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510(k) K964174

MINERAL TRIOXIDE AGGREGATE (MTA) by Tulsa Dental Products, Ltd. — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1997
Date Received
October 18, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Root Canal Filling
Device Class
Class II
Regulation Number
872.3820
Review Panel
DE
Submission Type

Other clearances by Tulsa Dental Products, Ltd.

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  • 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)
  • K881139 — THERMAFIL ENDODONTIC OBTURATOR (April 7, 1988)

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