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510(k) K971641

ANTIBACTERIAL GUTTA PERCHA by Dr. Howard Martin, P.A. — Product Code EKM

K971641 is an FDA 510(k) premarket notification submitted by Dr. Howard Martin, P.A. for the device "ANTIBACTERIAL GUTTA PERCHA". The FDA issued a decision of Substantially Equivalent on July 21, 1997. 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
July 21, 1997
Date Received
May 2, 1997
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.

  • K051573 — TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) (June 26, 2006)
  • K973636 — MCS-MEDICATED CANAL SEALER (July 27, 1998)

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)
  • 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