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510(k) K830115

PAPER POINTS by North Pacific Dental, Inc. — Product Code EKM

K830115 is an FDA 510(k) premarket notification submitted by North Pacific Dental, Inc. for the device "PAPER POINTS". The FDA issued a decision of Substantially Equivalent on March 1, 1983. The device falls under product code EKM (Gutta-Percha), a Class I device regulated under 21 CFR 872.3850. North Pacific Dental, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1983
Date Received
January 11, 1983
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 North Pacific Dental, Inc.

  • K830113 — SEPTOPACK (May 9, 1983)
  • K830111 — SEPTOCAL (March 24, 1983)
  • K830106 — UNICIDE (March 7, 1983)
  • K830109 — CIMPAT (March 1, 1983)
  • K830105 — VITATHYL (March 1, 1983)
  • K830117 — ENDOMET (March 1, 1983)
  • K830114 — GUTTA PERCHA POINTS (March 1, 1983)
  • K830107 — SELFAST (February 18, 1983)
  • K830116 — SULCARINGS (February 18, 1983)
  • K830112 — HYDROL (February 18, 1983)

Other clearances for product code EKM

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

FDA data resources