Home / 510(k) Clearances / K896663

510(k) K896663

ENDO-PREP by Pulpdent Corp. — Product Code EKM

K896663 is an FDA 510(k) premarket notification submitted by Pulpdent Corp. for the device "ENDO-PREP". The FDA issued a decision of Substantially Equivalent on February 14, 1990. The device falls under product code EKM (Gutta-Percha), a Class I device regulated under 21 CFR 872.3850. Pulpdent Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1990
Date Received
November 24, 1989
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 Pulpdent Corp.

  • K014133 — PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE (March 14, 2002)
  • K014138 — PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT (March 14, 2002)
  • K020115 — PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM (February 28, 2002)
  • K014059 — PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE (February 27, 2002)
  • K013411 — PULPDENT CAVITY PREPARATION IV (December 12, 2001)
  • K994180 — PULPDENT CAVITY PREPARATION III (March 2, 2000)
  • K994181 — PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE (February 29, 2000)
  • K994182 — PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE (February 23, 2000)
  • K993683 — PULPDENT UNO-DUO (December 13, 1999)
  • K974202 — PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS (March 19, 1998)

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