Cleared Traditional

K821446 - DEGUDENT 14

K821446 is an FDA 510(k) clearance for DEGUDENT 14, manufactured by J. Aderer, Inc.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K821446 · J. Aderer, Inc. · Dental device
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Jun 1982
Decision
26d
Days
Class 2
Risk

K821446 is an FDA 510(k) clearance for the DEGUDENT 14. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by J. Aderer, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1982 after a review of 26 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 - K821446

510(k) Number K821446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1982
Decision Date June 09, 1982
Days to Decision 26 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
101d faster than avg
Panel avg: 127d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJT Device Classification - Class 2, Special Controls

Product Code EJT Alloy, Gold-based 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.