Cleared Traditional

K884222 - CURING LIGHT COVER

K884222 is an FDA 510(k) clearance for CURING LIGHT COVER, manufactured by Steri-Shield Products, Inc.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K884222 · Steri-Shield Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1989
Decision
162d
Days
Class 2
Risk

K884222 is an FDA 510(k) clearance for the CURING LIGHT COVER. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special 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 872.6070 - 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 - K884222

510(k) Number K884222 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. No clinical trials required.

EBZ Device Classification - Class 2, Special Controls

Product Code EBZ Activator, Ultraviolet, For Polymerization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6070
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 - EBZ Activator, Ultraviolet, For Polymerization

All 166
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K884222.
HELIOLUX VISIBLE CURING LIGHT
K901908 · Ivoclar North America, Inc. · Jul 1990
TULUX-FILTER
K892517 · Espe GmbH (Us) · Aug 1989
KULZER TRANSLUX EC
K892456 · Kulzer, Inc. · Jun 1989
PHOTO-CURING LIGHT
K882145 · Dentsply Intl. · Sep 1988
ORTHOLUX VISIBLE LIGHT CURING UNIT
K880392 · Unitek Corp. · Apr 1988
OP II VISIBLE LIGHT CURING SYSTEM
K854696 · Almore Intl., Inc. · Mar 1986