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510(k) K922931

THERMAPOST ENDODONTIC ROOT CANAL POST by Tulsa Dental Products, Ltd. — Product Code ELR

K922931 is an FDA 510(k) premarket notification submitted by Tulsa Dental Products, Ltd. for the device "THERMAPOST ENDODONTIC ROOT CANAL POST". The FDA issued a decision of Substantially Equivalent on May 26, 1994. The device falls under product code ELR (Post, Root Canal), a Class I device regulated under 21 CFR 872.3810. Tulsa Dental Products, Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1994
Date Received
June 17, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Post, Root Canal
Device Class
Class I
Regulation Number
872.3810
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)
  • K933582 — PROFILE SERIES 29 FILES (October 20, 1993)
  • K910224 — THERMAPREP (March 29, 1991)
  • K900986 — THERMAFIL ENDODONTIC OBTURATOR (November 13, 1990)
  • K881139 — THERMAFIL ENDODONTIC OBTURATOR (April 7, 1988)

Other clearances for product code ELR

  • K060075 — FIBER-METAL POST (March 30, 2006)
  • K042848 — FRC POSTEC PLUS (November 22, 2004)
  • K030820 — EVERSTICK POST (May 20, 2003)
  • K020431 — FIBIOCORE (July 3, 2002)
  • K012496 — CARBON POST (May 17, 2002)
  • K013802 — FRC POSTEC (May 1, 2002)
  • K012849 — GLASS POST (March 27, 2002)
  • K012354 — SNOWPOST, SNOWLIGHT (October 10, 2001)
  • K003221 — HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST (October 25, 2000)
  • K003219 — HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST (October 25, 2000)

FDA data resources