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510(k) K823913

SOFT GRIP UNI-HANDLE by Treace Medical, Inc. — Product Code EJB

K823913 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "SOFT GRIP UNI-HANDLE". The FDA issued a decision of Substantially Equivalent on January 26, 1983. The device falls under product code EJB (Handle, Instrument, Dental), a Class I device regulated under 21 CFR 872.4565. Treace Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1983
Date Received
December 28, 1982
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 Treace Medical, Inc.

  • K883727 — BUCKET PROSTHESIS PORP (January 13, 1989)
  • K882349 — MALLET, SURGICAL (June 23, 1988)
  • K874779 — BIPOLATOR 50 (January 29, 1988)
  • K873154 — TREACE MAGNUM OTO-TOOL SYSTEM (September 4, 1987)
  • K872000 — EYE GARD (July 21, 1987)
  • K870765 — CANNULATED INSTRUMENT CLEANERS (May 27, 1987)
  • K871706 — OPTHA PREP (May 18, 1987)
  • K870759 — CLEANING SOLUTION, CATALOG NO. 8203 (May 7, 1987)
  • K870766 — PROSTHESIS WIRE (April 15, 1987)
  • K870764 — SCHUKNECHT WIRE CUTTING SCISSORS (March 18, 1987)

Other clearances for product code EJB

  • K140144 — BENDA WEDGE (July 8, 2014)
  • K023367 — DETECTAR, MODEL N123-MI (June 25, 2003)
  • K981234 — FLARE,FILE, FILL (June 5, 1998)
  • K930094 — AUKUSLEEVE (October 20, 1993)
  • K922633 — CAVI-ZYME (August 6, 1992)
  • K871818 — SPATULA, DENTAL, CEMENT (July 2, 1987)
  • K833338 — TOOTH SLOOTH (November 25, 1983)

FDA data resources