PULP PEN— 510(k) K873644

Substantially Equivalent

The Hygenic Corp.

FDA 510(k) clearance K873644 for PULP PEN, Substantially Equivalent on 1987-10-27. Applicant: The Hygenic Corp.. Device class: 2.

Clearance details

Applicant: The Hygenic Corp.
Product code: Code EAT
Device class: Class 2
Regulation: 21 CFR 872.1720
Advisory panel: Dental
Date received: 1987-09-09
Decision date: 1987-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EAT

K022097 — THERMIQUE2002-09-06
K021298 — ELEMENTS DIAGNOSTIC UNIT2002-06-19
K012427 — PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT2001-10-09
K011666 — CHILLIT2001-08-06
K990225 — ENDO ANALYZER, MODEL 8005, MODIFIED1999-02-25

More clearances from The Hygenic Corp.

K954990 — DENTAL DAM1996-01-26
K930764 — ENDO-ICE-PULP TESTER-THERMAL1993-05-27
K905418 — GATES GLIDDEN DRILLS1991-07-25
K911225 — TRAY DOUGH1991-04-17
K905640 — SOLID CORE GUTTA PERCHA CARRIER1991-03-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.