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510(k) K912686

WHITER BITER CROWN by George M. Wilson, Dds — Product Code ELZ

K912686 is an FDA 510(k) premarket notification submitted by George M. Wilson, Dds for the device "WHITER BITER CROWN". The FDA issued a decision of Substantially Equivalent on September 16, 1991. The device falls under product code ELZ (Crown, Preformed), a Class I device regulated under 21 CFR 872.3330. George M. Wilson, Dds has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1991
Date Received
June 18, 1991
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 George M. Wilson, Dds

  • K931352 — PEDO JACKETS OR PJ'S (July 21, 1993)
  • K913152 — WHITER BITER CROWN (September 30, 1991)

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)
  • 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