Cleared Traditional

K983461 - UNI-FLEX RESIN

K983461 is an FDA 510(k) clearance for UNI-FLEX RESIN, manufactured by Trans-Atlantic Dental. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K983461 · Trans-Atlantic Dental · Dental device
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Apr 1999
Decision
194d
Days
Class 2
Risk

K983461 is an FDA 510(k) clearance for the UNI-FLEX RESIN. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Trans-Atlantic Dental (Trenton, US). The FDA issued a Cleared decision on April 13, 1999 after a review of 194 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Trans-Atlantic Dental devices

FDA 510(k) Submission Details - K983461

510(k) Number K983461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1998
Decision Date April 13, 1999
Days to Decision 194 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
67d slower than avg
Panel avg: 127d · This submission: 194d
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 204
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K983461.
VITRON M
K990763 · Espe Dental AG · May 1999
VITRON H
K991220 · Espe Dental AG · May 1999
ORTHO-GLOW GLITTER
K990699 · Harry J. Bosworth Co. · May 1999
JELDENT MULTICRYL
K990056 · J.F. Jelenko & Co., Inc. · Mar 1999
THE.R.MO.FREE
K990448 · Dentamax, Inc. · Mar 1999
GC UNIFAST TRAD
K984365 · GC America, Inc. · Feb 1999