Cleared Traditional

CERAMCO * HIGH FUSING FOIL SOLDER (K833434) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K833434 · Johnson & Johnson Professionals, Inc. · Dental device
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Dec 1983
Decision
85d
Days
Class 2
Risk

K833434 is an FDA 510(k) clearance for the CERAMCO * HIGH FUSING FOIL SOLDER. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on December 29, 1983 after a review of 85 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K833434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1983
Decision Date December 29, 1983
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 127d · This submission: 85d
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 23
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K833434.
ARGENCO III
K903009 · Argen Precious Metals, Inc. · Aug 1990
ARGENCO 34
K903060 · Argen Precious Metals, Inc. · Aug 1990
ARGENCO Y (TYPE III/IV DENTAL ALLOY CROWN/BRIDGE
K902665 · Argen Precious Metals, Inc. · Aug 1990
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