Cleared Traditional

K882821 - VITRABOND LIGHT CURE GLASS IONOMER LINER

K882821 is an FDA 510(k) clearance for VITRABOND LIGHT CURE GLASS IONOMER LINER, manufactured by 3M Company. The device is a Class 1 Dental device with product code EKJ cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K882821 · 3M Company · Dental device
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Sep 1988
Decision
69d
Days
Class 1
Risk

K882821 is an FDA 510(k) clearance for the VITRABOND LIGHT CURE GLASS IONOMER LINER. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on September 15, 1988 after a review of 69 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.

FDA 510(k) Submission Details - K882821

510(k) Number K882821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1988
Decision Date September 15, 1988
Days to Decision 69 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 128d · This submission: 69d
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 71
Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K882821.
DENTAL MIRROR RETRACTOR
K885040 · Nu-Lite Retractor, Inc. · Jan 1989
BENDA BRUSH
K885162 · Centrix, Inc. · Jan 1989
BREVET DENTAL INSTRUMENTS
K883126 · Brevet, Inc. · Oct 1988
DENTAL HAND INSTRUMENTS
K883322 · Collagen Corp. · Aug 1988
CENTRIX NEEDLETUBE
K882651 · Centrix, Inc. · Aug 1988
TISSUE PUNCH
K882834 · Tri-Stage, Inc. · Aug 1988
K882821 · VITRABOND LIGHT CURE GLASS IONOMER LINER
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