Cleared Traditional

K863876 - OMNI-FIL

K863876 is an FDA 510(k) clearance for OMNI-FIL, manufactured by Inpromas. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K863876 · Inpromas · Dental device
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Nov 1986
Decision
51d
Days
Class 2
Risk

K863876 is an FDA 510(k) clearance for the OMNI-FIL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Inpromas (Miami, US). The FDA issued a Cleared decision on November 26, 1986 after a review of 51 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 Inpromas devices

FDA 510(k) Submission Details - K863876

510(k) Number K863876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1986
Decision Date November 26, 1986
Days to Decision 51 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 128d · This submission: 51d
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 818
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K863876.
ADAPTALITE* PORCELAIN VENEER CEMENTATION SYSTEM
K871295 · Johnson & Johnson Professionals, Inc. · May 1987
ESPE CHELON-SILVER
K865028 · Espe GmbH (Us) · Feb 1987
REMBRANDT PORCELAIN TINTING KIT
K864346 · Den-Mat Corp. · Jan 1987
OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE
K863882 · Coe Laboratories, Inc. · Nov 1986
RECOVER
K863401 · Scientific Pharmaceuticals, Inc. · Nov 1986
IMPROVED COMSPAN
K863552 · Dentsply Intl. · Oct 1986