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510(k) K051573

TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) by Dr. Howard Martin, P.A. — Product Code EKM

K051573 is an FDA 510(k) premarket notification submitted by Dr. Howard Martin, P.A. for the device "TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)". The FDA issued a decision of Substantially Equivalent on June 26, 2006. The device falls under product code EKM (Gutta-Percha), a Class I device regulated under 21 CFR 872.3850. Dr. Howard Martin, P.A. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2006
Date Received
June 14, 2005
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 Dr. Howard Martin, P.A.

  • K973636 — MCS-MEDICATED CANAL SEALER (July 27, 1998)
  • K971641 — ANTIBACTERIAL GUTTA PERCHA (July 21, 1997)

Other clearances for product code EKM

  • K073369 — EI DOWNPAK BARRIER SLEEVES (February 27, 2008)
  • K070246 — DOWN PAK (February 16, 2007)
  • 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)
  • K910224 — THERMAPREP (March 29, 1991)

FDA data resources