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510(k) K905461

PROCEDURE KIT/ROUTINE DENTAL PROCEDURES by Angiosystems, Inc. — Product Code EKS

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
March 5, 1991
Date Received
December 5, 1990
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 Angiosystems, Inc.

  • K905464 — MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING (May 31, 1991)
  • K905459 — SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM (April 5, 1991)
  • K905466 — STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE (February 11, 1991)
  • K905465 — STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPE (February 11, 1991)
  • K905460 — STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY (February 6, 1991)
  • K905462 — PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES (February 6, 1991)
  • K905463 — GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION (January 22, 1991)
  • K864688 — ARNOLD-KING PRESSURE DRESSING (January 12, 1987)
  • K843259 — ANGIO SYS FLUOROSCOPE DRAPE (September 21, 1984)
  • K843258 — ANGIO SYS BRACHIAL ANGIO DRAPE (September 21, 1984)

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)