Cleared Traditional

K962374 - FIBER-SPLINT ML MULTILAYER

K962374 is an FDA 510(k) clearance for FIBER-SPLINT ML MULTILAYER, manufactured by Polydentia USA. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K962374 · Polydentia USA · Dental device
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Jul 1996
Decision
32d
Days
Class 2
Risk

K962374 is an FDA 510(k) clearance for the FIBER-SPLINT ML MULTILAYER. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Polydentia USA (Chicago, US). The FDA issued a Cleared decision on July 22, 1996 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 Polydentia USA devices

FDA 510(k) Submission Details - K962374

510(k) Number K962374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1996
Decision Date July 22, 1996
Days to Decision 32 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 127d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 217
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K962374.
SOFT DENTURE REBASING RESIN
K963736 · Sybron Dental Specialties, Inc. · Dec 1996
GC BASELINE
K963144 · GC America, Inc. · Oct 1996
V.R.S. DENTURE RESIN MATERIAL
K962333 · Vident · Aug 1996
QUICKSPLINT
K961995 · Heraeus Kulzer, Inc. · Jun 1996
BOSWORTH LIQUID RESIN II
K961200 · Harry J. Bosworth Co. · May 1996
TOKUYAMA SOFT RELINING
K953589 · Tokuyama America, Inc. · Jan 1996