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510(k) K770093

DENTAL BURS by The S. S. White Co. — Product Code EJL

K770093 is an FDA 510(k) premarket notification submitted by The S. S. White Co. for the device "DENTAL BURS". The FDA issued a decision of Substantially Equivalent on January 24, 1977. The device falls under product code EJL (Bur, Dental), a Class I device regulated under 21 CFR 872.3240. The S. S. White Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1977
Date Received
January 17, 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 The S. S. White Co.

  • K852745 — PORCELAIN VENEER SYSTEM BONDING KIT (August 16, 1985)
  • K852744 — CHARACTERIZER KIT VISIBLE LIGHT CURED RESTOR-COLOR (August 16, 1985)
  • K853005 — S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM (August 13, 1985)
  • K852743 — PORCELAIN VENEER SYSTEM LABORATORY KIT (July 31, 1985)
  • K852182 — EASY TRAY & EASY BASE CUSTOM IMPRESSION TRAY MATER (July 2, 1985)
  • K837440 — UNKNOWN (June 10, 1983)
  • K827816 — PODIATRY X-RAY UNIT (August 24, 1982)
  • K781293 — RESTORATIVE SYSTEM PROFILE (August 18, 1978)
  • K771938 — ALGINATE IMPRESSION MATERIAL (November 2, 1977)
  • K760369 — POWDERLITE (August 11, 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