Cleared Traditional

K810595 - SILUX RESTORATIVE MATERIAL & ENAMEL BOND

K810595 is an FDA 510(k) clearance for SILUX RESTORATIVE MATERIAL & ENAMEL BOND, 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 18-day FDA review.

K810595 · 3M Company · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1981
Decision
18d
Days
Class 2
Risk

K810595 is an FDA 510(k) clearance for the SILUX RESTORATIVE MATERIAL & ENAMEL BOND. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on March 24, 1981 after a review of 18 days - a notably fast clearance 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: 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 3M Company devices

FDA 510(k) Submission Details - K810595

510(k) Number K810595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1981
Decision Date March 24, 1981
Days to Decision 18 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
109d faster than avg
Panel avg: 127d · This submission: 18d
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 785
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K810595.
SUPERFIL LIGHT & SUPERFIL BONDING SYSTEM
K811427 · Harry J. Bosworth Co. · Aug 1981
DURAFILL MICROFILL RESTORATIVE MATERIAL
K811669 · Kulzer, Inc. · Jul 1981
ENHANCE DENTAL RESTORATIVE
K811443 · Johnson & Johnson Professionals, Inc. · Jun 1981
ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE
K802975 · Dentsply Intl. · Jan 1981
HYDROXYLATE DENTAL COMPOSITE RESTROATIVE
K802535 · Wallace A. Erickson & Co. · Dec 1980
HELIOSIT
K802683 · Vivadent (Usa), Inc. · Nov 1980