Cleared Traditional

K812119 - NIMETIC-DISPERS

K812119 is an FDA 510(k) clearance for NIMETIC-DISPERS, manufactured by Espe-Premier Sales Co.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K812119 · Espe-Premier Sales Co. · Dental device
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Aug 1981
Decision
35d
Days
Class 2
Risk

K812119 is an FDA 510(k) clearance for the NIMETIC-DISPERS. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Espe-Premier Sales Co. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1981 after a review of 35 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 Espe-Premier Sales Co. devices

FDA 510(k) Submission Details - K812119

510(k) Number K812119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1981
Decision Date August 31, 1981
Days to Decision 35 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 128d · This submission: 35d
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 821
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K812119.
ESTILUX POSTERIOR
K812889 · Kulzer, Inc. · Nov 1981
ADAPTIC* C.F.S.
K812449 · Johnson & Johnson Professionals, Inc. · Sep 1981
VISIO-FIL
K812169 · Espe GmbH (Us) · Sep 1981
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