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510(k) K810972

THE GNATHOMETER-M by Bauer, Cheng & Associates, Inc. — Product Code KZO

K810972 is an FDA 510(k) premarket notification submitted by Bauer, Cheng & Associates, Inc. for the device "THE GNATHOMETER-M". The FDA issued a decision of Substantially Equivalent on May 5, 1981. The device falls under product code KZO (Ink, Arch Tracing), 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
Ink, Arch Tracing
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)
  • K810971 — THE GNATOMET (May 5, 1981)
  • K810969 — ISOSIT C & B MATERIAL (May 5, 1981)
  • K810970 — ISOSIT TEETH (May 5, 1981)

Other clearances for product code KZO

  • K771176 — GOTHIC ARCH TRACING (August 16, 1977)

FDA data resources