Home / 510(k) Clearances / K933582

510(k) K933582

PROFILE SERIES 29 FILES by Tulsa Dental Products, Ltd. — Product Code EKS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1993
Date Received
July 23, 1993
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 Tulsa Dental Products, Ltd.

  • K970134 — THERMAPREP PLUS OVEN (March 21, 1997)
  • K964174 — MINERAL TRIOXIDE AGGREGATE (MTA) (February 10, 1997)
  • K954790 — PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS (January 16, 1996)
  • K922931 — THERMAPOST ENDODONTIC ROOT CANAL POST (May 26, 1994)
  • K910224 — THERMAPREP (March 29, 1991)
  • K900986 — THERMAFIL ENDODONTIC OBTURATOR (November 13, 1990)
  • K881139 — THERMAFIL ENDODONTIC OBTURATOR (April 7, 1988)

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)
  • K902018 — DENTAURUM CERAMIC DEBONDING UNIT (April 3, 1991)
  • K905461 — PROCEDURE KIT/ROUTINE DENTAL PROCEDURES (March 5, 1991)