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510(k) K833736

GOLD-PALLADIUM-SILVER BASED CAST/ALLOY by Jeneric Ind. — Product Code EIS

K833736 is an FDA 510(k) premarket notification submitted by Jeneric Ind. for the device "GOLD-PALLADIUM-SILVER BASED CAST/ALLOY". The FDA issued a decision of Substantially Equivalent on December 29, 1983. The device falls under product code EIS (Remover, Crown), a Class I device regulated under 21 CFR 872.4565. Jeneric Ind. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1983
Date Received
October 25, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Remover, Crown
Device Class
Class I
Regulation Number
872.4565
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)
  • K840561 — RX ELAN (May 1, 1984)
  • K840563 — RX C & B 20 (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 EIS

  • K992649 — ATD AUTOMATIC BRIDGE REMOVER (October 29, 1999)
  • K951299 — EASY PNEUMATIC CROWN AND BRIDGE REMOVER (August 29, 1995)
  • K863500 — STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR (September 22, 1986)
  • K854795 — HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER (March 4, 1986)
  • K842026 — H-TYPE BRIDGE REMOVER (July 11, 1984)
  • K833290 — C & B 40 PENTRO C & B40 (January 3, 1984)
  • K833287 — SATIN CAST ECONOCAST (January 3, 1984)
  • K833278 — C & B 45 (December 29, 1983)
  • K833289 — C & B 61 PENTRON C & B61 (December 29, 1983)
  • K833280 — SUPRA AP CHOICE 83 (December 26, 1983)

FDA data resources