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510(k) K892373

DENTAL PLASTIC BITE FORK by Texapol Corp. — Product Code EJP

K892373 is an FDA 510(k) premarket notification submitted by Texapol Corp. for the device "DENTAL PLASTIC BITE FORK". The FDA issued a decision of Substantially Equivalent on June 12, 1989. The device falls under product code EJP (Articulators), a Class I device regulated under 21 CFR 872.3150.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1989
Date Received
April 6, 1989
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 for product code EJP

  • K926190 — ALRAND INC. (DENTAL HAND INSTRUMENTS) (January 18, 1994)
  • K896131 — GNATHOMAT ARTICULATOR (December 4, 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)
  • K811075 — BALANCE ARTICULATOR (May 13, 1981)
  • K810971 — THE GNATOMET (May 5, 1981)
  • K801342 — DISPOSABLE ARTICULATOR (July 8, 1980)

FDA data resources