Cleared Traditional

K955027 - DEGUBOND X-LITE

K955027 is an FDA 510(k) clearance for DEGUBOND X-LITE, manufactured by Degussa Corp.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K955027 · Degussa Corp. · Dental device
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Dec 1995
Decision
29d
Days
Class 2
Risk

K955027 is an FDA 510(k) clearance for the DEGUBOND X-LITE. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Degussa Corp. (South Plainfield, US). The FDA issued a Cleared decision on December 1, 1995 after a review of 29 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 Corp. devices

FDA 510(k) Submission Details - K955027

510(k) Number K955027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1995
Decision Date December 01, 1995
Days to Decision 29 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 127d · This submission: 29d
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.

Regulatory Peers - EJT Alloy, Gold-based Noble Metal

All 489
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K955027.
DG 88
K960226 · Degussa Corp. · Feb 1996
BIOCCLUS 4
K960104 · Degussa Corp. · Feb 1996
DEGUBOND X-LITE PLUS
K955118 · Degussa Corp. · Dec 1995
DW260 19
K954837 · Ivoclar North America, Inc. · Nov 1995
IMPLANTALOY
K954702 · Metalor Dental USA Corp. · Oct 1995
ARGISTAR 74
K954362 · Argen Precious Metals, Inc. · Oct 1995