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510(k) K823100

RX 91 by Bauer, Cheng & Associates, Inc. — Product Code EJS

K823100 is an FDA 510(k) premarket notification submitted by Bauer, Cheng & Associates, Inc. for the device "RX 91". The FDA issued a decision of Substantially Equivalent on November 10, 1982. The device falls under product code EJS (Alloy, Other Noble Metal), a Class II device regulated under 21 CFR 872.3060. Bauer, Cheng & Associates, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1982
Date Received
October 19, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Other Noble Metal
Device Class
Class II
Regulation Number
872.3060
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)
  • K823084 — CHALLENGER (November 10, 1982)
  • K823098 — REX-CAPS (November 10, 1982)
  • K823099 — RX MIDACAST (November 10, 1982)
  • K823097 — NATURELLE (November 10, 1982)
  • K810972 — THE GNATHOMETER-M (May 5, 1981)
  • 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 EJS

  • K041433 — BRIGHT GOLD XH (August 19, 2004)
  • K040436 — SIMIDUR SUPERIOR (March 5, 2004)
  • K022252 — STERNGOLD 1, MODEL 1127781 (September 19, 2002)
  • K022469 — ECO E4 (September 18, 2002)
  • K021367 — STERNGOLD 66, MODEL #1180230 (May 16, 2002)
  • K020195 — SIMIDUR S1S (March 15, 2002)
  • K020192 — SIMIDUR S2 (March 15, 2002)
  • K020194 — SIMIDUR KF PLUS (March 15, 2002)
  • K014042 — D.SIGN 84 (February 22, 2002)
  • K013809 — D.SIGN 59 (February 7, 2002)

FDA data resources