Cleared Traditional

K832425 - GREAT LAKES PASTE SOLDER

K832425 is the FDA 510(k) clearance for GREAT LAKES PASTE SOLDER by Great Lakes Orthodontics, Ltd.. It is a Class 2 Dental device (product code EJS) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K832425 · Great Lakes Orthodontics, Ltd. · Dental device
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Oct 1983
Decision
74d
Days
Class 2
Risk

K832425 is an FDA 510(k) clearance for the GREAT LAKES PASTE SOLDER. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Great Lakes Orthodontics, Ltd. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1983 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - 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 K832425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1983
Decision Date October 04, 1983
Days to Decision 74 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 127d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJS Alloy, Other Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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 - EJS Alloy, Other Noble Metal

All 81
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K832425.
PROTOCOL (ALLOY)
K901099 · Ivoclar North America, Inc. · Apr 1990
RX APF (CASTING ALLOY)
K890811 · Jeneric/Pentron, Inc. · Mar 1989
CERAMCO * HIGH FUSING FOIL SOLDER
K833434 · Johnson & Johnson Professionals, Inc. · Dec 1983
T-IV ELITE ALLOY
K820530 · Howmedica Corp. · Mar 1982
CLASS OF CASTING ALLOYS TYPE I OR ALTER
K820432 · Howmedica Corp. · Mar 1982
CLASS OF CASTING ALLOYS TYPE II OR ALTER
K820433 · Howmedica Corp. · Mar 1982