Cleared Traditional

PULP PEN

K873644 · The Hygenic Corp. · Dental
Oct 1987
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K873644 is an FDA 510(k) clearance for the PULP PEN, a Tester, Pulp (Class II — Special Controls, product code EAT), submitted by The Hygenic Corp. (Akron, US). The FDA issued a Cleared decision on October 27, 1987, 48 days after receiving the submission on September 9, 1987. This device falls under the Dental review panel. Regulated under 21 CFR 872.1720.

Submission Details

510(k) Number K873644 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 1987
Decision Date October 27, 1987
Days to Decision 48 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EAT — Tester, Pulp
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1720