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510(k) K895958

BREVET FLOSS PICK (AUTOCLAVE STERILIZER) by Brevet, Inc. — Product Code EKJ

K895958 is an FDA 510(k) premarket notification submitted by Brevet, Inc. for the device "BREVET FLOSS PICK (AUTOCLAVE STERILIZER)". The FDA issued a decision of Substantially Equivalent on December 4, 1989. The device falls under product code EKJ (Burnisher, Operative), a Class I device regulated under 21 CFR 872.4565. Brevet, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1989
Date Received
October 11, 1989
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 Brevet, Inc.

  • K910794 — SMALL INSTRUMENT STERILIZATION/BUR BOX (May 23, 1991)
  • K895959 — BREVET FLOSS PICK (COLD STERILIZATION FLUIDS) (November 29, 1989)
  • K895753 — BREVET DISPOSABLE CONNECTORS (November 14, 1989)
  • K883126 — BREVET DENTAL INSTRUMENTS (October 5, 1988)
  • K882617 — BREVET CASSETTE STERILIZATION MODULE (July 28, 1988)

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