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510(k) K981234

FLARE,FILE, FILL by Lone Star Technologies — Product Code EJB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1998
Date Received
April 4, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handle, Instrument, Dental
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Lone Star Technologies

  • K980968 — LONE STAR IMPRESSION SYSTEMS (June 9, 1998)

Other clearances for product code EJB

  • K140144 — BENDA WEDGE (July 8, 2014)
  • K023367 — DETECTAR, MODEL N123-MI (June 25, 2003)
  • K930094 — AUKUSLEEVE (October 20, 1993)
  • K922633 — CAVI-ZYME (August 6, 1992)
  • K871818 — SPATULA, DENTAL, CEMENT (July 2, 1987)
  • K833338 — TOOTH SLOOTH (November 25, 1983)
  • K823913 — SOFT GRIP UNI-HANDLE (January 26, 1983)