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510(k) K012427

PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT by Specialites Septodont — Product Code EAT

K012427 is an FDA 510(k) premarket notification submitted by Specialites Septodont for the device "PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT". The FDA issued a decision of Substantially Equivalent on October 9, 2001. The device falls under product code EAT (Tester, Pulp), a Class II device regulated under 21 CFR 872.1720. Specialites Septodont has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2001
Date Received
July 31, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Pulp
Device Class
Class II
Regulation Number
872.1720
Review Panel
DE
Submission Type

Other clearances by Specialites Septodont

  • K010415 — ISODAN (July 23, 2001)
  • K982773 — QUICKSET LIQUID AND POWDER (November 3, 1998)
  • K982671 — SECURALLOY (October 19, 1998)
  • K980633 — ENDOSOLV E (May 1, 1998)
  • K920692 — SEPTOCALCINE ULTRA (April 21, 1992)
  • K915466 — SEPTOPACK TEMPORARY FILLING (February 3, 1992)
  • K915467 — CIMPAT S DENTAL CEMENT (February 3, 1992)
  • K913573 — SAFETY PLUS DENTAL INJECTION NEEDLE (November 7, 1991)
  • K913572 — AUTOPACK NON-EUGENOL PERIODONTAL DRESSING (October 9, 1991)
  • K913574 — SEPTOCAL CAVITY LINER (September 30, 1991)

Other clearances for product code EAT

  • K022097 — THERMIQUE (September 6, 2002)
  • K021298 — ELEMENTS DIAGNOSTIC UNIT (June 19, 2002)
  • K011666 — CHILLIT (August 6, 2001)
  • K990225 — ENDO ANALYZER, MODEL 8005, MODIFIED (February 25, 1999)
  • K973439 — ENDO ANALYZER, MODEL 8005 (December 8, 1997)
  • K970715 — SYSTEM B HEAT SOURCE (April 7, 1997)
  • K963862 — TOUCH N' HEAT (December 2, 1996)
  • K960799 — ORTHO-ICE (May 9, 1996)
  • K950237 — DIGITEST (June 9, 1995)
  • K950238 — GENTAL PULSE (May 9, 1995)

FDA data resources