Cleared Traditional

K884038 - FIBERLITE

K884038 is an FDA 510(k) clearance for FIBERLITE, manufactured by Jeneric/Pentron, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K884038 · Jeneric/Pentron, Inc. · Dental device
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Dec 1988
Decision
72d
Days
Class 2
Risk

K884038 is an FDA 510(k) clearance for the FIBERLITE, FIBERLITE HS AND FIBERSEAL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on December 7, 1988 after a review of 72 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 Jeneric/Pentron, Inc. devices

FDA 510(k) Submission Details - K884038

510(k) Number K884038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1988
Decision Date December 07, 1988
Days to Decision 72 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
55d faster than avg
Panel avg: 127d · This submission: 72d
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 645
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K884038.
UNIREST LC PAINT-ON RESTORATIVE & VENEER CEMENT
K884681 · Scientific Pharmaceuticals, Inc. · Jan 1989
UNIREST PL, ANTE./POST. RESTORATIVE, PASTE/LIQUID
K884351 · Scientific Pharmaceuticals, Inc. · Dec 1988
SMILE-DENT ANTE./POST. RESTORATIVE, LIGHT-CURED
K884352 · Scientific Pharmaceuticals, Inc. · Dec 1988
VISIO-PERL
K882566 · Espe GmbH (Us) · Oct 1988
LUMINBOND, BONDING AND CEMENTATION SYSTEM
K883392 · Scientific Pharmaceuticals, Inc. · Oct 1988
FORTIFY
K882915 · Bisco, Inc. · Aug 1988