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510(k) K012060

MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT by Hu-Friedy Mfg. Co., Inc. — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2001
Date Received
July 2, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scaler, Ultrasonic
Device Class
Class II
Regulation Number
872.4850
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)
  • K953919 — DENTAL ULTRASONIC SCALER INSERTS (October 7, 1995)
  • K912473 — ACCU-PLACER TM KIT (July 24, 1991)
  • K844002 — HU-FRIEDY IMS CASSETTE SYSTEM (November 8, 1984)

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