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510(k) K810971

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

K810971 is an FDA 510(k) premarket notification submitted by Bauer, Cheng & Associates, Inc. for the device "THE GNATOMET". The FDA issued a decision of Substantially Equivalent on May 5, 1981. The device falls under product code EJP (Articulators), a Class I device regulated under 21 CFR 872.3150. Bauer, Cheng & Associates, Inc. has at least 10 other 510(k) clearances on record.

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

FDA data resources