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510(k) K854691

DIAMOND BURS-HANDPIECE by Almore Intl., Inc. — Product Code EJL

K854691 is an FDA 510(k) premarket notification submitted by Almore Intl., Inc. for the device "DIAMOND BURS-HANDPIECE". The FDA issued a decision of Substantially Equivalent on March 25, 1986. The device falls under product code EJL (Bur, Dental), a Class I device regulated under 21 CFR 872.3240. Almore Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1986
Date Received
November 21, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bur, Dental
Device Class
Class I
Regulation Number
872.3240
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)
  • K854700 — EZ-ON TUBING CONDITIONER (LUBRICANT) (March 12, 1986)
  • K854702 — PLASTIC MOUNTING RINGS (March 6, 1986)
  • K854697 — TUBING HANDPIECE REPLACEMENT (March 6, 1986)
  • K854701 — RETRACT-A-CORD (March 6, 1986)
  • K854699 — TUBING SYRING (January 6, 1986)
  • K831136 — DOUBLE BOW TOOTH SEPARATOR (June 8, 1983)

Other clearances for product code EJL

  • K080687 — SMARTBURS (June 20, 2008)
  • K071352 — CERADRILL (June 29, 2007)
  • K061383 — BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS (August 3, 2006)
  • K943273 — TRI HAWK BUR, FG BUR (August 1, 1994)
  • K926205 — MONOSTERYL (February 10, 1994)
  • K923883 — DENTAL OR SURGICAL BUR (July 27, 1993)
  • K921406 — SILICONT BUR BLOCK (April 28, 1992)
  • K920243 — SMART BURS TOTAL CARBIDES (March 25, 1992)
  • K911208 — TIN COATED DENTAL BURS (September 16, 1991)
  • K910794 — SMALL INSTRUMENT STERILIZATION/BUR BOX (May 23, 1991)

FDA data resources