Home / 510(k) Clearances / K962031

510(k) K962031

QUANTEC SERIES 2000 ENDODONTIC FILES by Tycom Dental — Product Code EKS

K962031 is an FDA 510(k) premarket notification submitted by Tycom Dental for the device "QUANTEC SERIES 2000 ENDODONTIC FILES". The FDA issued a decision of Substantially Equivalent on June 4, 1996. The device falls under product code EKS (File, Pulp Canal, Endodontic), a Class I device regulated under 21 CFR 872.4565. Tycom Dental has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1996
Date Received
May 24, 1996
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 Tycom Dental

  • K971319 — NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES (May 22, 1997)

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)
  • 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)
  • K905461 — PROCEDURE KIT/ROUTINE DENTAL PROCEDURES (March 5, 1991)

FDA data resources