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510(k) K892893

SDI POLYCARBONATE CROWN, SCHEIN'S by Svenska Dental Instruments AB — Product Code ELZ

K892893 is an FDA 510(k) premarket notification submitted by Svenska Dental Instruments AB for the device "SDI POLYCARBONATE CROWN, SCHEIN'S". The FDA issued a decision of Substantially Equivalent on June 6, 1989. The device falls under product code ELZ (Crown, Preformed), a Class I device regulated under 21 CFR 872.3330. Svenska Dental Instruments AB has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1989
Date Received
April 20, 1989
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 Svenska Dental Instruments AB

  • K022265 — LIGHT TIP (October 2, 2002)
  • K022264 — CLEAN 'N' OIL (October 2, 2002)
  • K892894 — S-FILE, S-FINDER, S-ENGINE FILE (May 24, 1989)

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)
  • 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