Cleared Traditional

K871497 - LINER OR GSRI-PNF

K871497 is an FDA 510(k) clearance for LINER OR GSRI-PNF, manufactured by Gulf South Research Institute. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K871497 · Gulf South Research Institute · Dental device
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Optimized for regulatory review, auditing and printing
Jun 1987
Decision
62d
Days
Class 2
Risk

K871497 is an FDA 510(k) clearance for the LINER OR GSRI-PNF. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Gulf South Research Institute (New Orleans, US). The FDA issued a Cleared decision on June 17, 1987 after a review of 62 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 Gulf South Research Institute devices

FDA 510(k) Submission Details - K871497

510(k) Number K871497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1987
Decision Date June 17, 1987
Days to Decision 62 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 128d · This submission: 62d
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 265
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K871497.
BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN
K883799 · Austenal Dental, Inc. · Oct 1988
TRIAD ORTHODONTIC GEL
K882482 · Dentsply Intl. · Aug 1988
LIGHT CURE DENTURE GLAZE
K871849 · Austenal Dental, Inc. · Aug 1987
AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL
K863630 · Austenal Dental, Inc. · Mar 1987
AUSTENAL ACUSOFT SOFT LINER
K862557 · Austenal Dental, Inc. · Feb 1987
TRIAD IMPACT
K863324 · Dentsply Intl. · Sep 1986