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510(k) K833598

LEBLOND DIAMOND DENTAL BUR by A & M Instruments, Inc. — Product Code EJL

K833598 is an FDA 510(k) premarket notification submitted by A & M Instruments, Inc. for the device "LEBLOND DIAMOND DENTAL BUR". The FDA issued a decision of Substantially Equivalent on December 29, 1983. The device falls under product code EJL (Bur, Dental), a Class I device regulated under 21 CFR 872.3240.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1983
Date Received
October 12, 1983
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 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