Cleared Traditional

K904927 - HENNSON INTERNATIONAL DENTAL CAD/CAM SYSTEM

K904927 is an FDA 510(k) clearance for HENNSON INTERNATIONAL DENTAL CAD/CAM SYSTEM, manufactured by Hennson Intl., Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K904927 · Hennson Intl., Inc. · Dental device
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Dec 1990
Decision
58d
Days
Class 2
Risk

K904927 is an FDA 510(k) clearance for the HENNSON INTERNATIONAL DENTAL CAD/CAM SYSTEM. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Hennson Intl., Inc. (Washington, US). The FDA issued a Cleared decision on December 28, 1990 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hennson Intl., Inc. devices

FDA 510(k) Submission Details - K904927

510(k) Number K904927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1990
Decision Date December 28, 1990
Days to Decision 58 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 127d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 330
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K904927.
CUTTERSIL XL
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K910360 · Heraeus Kulzer, Inc. · Jun 1991
STAT.BR TM
K904482 · Kerr Corporation (Danbury) · Nov 1990
ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS
K903292 · Coe Laboratories, Inc. · Oct 1990
DEGUFLEX (R) CS LIGHT
K901866 · Degussa AG · Sep 1990