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510(k) K771128

NEKO CERAMIC CONVENIENCE CROWNS by Sterndent Corp. — Product Code ELZ

K771128 is an FDA 510(k) premarket notification submitted by Sterndent Corp. for the device "NEKO CERAMIC CONVENIENCE CROWNS". The FDA issued a decision of Substantially Equivalent on July 15, 1977. The device falls under product code ELZ (Crown, Preformed), a Class I device regulated under 21 CFR 872.3330. Sterndent Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1977
Date Received
June 23, 1977
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 by Sterndent Corp.

  • K770667 — CHROMASCAN TM (April 20, 1977)

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)
  • K883325 — PERFORMED CROWN (STAINLESS STEEL) (September 16, 1988)
  • K770684 — CROWN, ACRYLIC, CORAL BRAND, PREFORMED (April 26, 1977)

FDA data resources