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510(k) K070246

DOWN PAK by Endo Twinn B.V. — Product Code EKM

K070246 is an FDA 510(k) premarket notification submitted by Endo Twinn B.V. for the device "DOWN PAK". The FDA issued a decision of Substantially Equivalent on February 16, 2007. The device falls under product code EKM (Gutta-Percha), a Class I device regulated under 21 CFR 872.3850. Endo Twinn B.V. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2007
Date Received
January 25, 2007
Clearance Type
Special
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 Endo Twinn B.V.

  • K042870 — ENDO TWINN (January 11, 2005)

Other clearances for product code EKM

  • K073369 — EI DOWNPAK BARRIER SLEEVES (February 27, 2008)
  • 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