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510(k) K771347

R&R ALSTON CARBIDE BURS by Ransom and Randolph — Product Code EJL

K771347 is an FDA 510(k) premarket notification submitted by Ransom and Randolph for the device "R&R ALSTON CARBIDE BURS". The FDA issued a decision of Substantially Equivalent on August 3, 1977. The device falls under product code EJL (Bur, Dental), a Class I device regulated under 21 CFR 872.3240. Ransom and Randolph has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1977
Date Received
July 20, 1977
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 Ransom and Randolph

  • K781605 — R&R ABSORBENT POINTS (October 10, 1978)
  • K780399 — INSTRUMENT CLEANING BRUSH (March 17, 1978)
  • K780198 — PROPHY CUPS, R&R (February 16, 1978)
  • K780199 — PROPHY ANGLES, R&R (February 16, 1978)
  • K770598 — ENDODONTIC INSTRUMENTS, R&R CUTWELL (April 5, 1977)
  • K761067 — DENTSPLY DIE STONE (November 30, 1976)

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