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510(k) K810971

THE GNATOMET by Bauer, Cheng & Associates, Inc. — Product Code EJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1981
Date Received
April 9, 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 Bauer, Cheng & Associates, Inc.

  • K840084 — COLTENE BRILLIANT LUX (March 30, 1984)
  • K840085 — COLTENE BRILLIANT (March 16, 1984)
  • K823098 — REX-CAPS (November 10, 1982)
  • K823084 — CHALLENGER (November 10, 1982)
  • K823099 — RX MIDACAST (November 10, 1982)
  • K823100 — RX 91 (November 10, 1982)
  • K823097 — NATURELLE (November 10, 1982)
  • K810970 — ISOSIT TEETH (May 5, 1981)
  • K810972 — THE GNATHOMETER-M (May 5, 1981)
  • K810969 — ISOSIT C & B MATERIAL (May 5, 1981)

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)
  • K811075 — BALANCE ARTICULATOR (May 13, 1981)
  • K801342 — DISPOSABLE ARTICULATOR (July 8, 1980)