Cleared Traditional

K894092 - DENTAL ENDODONTIC CEMENT (MODIFICATION)

K894092 is the FDA 510(k) clearance for DENTAL ENDODONTIC CEMENT (MODIFICATION) by The Hygenic Corp.. It is a Class 2 Dental device (product code KIF) cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K894092 · The Hygenic Corp. · Dental device
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Jan 1990
Decision
216d
Days
Class 2
Risk

K894092 is an FDA 510(k) clearance for the DENTAL ENDODONTIC CEMENT (MODIFICATION). Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by The Hygenic Corp. (Akron, US). The FDA issued a Cleared decision on January 10, 1990 after a review of 216 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - 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

Submission Details

510(k) Number K894092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1989
Decision Date January 10, 1990
Days to Decision 216 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 127d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
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.

Regulatory Peers - KIF Resin, Root Canal Filling

All 83
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K894092.
ROOT CANAL FILLING CEMENT
K914325 · Confi-Dental Products Co. · Mar 1992
ROOT CANAL SEALER, GROOSMANS' FORMULA BISMUTH
K896656 · Pulpdent Corp. · Feb 1990
ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA
K896657 · Pulpdent Corp. · Feb 1990
ROOT CANAL FILLING RESIN
K854253 · Dentsply Intl. · Dec 1985
ROOT CANAL FILLING RESIN
K820284 · Dentsply Intl. · Mar 1982
LEE ENDOFILL, ROOT CANAL FILLING RESIN
K810923 · Lee Pharmaceuticals · Apr 1981