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510(k) K921406

SILICONT BUR BLOCK by Innovators, Inc. — Product Code EJL

K921406 is an FDA 510(k) premarket notification submitted by Innovators, Inc. for the device "SILICONT BUR BLOCK". The FDA issued a decision of Substantially Equivalent on April 28, 1992. The device falls under product code EJL (Bur, Dental), a Class I device regulated under 21 CFR 872.3240. Innovators, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1992
Date Received
March 20, 1992
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 Innovators, Inc.

  • K921355 — WINGMASTER (September 25, 1992)
  • K921354 — BLUNT TIP IRRIGATION NEEDLES (September 25, 1992)
  • K844351 — OPTI-LITE (December 21, 1984)
  • K830042 — E-Z JECTOR (January 26, 1983)
  • K790984 — KLIP-LITE (October 22, 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)
  • 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