Cleared Traditional

K821832 - DEGUCAST U

K821832 is an FDA 510(k) clearance for DEGUCAST U, manufactured by J. Aderer, Inc.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K821832 · J. Aderer, Inc. · Dental device
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Jul 1982
Decision
14d
Days
Class 2
Risk

K821832 is an FDA 510(k) clearance for the DEGUCAST U. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by J. Aderer, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1982 after a review of 14 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 J. Aderer, Inc. devices

FDA 510(k) Submission Details - K821832

510(k) Number K821832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1982
Decision Date July 06, 1982
Days to Decision 14 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
113d faster than avg
Panel avg: 127d · This submission: 14d
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 156
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K821832.
RX UNIVERSAL
K822950 · Jeneric Ind. · Oct 1982
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K822419 · Williams Gold Refining Co., Inc. · Aug 1982
82 ALLOY
K821798 · J. Aderer, Inc. · Jul 1982
DUALLOR 'R'
K821572 · J. Aderer, Inc. · Jun 1982
PORS-ON
K821590 · J. Aderer, Inc. · Jun 1982
DEVA M
K821407 · J. Aderer, Inc. · Jun 1982