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510(k) K910794

SMALL INSTRUMENT STERILIZATION/BUR BOX by Brevet, Inc. — Product Code EJL

K910794 is an FDA 510(k) premarket notification submitted by Brevet, Inc. for the device "SMALL INSTRUMENT STERILIZATION/BUR BOX". The FDA issued a decision of Substantially Equivalent on May 23, 1991. The device falls under product code EJL (Bur, Dental), a Class I device regulated under 21 CFR 872.3240. Brevet, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1991
Date Received
February 25, 1991
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 Brevet, Inc.

  • K895958 — BREVET FLOSS PICK (AUTOCLAVE STERILIZER) (December 4, 1989)
  • K895959 — BREVET FLOSS PICK (COLD STERILIZATION FLUIDS) (November 29, 1989)
  • K895753 — BREVET DISPOSABLE CONNECTORS (November 14, 1989)
  • K883126 — BREVET DENTAL INSTRUMENTS (October 5, 1988)
  • K882617 — BREVET CASSETTE STERILIZATION MODULE (July 28, 1988)

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)
  • K882183 — DENTAL BURS (June 21, 1988)

FDA data resources