Cleared Traditional

K833434 - CERAMCO * HIGH FUSING FOIL SOLDER

K833434 is an FDA 510(k) clearance for CERAMCO * HIGH FUSING FOIL SOLDER, manufactured by Johnson & Johnson Professionals, Inc.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K833434 · Johnson & Johnson Professionals, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K833434

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.

EJS Device Classification - Class 2, Special Controls

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 171
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K833434.
RX ELAN
K840561 · Jeneric Ind. · May 1984
RX C & B 20
K840563 · Jeneric Ind. · May 1984
NATURELLE II & LITE II-N72-N74-L
K833774 · Jeneric Ind. · Jan 1984
GDC 1448 DEVELOPMENT NAME
K833596 · Deringer-Ney, Inc. · Dec 1983
DEGUPLUS 2
K833445 · Degussa Dental, Inc. · Dec 1983
PALLADENT
K833049 · Jeneric Ind. · Oct 1983