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510(k) K021298

ELEMENTS DIAGNOSTIC UNIT by Sybron Endo/Analytic — Product Code EAT

K021298 is an FDA 510(k) premarket notification submitted by Sybron Endo/Analytic for the device "ELEMENTS DIAGNOSTIC UNIT". The FDA issued a decision of Substantially Equivalent on June 19, 2002. The device falls under product code EAT (Tester, Pulp), a Class II device regulated under 21 CFR 872.1720. Sybron Endo/Analytic has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2002
Date Received
April 24, 2002
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 Sybron Endo/Analytic

  • K031664 — ELEMENTS OBTURATION UNIT (April 28, 2004)
  • K021253 — ULTRASONIC TIPS WITH DIAMOND COATING (July 5, 2002)

Other clearances for product code EAT

  • K022097 — THERMIQUE (September 6, 2002)
  • K012427 — PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT (October 9, 2001)
  • 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