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510(k) K932759

TEMPOARY POLYCARBONATE CROWNS by South American Dental Exporting Corp. — Product Code ELZ

K932759 is an FDA 510(k) premarket notification submitted by South American Dental Exporting Corp. for the device "TEMPOARY POLYCARBONATE CROWNS". The FDA issued a decision of Substantially Equivalent on July 22, 1994. 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
July 22, 1994
Date Received
June 8, 1993
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)
  • 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)
  • K883325 — PERFORMED CROWN (STAINLESS STEEL) (September 16, 1988)
  • K771128 — NEKO CERAMIC CONVENIENCE CROWNS (July 15, 1977)
  • K770684 — CROWN, ACRYLIC, CORAL BRAND, PREFORMED (April 26, 1977)

FDA data resources