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510(k) K923883

DENTAL OR SURGICAL BUR by Stratum Dental Technologies, Inc. — Product Code EJL

K923883 is an FDA 510(k) premarket notification submitted by Stratum Dental Technologies, Inc. for the device "DENTAL OR SURGICAL BUR". The FDA issued a decision of Substantially Equivalent on July 27, 1993. 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
July 27, 1993
Date Received
August 4, 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 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)
  • 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)
  • K882183 — DENTAL BURS (June 21, 1988)

FDA data resources