Cleared Traditional

ENDO-ICE

K881826 · The Hygenic Corp. · Dental
Aug 1988
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K881826 is an FDA 510(k) clearance for the ENDO-ICE, a Tester, Pulp (Class II — Special Controls, product code EAT), submitted by The Hygenic Corp. (Akron, US). The FDA issued a Cleared decision on August 23, 1988, 116 days after receiving the submission on April 29, 1988. This device falls under the Dental review panel. Regulated under 21 CFR 872.1720.

Submission Details

510(k) Number K881826 FDA.gov
FDA Decision Cleared SN
Date Received April 29, 1988
Decision Date August 23, 1988
Days to Decision 116 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