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510(k) K810969

ISOSIT C & B MATERIAL by Bauer, Cheng & Associates, Inc. — Product Code EBF

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
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

Other clearances by Bauer, Cheng & Associates, Inc.

  • K840084 — COLTENE BRILLIANT LUX (March 30, 1984)
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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)
  • K810972 — THE GNATHOMETER-M (May 5, 1981)

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