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510(k) K950237

DIGITEST by Parkell, Inc. — Product Code EAT

K950237 is an FDA 510(k) premarket notification submitted by Parkell, Inc. for the device "DIGITEST". The FDA issued a decision of Substantially Equivalent on June 9, 1995. The device falls under product code EAT (Tester, Pulp), a Class II device regulated under 21 CFR 872.1720. Parkell, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1995
Date Received
January 20, 1995
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 Parkell, Inc.

  • K243254 — Parkell Pit and Fissure Sealant (August 8, 2025)
  • K210259 — Parkell Self-Adhesive Cement (January 20, 2022)
  • K191103 — Parkell Desensitizer Gel (November 22, 2019)
  • K190930 — SmarTemp X1 (September 5, 2019)
  • K182296 — HyperFil-LV (December 14, 2018)
  • K172176 — Parkell Universal Adhesive (November 21, 2017)
  • K151518 — BRUSH&BOND PLUS (September 18, 2015)
  • K142848 — EAZY PRIMER (February 24, 2015)
  • K132115 — ABSOLUTE DENTIN 2 (June 25, 2014)
  • K113839 — RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE (April 12, 2012)

Other clearances for product code EAT

  • K022097 — THERMIQUE (September 6, 2002)
  • K021298 — ELEMENTS DIAGNOSTIC UNIT (June 19, 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)
  • K950238 — GENTAL PULSE (May 9, 1995)

FDA data resources