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510(k) K924376

ROOT CANAL POST by The Thera Group — Product Code EBL

K924376 is an FDA 510(k) premarket notification submitted by The Thera Group for the device "ROOT CANAL POST". The FDA issued a decision of Substantially Equivalent on November 22, 1993. The device falls under product code EBL (Pin, Retentive And Splinting, And Accessory Instruments), a Class I device regulated under 21 CFR 872.3740.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1993
Date Received
August 28, 1992
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 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)
  • K895283 — PROSTHETIC RESTORATION DEVICE (February 14, 1990)
  • K895758 — PLASTIC TOOTH REINFORCEMENT KIT (December 20, 1989)
  • K883074 — ELGILOY (August 9, 1988)
  • 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