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510(k) K830773

MARKLEY THREADED WIRE by Almore Intl., Inc. — Product Code EBL

K830773 is an FDA 510(k) premarket notification submitted by Almore Intl., Inc. for the device "MARKLEY THREADED WIRE". The FDA issued a decision of Substantially Equivalent on April 28, 1983. The device falls under product code EBL (Pin, Retentive And Splinting, And Accessory Instruments), a Class I device regulated under 21 CFR 872.3740. Almore Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1983
Date Received
March 11, 1983
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 Almore Intl., Inc.

  • K862851 — ALMORE FACE MASK (August 12, 1986)
  • K854692 — MONARCH II BLEACHING INSTRUMENT (May 12, 1986)
  • K854696 — OP II VISIBLE LIGHT CURING SYSTEM (March 26, 1986)
  • K854690 — DIAMONDS BURS-COMPOSIT FINISHING (March 25, 1986)
  • K854691 — DIAMOND BURS-HANDPIECE (March 25, 1986)
  • K854700 — EZ-ON TUBING CONDITIONER (LUBRICANT) (March 12, 1986)
  • K854701 — RETRACT-A-CORD (March 6, 1986)
  • K854702 — PLASTIC MOUNTING RINGS (March 6, 1986)
  • K854697 — TUBING HANDPIECE REPLACEMENT (March 6, 1986)
  • K854699 — TUBING SYRING (January 6, 1986)

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)
  • K863831 — VIVADENT FILPIN (October 14, 1986)
  • K844457 — SECURIPIN (December 27, 1984)
  • K822412 — REINFORCING PIN (August 30, 1982)
  • K760723 — SAFE-T-PINS RETENTIVE PIN SYSTEM (October 21, 1976)

FDA data resources