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510(k) K071352

CERADRILL by Gebr. Brasseler GmbH & Co. KG — Product Code EJL

K071352 is an FDA 510(k) premarket notification submitted by Gebr. Brasseler GmbH & Co. KG for the device "CERADRILL". The FDA issued a decision of Substantially Equivalent on June 29, 2007. The device falls under product code EJL (Bur, Dental), a Class I device regulated under 21 CFR 872.3240. Gebr. Brasseler GmbH & Co. KG has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2007
Date Received
May 15, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Bur, Dental
Device Class
Class I
Regulation Number
872.3240
Review Panel
DE
Submission Type

Other clearances by Gebr. Brasseler GmbH & Co. KG

  • K131264 — KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS (July 26, 2013)

Other clearances for product code EJL

  • K080687 — SMARTBURS (June 20, 2008)
  • 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)
  • K882183 — DENTAL BURS (June 21, 1988)

FDA data resources