Cleared Traditional

K884223 - DENTAL LAMP HANDLE COVER

K884223 is an FDA 510(k) clearance for DENTAL LAMP HANDLE COVER, manufactured by Steri-Shield Products, Inc.. The device is a Class 1 Dental device with product code EAZ cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K884223 · Steri-Shield Products, Inc. · Dental device
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Mar 1989
Decision
162d
Days
Class 1
Risk

K884223 is an FDA 510(k) clearance for the DENTAL LAMP HANDLE COVER. Classified as Light, Operating, Dental (product code EAZ), Class I - General Controls.

Submitted by Steri-Shield Products, Inc. (Allentown, US). The FDA issued a Cleared decision on March 17, 1989 after a review of 162 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4630 - 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 Steri-Shield Products, Inc. devices

FDA 510(k) Submission Details - K884223

510(k) Number K884223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1988
Decision Date March 17, 1989
Days to Decision 162 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 128d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

EAZ Device Classification - Class 1, General Controls

Product Code EAZ Light, Operating, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4630
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EAZ Light, Operating, Dental

All 7
Devices cleared under the same product code (EAZ) and FDA review panel - the closest regulatory comparables to K884223.
MICROLUX DL
K041614 · Addent, Inc. · Apr 2005
DENTAL LIGHT
K926081 · Mdt Corp., Inc. · Jan 1994
A-DEC DENTAL LIGHT
K893044 · A-Dec, Inc. · Jul 1989
F-11 REFLECTOR / F-II STANDARD REFLECTOR
K863019 · Sds Dental, Inc. · Sep 1986
OPTI-BEAM IV
K832919 · Dentsply Intl. · Mar 1984
LUNA-VUE DENTAL OPERATING LIGHT
K801683 · Pacific Dental Corp. · Aug 1980