Cleared Traditional

K925275 - SOFT DENTURE RELINE MATERIAL ELASTOLINE

K925275 is the FDA 510(k) clearance for SOFT DENTURE RELINE MATERIAL ELASTOLINE by Great Lakes Orthodontics, Ltd.. It is a Class 2 Dental device (product code EBI) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K925275 · Great Lakes Orthodontics, Ltd. · Dental device
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Jan 1993
Decision
83d
Days
Class 2
Risk

K925275 is an FDA 510(k) clearance for the SOFT DENTURE RELINE MATERIAL ELASTOLINE. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Great Lakes Orthodontics, Ltd. (Tonawanda, US). The FDA issued a Cleared decision on January 11, 1993 after a review of 83 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 Great Lakes Orthodontics, Ltd. devices

Submission Details

510(k) Number K925275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1992
Decision Date January 11, 1993
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 127d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 124
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K925275.
KOOLINER II
K935261 · GC America, Inc. · Jan 1994
REBARON LC
K930939 · GC America, Inc. · Jan 1994
DUAL CURE RELINE MATERIAL
K926406 · Dentsply Intl. · Mar 1993
PALABOND
K924422 · Heraeus Kulzer, Inc. · Nov 1992
PALADUR
K915898 · Heraeus Kulzer, Inc. · Sep 1992
SR-IVOCAP PLUS
K915377 · Ivoclar North America, Inc. · Jan 1992