Cleared Traditional

K881826 - ENDO-ICE

K881826 is an FDA 510(k) clearance for ENDO-ICE, manufactured by The Hygenic Corp.. The device is a Class 2 Dental device with product code EAT cleared through the Traditional 510(k) pathway after a 116-day FDA review.

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

K881826 is an FDA 510(k) clearance for the ENDO-ICE. Classified as Tester, Pulp (product code EAT), Class II - Special Controls.

Submitted by The Hygenic Corp. (Akron, US). The FDA issued a Cleared decision on August 23, 1988 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1720 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all The Hygenic Corp. devices

FDA 510(k) Submission Details - K881826

510(k) Number K881826 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 29, 1988
Decision Date August 23, 1988
Days to Decision 116 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 127d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EAT Device Classification - Class 2, Special Controls

Product Code EAT Tester, Pulp
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.