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510(k) K770684

CROWN, ACRYLIC, CORAL BRAND, PREFORMED by Parker Laboratories, Inc. — Product Code ELZ

K770684 is an FDA 510(k) premarket notification submitted by Parker Laboratories, Inc. for the device "CROWN, ACRYLIC, CORAL BRAND, PREFORMED". The FDA issued a decision of Substantially Equivalent on April 26, 1977. The device falls under product code ELZ (Crown, Preformed), a Class I device regulated under 21 CFR 872.3330. Parker Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1977
Date Received
April 12, 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 Parker Laboratories, Inc.

  • K233965 — UltraDrape UGPIV Barrier and Securement (34-15) (August 15, 2024)
  • K953673 — ECLIPSE PROBE COVER (March 14, 1996)
  • K921695 — ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS (February 23, 1995)
  • K864556 — AQUALUBE(TM) (December 1, 1986)
  • K861239 — ACRYLIC SOLDER (April 17, 1986)
  • K855167 — DYNA SYSTEM (March 4, 1986)
  • K851895 — POLYGEL ULTRASOUND GEL (September 27, 1985)
  • K852956 — CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION (August 9, 1985)
  • K841400 — NEURO PULSE (June 15, 1984)
  • K840548 — RESIL (April 17, 1984)

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)
  • K771128 — NEKO CERAMIC CONVENIENCE CROWNS (July 15, 1977)

FDA data resources