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510(k) K883074

ELGILOY by Dale T. Dupuis — Product Code EBL

K883074 is an FDA 510(k) premarket notification submitted by Dale T. Dupuis for the device "ELGILOY". The FDA issued a decision of Substantially Equivalent on August 9, 1988. The device falls under product code EBL (Pin, Retentive And Splinting, And Accessory Instruments), a Class I device regulated under 21 CFR 872.3740. Dale T. Dupuis has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1988
Date Received
July 14, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Retentive And Splinting, And Accessory Instruments
Device Class
Class I
Regulation Number
872.3740
Review Panel
DE
Submission Type

Other clearances by Dale T. Dupuis

  • K883388 — DENTREK BRIDGE BARS (October 6, 1988)
  • K882400 — AMORPHUS SILK BY DENTRAX (July 15, 1988)

Other clearances for product code EBL

  • K002693 — CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS) (November 9, 2000)
  • K952868 — DENTAURUM JACKET CROWN & ROOT POSTS (July 19, 1995)
  • K924376 — ROOT CANAL POST (November 22, 1993)
  • K895283 — PROSTHETIC RESTORATION DEVICE (February 14, 1990)
  • K895758 — PLASTIC TOOTH REINFORCEMENT KIT (December 20, 1989)
  • K863831 — VIVADENT FILPIN (October 14, 1986)
  • K844457 — SECURIPIN (December 27, 1984)
  • K830773 — MARKLEY THREADED WIRE (April 28, 1983)
  • K822412 — REINFORCING PIN (August 30, 1982)
  • K760723 — SAFE-T-PINS RETENTIVE PIN SYSTEM (October 21, 1976)

FDA data resources