Cleared Traditional

K945395 - PREMIER MIRROR WARMER (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K945395 · Premier Dental Products Co. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
76d
Days
Class 1
Risk

K945395 is an FDA 510(k) clearance for the PREMIER MIRROR WARMER. Classified as Unit, Examining/treatment, Ent (product code ETF), Class I - General Controls.

Submitted by Premier Dental Products Co. (Philadelphia, US). The FDA issued a Cleared decision on January 18, 1995 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5300 - the FDA ear, nose and throat device 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 Premier Dental Products Co. devices

Submission Details

510(k) Number K945395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1994
Decision Date January 18, 1995
Days to Decision 76 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 89d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ETF Unit, Examining/treatment, Ent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5300
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.