Cleared Traditional

K833797 - LIGHT CURED RESIN BONDED CERAMIC

K833797 is an FDA 510(k) clearance for LIGHT CURED RESIN BONDED CERAMIC, manufactured by 3M Company. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K833797 · 3M Company · Dental device
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Apr 1984
Decision
176d
Days
Class 2
Risk

K833797 is an FDA 510(k) clearance for the LIGHT CURED RESIN BONDED CERAMIC. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by 3M Company (Monrovia, US). The FDA issued a Cleared decision on April 25, 1984 after a review of 176 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 3M Company devices

FDA 510(k) Submission Details - K833797

510(k) Number K833797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1983
Decision Date April 25, 1984
Days to Decision 176 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
49d slower than avg
Panel avg: 127d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 784
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K833797.
SCOTCHBOND LIGHT CURED DENTAL ADHES
K841550 · 3M Company · Jun 1984
WUNDERFIL
K841667 · Harry J. Bosworth Co. · May 1984
JOHNSON & JOHNSON POSTERIOR DENTAL (ADAPTIC II)
K841518 · Johnson & Johnson Professionals, Inc. · May 1984
ESTIC MICROFILL
K840176 · Kulzer, Inc. · Apr 1984
PRE-LOADED C-R TUBES FOR SYRINGE
K833725 · Centrix, Inc. · Mar 1984
REMBRANDT SHADE MODIFICATION KIT
K841111 · Den-Mat Corp. · Mar 1984