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510(k) K873644

PULP PEN by The Hygenic Corp. — Product Code EAT

K873644 is an FDA 510(k) premarket notification submitted by The Hygenic Corp. for the device "PULP PEN". The FDA issued a decision of Substantially Equivalent on October 27, 1987. The device falls under product code EAT (Tester, Pulp), a Class II device regulated under 21 CFR 872.1720. The Hygenic Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1987
Date Received
September 9, 1987
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 The Hygenic Corp.

  • K954990 — DENTAL DAM (January 26, 1996)
  • K930764 — ENDO-ICE-PULP TESTER-THERMAL (May 27, 1993)
  • K905418 — GATES GLIDDEN DRILLS (July 25, 1991)
  • K911225 — TRAY DOUGH (April 17, 1991)
  • K905640 — SOLID CORE GUTTA PERCHA CARRIER (March 5, 1991)
  • K900301 — NOVUS BONDING AGENT (May 15, 1990)
  • K900844 — WEDJETS (April 16, 1990)
  • K894092 — DENTAL ENDODONTIC CEMENT (MODIFICATION) (January 10, 1990)
  • K881826 — ENDO-ICE (August 23, 1988)
  • K863393 — ENDOCATER (June 11, 1987)

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)
  • K950237 — DIGITEST (June 9, 1995)

FDA data resources