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510(k) K780641

DENTAL ROTARY CARBIDE BURS 76EJL by Teledyne Densco — Product Code EJL

K780641 is an FDA 510(k) premarket notification submitted by Teledyne Densco for the device "DENTAL ROTARY CARBIDE BURS 76EJL". The FDA issued a decision of Substantially Equivalent on April 21, 1978. The device falls under product code EJL (Bur, Dental), a Class I device regulated under 21 CFR 872.3240. Teledyne Densco has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1978
Date Received
April 17, 1978
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 Teledyne Densco

  • K821686 — DENSCO PROPHY ANGLE (June 25, 1982)
  • K821364 — PROFLEX FLEXIBLE SCALER (May 28, 1982)
  • K803155 — PROPHYLAXIS CUP. (January 8, 1981)

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