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510(k) K883325

PERFORMED CROWN (STAINLESS STEEL) by Whitecap Dental Co. — Product Code ELZ

K883325 is an FDA 510(k) premarket notification submitted by Whitecap Dental Co. for the device "PERFORMED CROWN (STAINLESS STEEL)". The FDA issued a decision of Substantially Equivalent on September 16, 1988. The device falls under product code ELZ (Crown, Preformed), a Class I device regulated under 21 CFR 872.3330.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1988
Date Received
August 5, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crown, Preformed
Device Class
Class I
Regulation Number
872.3330
Review Panel
DE
Submission Type

Other clearances for product code ELZ

  • K091362 — CERAMIC PEDATRIC PREFORMED CROWN (June 29, 2009)
  • K932759 — TEMPOARY POLYCARBONATE CROWNS (July 22, 1994)
  • K931352 — PEDO JACKETS OR PJ'S (July 21, 1993)
  • K913152 — WHITER BITER CROWN (September 30, 1991)
  • K912686 — WHITER BITER CROWN (September 16, 1991)
  • K892893 — SDI POLYCARBONATE CROWN, SCHEIN'S (June 6, 1989)
  • K771128 — NEKO CERAMIC CONVENIENCE CROWNS (July 15, 1977)
  • K770684 — CROWN, ACRYLIC, CORAL BRAND, PREFORMED (April 26, 1977)

FDA data resources