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510(k) K920243

SMART BURS TOTAL CARBIDES by Vermont Diamond Instruments — Product Code EJL

K920243 is an FDA 510(k) premarket notification submitted by Vermont Diamond Instruments for the device "SMART BURS TOTAL CARBIDES". The FDA issued a decision of Substantially Equivalent on March 25, 1992. The device falls under product code EJL (Bur, Dental), a Class I device regulated under 21 CFR 872.3240. Vermont Diamond Instruments has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1992
Date Received
January 17, 1992
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 Vermont Diamond Instruments

  • K911111 — MICROMILLS, PATRIOTS, ALPHA GOLD DIAMONDS (November 19, 1991)

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)
  • K911208 — TIN COATED DENTAL BURS (September 16, 1991)
  • K910794 — SMALL INSTRUMENT STERILIZATION/BUR BOX (May 23, 1991)
  • K882183 — DENTAL BURS (June 21, 1988)

FDA data resources