Cleared Traditional

K891216 - DENTAL EQUIPMENT PROTECTION DEVICES

K891216 is an FDA 510(k) clearance for DENTAL EQUIPMENT PROTECTION DEVICES, manufactured by Pro-Safe Professional Linens, Inc.. The device is a Class 1 Dental device with product code EAZ cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K891216 · Pro-Safe Professional Linens, Inc. · Dental device
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Jun 1989
Decision
87d
Days
Class 1
Risk

K891216 is an FDA 510(k) clearance for the DENTAL EQUIPMENT PROTECTION DEVICES. Classified as Light, Operating, Dental (product code EAZ), Class I - General Controls.

Submitted by Pro-Safe Professional Linens, Inc. (Grand Junction, US). The FDA issued a Cleared decision on June 2, 1989 after a review of 87 days - a notably fast clearance 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: 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 Pro-Safe Professional Linens, Inc. devices

FDA 510(k) Submission Details - K891216

510(k) Number K891216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1989
Decision Date June 02, 1989
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 128d · This submission: 87d
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 K891216.
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