Cleared Traditional

DEGUBOND ULTRA (K953344) - FDA 510(k) Clearance

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

K953344 · Degussa AG · Dental device
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Aug 1995
Decision
44d
Days
Class 2
Risk

K953344 is an FDA 510(k) clearance for the DEGUBOND ULTRA. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Degussa AG (South Plainfield, US). The FDA issued a Cleared decision on August 25, 1995 after a review of 44 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 Degussa AG devices

Submission Details

510(k) Number K953344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1995
Decision Date August 25, 1995
Days to Decision 44 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 127d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

Regulatory Peers - EJT Alloy, Gold-based Noble Metal

All 208
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K953344.
ARGEDENT BIO 87 PF
K954368 · Argen Precious Metals, Inc. · Oct 1995
SUREFIRE S
K954371 · Argen Precious Metals, Inc. · Oct 1995
AUROLITE 45
K954404 · Argen Precious Metals, Inc. · Oct 1995
AUROLITE 80
K952403 · Argen Precious Metals, Inc. · Jun 1995
AURIUM 68M
K952402 · Argen Precious Metals, Inc. · Jun 1995
AUROLITE 55
K950858 · Argen Precious Metals, Inc. · Mar 1995