Cleared Traditional

K885040 - DENTAL MIRROR RETRACTOR

K885040 is an FDA 510(k) clearance for DENTAL MIRROR RETRACTOR, manufactured by Nu-Lite Retractor, Inc.. The device is a Class 1 Dental device with product code EKJ cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K885040 · Nu-Lite Retractor, Inc. · Dental device
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Jan 1989
Decision
36d
Days
Class 1
Risk

K885040 is an FDA 510(k) clearance for the DENTAL MIRROR RETRACTOR. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Nu-Lite Retractor, Inc. (Forest Hills, US). The FDA issued a Cleared decision on January 10, 1989 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Nu-Lite Retractor, Inc. devices

FDA 510(k) Submission Details - K885040

510(k) Number K885040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1988
Decision Date January 10, 1989
Days to Decision 36 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 128d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

EKJ Device Classification - Class 1, General Controls

Product Code EKJ Burnisher, Operative
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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 - EKJ Burnisher, Operative

All 23
Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K885040.
PRICHARD PERIOSTEAL RETRACTOR #3
K892260 · Zinnanti Surgical Instruments, Inc. · May 1989
DENTAL SYRINGE APPLICATION TIP
K890064 · Centrix, Inc. · Feb 1989
RACESTYPTINE
K884653 · Specialites Septodont · Jan 1989
BENDA BRUSH
K885162 · Centrix, Inc. · Jan 1989
VITRABOND LIGHT CURE GLASS IONOMER LINER
K882821 · 3M Company · Sep 1988
CENTRIX NEEDLETUBE
K882651 · Centrix, Inc. · Aug 1988