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510(k) K833285

RX IV PENTRON IV by Genesis Industries, Inc. — Product Code EIS

K833285 is an FDA 510(k) premarket notification submitted by Genesis Industries, Inc. for the device "RX IV PENTRON IV". The FDA issued a decision of Substantially Equivalent on December 22, 1983. The device falls under product code EIS (Remover, Crown), a Class I device regulated under 21 CFR 872.4565. Genesis Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1983
Date Received
September 22, 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 Genesis Industries, Inc.

  • K994361 — ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO (February 18, 2000)
  • K962828 — EVERT-IT (February 10, 1997)
  • K880377 — NOVO VIVO MODEL #17140 AND #17135 (April 4, 1988)
  • K880376 — NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP (February 16, 1988)
  • K833287 — SATIN CAST ECONOCAST (January 3, 1984)
  • K833290 — C & B 40 PENTRO C & B40 (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)
  • K833288 — C & B57 PENTRON C & B57 (December 20, 1983)

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)
  • K833736 — GOLD-PALLADIUM-SILVER BASED CAST/ALLOY (December 29, 1983)
  • K833289 — C & B 61 PENTRON C & B61 (December 29, 1983)
  • K833278 — C & B 45 (December 29, 1983)

FDA data resources