Home / 510(k) Clearances / K892861

510(k) K892861

DENTAL PIK by U.S. Dentek Corp. — Product Code EKS

K892861 is an FDA 510(k) premarket notification submitted by U.S. Dentek Corp. for the device "DENTAL PIK". The FDA issued a decision of Substantially Equivalent on September 15, 1989. The device falls under product code EKS (File, Pulp Canal, Endodontic), a Class I device regulated under 21 CFR 872.4565. U.S. Dentek Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1989
Date Received
April 18, 1989
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 U.S. Dentek Corp.

  • K961574 — TONGUE SCRAPPER (June 10, 1996)
  • K931360 — ELECTRIC TOOTH-BRUSH (July 13, 1993)
  • K881046 — SUPER PIK MASSAGING PICK FOR ORAL HYGIENE (May 13, 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)
  • K933582 — PROFILE SERIES 29 FILES (October 20, 1993)
  • K902018 — DENTAURUM CERAMIC DEBONDING UNIT (April 3, 1991)

FDA data resources