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510(k) K881139

THERMAFIL ENDODONTIC OBTURATOR by Tulsa Dental Products, Ltd. — Product Code EKM

K881139 is an FDA 510(k) premarket notification submitted by Tulsa Dental Products, Ltd. for the device "THERMAFIL ENDODONTIC OBTURATOR". The FDA issued a decision of Substantially Equivalent on April 7, 1988. The device falls under product code EKM (Gutta-Percha), a Class I device regulated under 21 CFR 872.3850. Tulsa Dental Products, Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1988
Date Received
March 17, 1988
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 Tulsa Dental Products, Ltd.

  • K970134 — THERMAPREP PLUS OVEN (March 21, 1997)
  • K964174 — MINERAL TRIOXIDE AGGREGATE (MTA) (February 10, 1997)
  • K954790 — PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS (January 16, 1996)
  • K922931 — THERMAPOST ENDODONTIC ROOT CANAL POST (May 26, 1994)
  • K933582 — PROFILE SERIES 29 FILES (October 20, 1993)
  • K910224 — THERMAPREP (March 29, 1991)
  • K900986 — THERMAFIL ENDODONTIC OBTURATOR (November 13, 1990)

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