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510(k) K912473

ACCU-PLACER TM KIT by Hu-Friedy Mfg. Co., Inc. — Product Code EKJ

K912473 is an FDA 510(k) premarket notification submitted by Hu-Friedy Mfg. Co., Inc. for the device "ACCU-PLACER TM KIT". The FDA issued a decision of Substantially Equivalent on July 24, 1991. The device falls under product code EKJ (Burnisher, Operative), a Class I device regulated under 21 CFR 872.4565. Hu-Friedy Mfg. Co., Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1991
Date Received
June 4, 1991
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 Hu-Friedy Mfg. Co., Inc.

  • K120659 — HU-FRIEDY DENTAL CARTRIDGE SYRINGE (November 6, 2012)
  • K100401 — SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM (March 30, 2010)
  • K073369 — EI DOWNPAK BARRIER SLEEVES (February 27, 2008)
  • K070975 — SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES (June 21, 2007)
  • K053178 — SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS (February 1, 2006)
  • K012060 — MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT (July 27, 2001)
  • K953919 — DENTAL ULTRASONIC SCALER INSERTS (October 7, 1995)
  • K844002 — HU-FRIEDY IMS CASSETTE SYSTEM (November 8, 1984)

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