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510(k) K823099

RX MIDACAST by Bauer, Cheng & Associates, Inc. — Product Code EJT

K823099 is an FDA 510(k) premarket notification submitted by Bauer, Cheng & Associates, Inc. for the device "RX MIDACAST". The FDA issued a decision of Substantially Equivalent on November 10, 1982. The device falls under product code EJT (Alloy, Gold-Based 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, Gold-Based 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)
  • K823097 — NATURELLE (November 10, 1982)
  • K823084 — CHALLENGER (November 10, 1982)
  • K823098 — REX-CAPS (November 10, 1982)
  • K823100 — RX 91 (November 10, 1982)
  • K810969 — ISOSIT C & B MATERIAL (May 5, 1981)
  • K810970 — ISOSIT TEETH (May 5, 1981)
  • K810972 — THE GNATHOMETER-M (May 5, 1981)
  • K810971 — THE GNATOMET (May 5, 1981)

Other clearances for product code EJT

  • K052463 — PROMETAL HN86 (October 14, 2005)
  • K041378 — BIO 60 (August 2, 2004)
  • K040672 — PORTA REFLEX (May 27, 2004)
  • K040524 — PORTA SOLDER 1090 W (May 20, 2004)
  • K040043 — NDX-40 ALLOY (March 3, 2004)
  • K034049 — HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, (March 1, 2004)
  • K033279 — GOLD DENTAL CASTING ALLOYS (January 15, 2004)
  • K033446 — APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 (November 13, 2003)
  • K033435 — E-SARANG 86, DM78, DM55 (November 12, 2003)
  • K032320 — APPOLLO 3 ALLOY (October 1, 2003)

FDA data resources