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510(k) K833049

PALLADENT by Jeneric Ind. — Product Code EJS

K833049 is an FDA 510(k) premarket notification submitted by Jeneric Ind. for the device "PALLADENT". The FDA issued a decision of Substantially Equivalent on October 28, 1983. The device falls under product code EJS (Alloy, Other Noble Metal), a Class II device regulated under 21 CFR 872.3060. Jeneric Ind. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1983
Date Received
September 7, 1983
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 Jeneric Ind.

  • K862822 — REXILLIUM N. B. F. (September 2, 1986)
  • K862926 — SURGICAL VITEX (August 29, 1986)
  • K854878 — H40 BASE METAL ALLOY (January 30, 1986)
  • K844123 — RX CBY (January 9, 1985)
  • K844122 — RX CBG (January 9, 1985)
  • K840563 — RX C & B 20 (May 1, 1984)
  • K840561 — RX ELAN (May 1, 1984)
  • K840562 — REX V (April 13, 1984)
  • K834560 — VITEX P.D.A (February 27, 1984)
  • K833774 — NATURELLE II & LITE II-N72-N74-L (January 24, 1984)

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