Cleared Traditional

ENDO-ICE-PULP TESTER-THERMAL

K930764 · The Hygenic Corp. · Dental
May 1993
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K930764 is an FDA 510(k) clearance for the ENDO-ICE-PULP TESTER-THERMAL, a Tester, Pulp (Class II — Special Controls, product code EAT), submitted by The Hygenic Corp. (Akron, US). The FDA issued a Cleared decision on May 27, 1993, 104 days after receiving the submission on February 12, 1993. This device falls under the Dental review panel. Regulated under 21 CFR 872.1720.

Submission Details

510(k) Number K930764 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1993
Decision Date May 27, 1993
Days to Decision 104 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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