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510(k) K863831

VIVADENT FILPIN by Vivadent (Usa), Inc. — Product Code EBL

K863831 is an FDA 510(k) premarket notification submitted by Vivadent (Usa), Inc. for the device "VIVADENT FILPIN". The FDA issued a decision of Substantially Equivalent on October 14, 1986. The device falls under product code EBL (Pin, Retentive And Splinting, And Accessory Instruments), a Class I device regulated under 21 CFR 872.3740. Vivadent (Usa), Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1986
Date Received
September 30, 1986
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 Vivadent (Usa), Inc.

  • K823409 — HELIOSIT-ORTHODONTIC (January 21, 1983)
  • K813015 — HELIOSEAL (December 2, 1981)
  • K802679 — SILANIT (December 17, 1980)
  • K802682 — CONTACT SEAL (November 24, 1980)
  • K802681 — HELIOBOND (November 24, 1980)
  • K802683 — HELIOSIT (November 24, 1980)
  • K802684 — HELIOMAT (November 24, 1980)
  • K802685 — REOLIT (November 12, 1980)
  • K802680 — ISOPAST-DS (November 12, 1980)
  • K801227 — SILICAP (August 12, 1980)

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)
  • K883074 — ELGILOY (August 9, 1988)
  • 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