • K854701 — RETRACT-A-CORD (March 6, 1986)
  • K854697 — TUBING HANDPIECE REPLACEMENT (March 6, 1986)
  • K854699 — TUBING SYRING (January 6, 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)
  • 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)
  • K810971 — THE GNATOMET (May 5, 1981)
  • K801342 — DISPOSABLE ARTICULATOR (July 8, 1980)