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510(k) K854795

HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER by Fran Hazelton Co. — Product Code EIS

K854795 is an FDA 510(k) premarket notification submitted by Fran Hazelton Co. for the device "HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER". The FDA issued a decision of Substantially Equivalent on March 4, 1986. The device falls under product code EIS (Remover, Crown), a Class I device regulated under 21 CFR 872.4565.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1986
Date Received
December 2, 1985
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 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)
  • K842026 — H-TYPE BRIDGE REMOVER (July 11, 1984)
  • K833287 — SATIN CAST ECONOCAST (January 3, 1984)
  • K833290 — C & B 40 PENTRO C & B40 (January 3, 1984)
  • K833289 — C & B 61 PENTRON C & B61 (December 29, 1983)
  • K833736 — GOLD-PALLADIUM-SILVER BASED CAST/ALLOY (December 29, 1983)
  • K833278 — C & B 45 (December 29, 1983)
  • K833280 — SUPRA AP CHOICE 83 (December 26, 1983)

FDA data resources