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510(k) K810972

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

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.

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  • 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)
  • K810971 — THE GNATOMET (May 5, 1981)
  • K810969 — ISOSIT C & B MATERIAL (May 5, 1981)

Other clearances for product code KZO

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