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510(k) K921354

BLUNT TIP IRRIGATION NEEDLES by Innovators, Inc. — Product Code EKJ

K921354 is an FDA 510(k) premarket notification submitted by Innovators, Inc. for the device "BLUNT TIP IRRIGATION NEEDLES". The FDA issued a decision of Substantially Equivalent on September 25, 1992. The device falls under product code EKJ (Burnisher, Operative), a Class I device regulated under 21 CFR 872.4565. Innovators, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1992
Date Received
March 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Burnisher, Operative
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Innovators, Inc.

  • K921355 — WINGMASTER (September 25, 1992)
  • K921406 — SILICONT BUR BLOCK (April 28, 1992)
  • K844351 — OPTI-LITE (December 21, 1984)
  • K830042 — E-Z JECTOR (January 26, 1983)
  • K790984 — KLIP-LITE (October 22, 1979)

Other clearances for product code EKJ

  • K961714 — ASEPTYLUM, UNI-CARRIER (June 10, 1996)
  • K953707 — MEDTROL DENTAL KIT (January 4, 1996)
  • K945815 — DENTAL KIT (July 19, 1995)
  • K951607 — SUREFLEX FILES (June 22, 1995)
  • K945077 — INSTRUMENT,FILLING,PLASTIC,DENTAL (November 30, 1994)
  • K943820 — STAT PAK (November 2, 1994)
  • K943351 — MAUNAL DISPOSABLE DENTAL INSTRUMENTS (October 7, 1994)
  • K943584 — PRESTERILIZED ENDODONTIC FILES (September 21, 1994)
  • K935127 — SOUTHLAND STERILE DENTAL SYSTEM (July 28, 1994)
  • K941954 — NON-FOGGING DENTAL MIRROR (July 8, 1994)

FDA data resources