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510(k) K061383

BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS by B.T.I. Biotechnology Institute, Sl. — Product Code EJL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2006
Date Received
May 18, 2006
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

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Other clearances for product code EJL

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  • 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)