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510(k) K823685

FILE TYPE H (HEDSTROEM) ENDODONTIC by United Dental Mfg., Inc. — Product Code EKS

K823685 is an FDA 510(k) premarket notification submitted by United Dental Mfg., Inc. for the device "FILE TYPE H (HEDSTROEM) ENDODONTIC". The FDA issued a decision of Substantially Equivalent on December 28, 1982. The device falls under product code EKS (File, Pulp Canal, Endodontic), a Class I device regulated under 21 CFR 872.4565. United Dental Mfg., Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1982
Date Received
December 7, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
File, Pulp Canal, Endodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by United Dental Mfg., Inc.

  • K843017 — ABSORBENT ENDODONTIC POINT (January 9, 1985)
  • K823684 — FILE TYPE K ENDODONTIC (December 28, 1982)
  • K823686 — REAMER TYPE K ENDODONTIC (December 28, 1982)
  • K812886 — ENDODONTIC PAPER POINTS (November 16, 1981)

Other clearances for product code EKS

  • K062856 — TF ROTARY NICKEL TITANIUM FILE (December 13, 2006)
  • K004031 — NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES (March 28, 2001)
  • K971319 — NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES (May 22, 1997)
  • K970649 — HERO 642 (May 16, 1997)
  • K962031 — QUANTEC SERIES 2000 ENDODONTIC FILES (June 4, 1996)
  • K953604 — SHAPING HEDSTROM N.T. (September 28, 1995)
  • K935542 — NICKEL-TITANIUM K-TYPE FILE (January 3, 1994)
  • K932529 — LIGHTSPEED DENTAL HAND INSTRUMENT (November 4, 1993)
  • K933582 — PROFILE SERIES 29 FILES (October 20, 1993)
  • K902018 — DENTAURUM CERAMIC DEBONDING UNIT (April 3, 1991)

FDA data resources