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510(k) K073369

EI DOWNPAK BARRIER SLEEVES by Hu-Friedy Mfg. Co., Inc. — Product Code EKM

K073369 is an FDA 510(k) premarket notification submitted by Hu-Friedy Mfg. Co., Inc. for the device "EI DOWNPAK BARRIER SLEEVES". The FDA issued a decision of Substantially Equivalent on February 27, 2008. The device falls under product code EKM (Gutta-Percha), a Class I device regulated under 21 CFR 872.3850. Hu-Friedy Mfg. Co., Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2008
Date Received
November 30, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gutta-Percha
Device Class
Class I
Regulation Number
872.3850
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)
  • 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)
  • K912473 — ACCU-PLACER TM KIT (July 24, 1991)
  • K844002 — HU-FRIEDY IMS CASSETTE SYSTEM (November 8, 1984)

Other clearances for product code EKM

  • K070246 — DOWN PAK (February 16, 2007)
  • K051573 — TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) (June 26, 2006)
  • K042870 — ENDO TWINN (January 11, 2005)
  • K023819 — FIBERFILL SGP (March 26, 2003)
  • K971641 — ANTIBACTERIAL GUTTA PERCHA (July 21, 1997)
  • K970134 — THERMAPREP PLUS OVEN (March 21, 1997)
  • K931742 — INJECT-R FILL (May 27, 1993)
  • K924825 — MICRODOSE RC-EZ (March 5, 1993)
  • K915243 — TOUCH 'N HEAT MODEL 5002, MODIFICATION (January 21, 1992)
  • K910224 — THERMAPREP (March 29, 1991)

FDA data resources