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510(k) K882183

DENTAL BURS by Tri-Stage, Inc. — Product Code EJL

K882183 is an FDA 510(k) premarket notification submitted by Tri-Stage, Inc. for the device "DENTAL BURS". The FDA issued a decision of Substantially Equivalent on June 21, 1988. The device falls under product code EJL (Bur, Dental), a Class I device regulated under 21 CFR 872.3240. Tri-Stage, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1988
Date Received
May 24, 1988
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 Tri-Stage, Inc.

  • K882834 — TISSUE PUNCH (August 2, 1988)
  • K880220 — TRI-STAGE (TS-I) DENTAL IMPLANT (March 31, 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)
  • K910794 — SMALL INSTRUMENT STERILIZATION/BUR BOX (May 23, 1991)

FDA data resources