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510(k) K910224

THERMAPREP by Tulsa Dental Products, Ltd. — Product Code EKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1991
Date Received
January 18, 1991
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

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  • K933582 — PROFILE SERIES 29 FILES (October 20, 1993)
  • K900986 — THERMAFIL ENDODONTIC OBTURATOR (November 13, 1990)
  • K881139 — THERMAFIL ENDODONTIC OBTURATOR (April 7, 1988)

Other clearances for product code EKM

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  • 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)