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510(k) K822412

REINFORCING PIN by Filhol — Product Code EBL

K822412 is an FDA 510(k) premarket notification submitted by Filhol for the device "REINFORCING PIN". The FDA issued a decision of Substantially Equivalent on August 30, 1982. 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
August 30, 1982
Date Received
August 10, 1982
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

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  • 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)
  • K883074 — ELGILOY (August 9, 1988)
  • K863831 — VIVADENT FILPIN (October 14, 1986)
  • K844457 — SECURIPIN (December 27, 1984)
  • K830773 — MARKLEY THREADED WIRE (April 28, 1983)
  • K760723 — SAFE-T-PINS RETENTIVE PIN SYSTEM (October 21, 1976)

FDA data resources