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510(k) K801886

BURR, DENTAL by Aesculap Instruments Corp. — Product Code EJL

K801886 is an FDA 510(k) premarket notification submitted by Aesculap Instruments Corp. for the device "BURR, DENTAL". The FDA issued a decision of Substantially Equivalent on August 20, 1980. The device falls under product code EJL (Bur, Dental), a Class I device regulated under 21 CFR 872.3240. Aesculap Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1980
Date Received
July 28, 1980
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 Aesculap Instruments Corp.

  • K890182 — PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV (February 28, 1990)
  • K885046 — INSITUCAT VALVE STRIPPER (February 28, 1990)
  • K890443 — CASPAR SCALP CLIP, APPLIER (June 15, 1989)
  • K893121 — ROBOTRAC (TM) RETRACTOR ARM (June 1, 1989)
  • K884057 — ELAN-E DISPOSABLE DRAPE (October 19, 1988)
  • K880704 — CERULLO SUCTION REGULATOR (March 29, 1988)
  • K860016 — AESCULAP BONE MILL (March 19, 1986)
  • K801888 — HANDPIECE, DENTAL (August 20, 1980)
  • K801887 — DRILL, DENTAL (August 20, 1980)
  • K792558 — CONTAINER SYSTEM (December 27, 1979)

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