Cleared Traditional

K950187 - FUTURA ONE

K950187 is an FDA 510(k) clearance for FUTURA ONE, 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 66-day FDA review.

K950187 · Degussa Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
66d
Days
Class 2
Risk

K950187 is an FDA 510(k) clearance for the FUTURA ONE. 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 March 24, 1995 after a review of 66 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 - K950187

510(k) Number K950187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1995
Decision Date March 24, 1995
Days to Decision 66 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 127d · This submission: 66d
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 K950187.
DEGUDENT U
K951778 · Degussa Corp. · May 1995
HARMONY LINE KF
K951297 · Ivoclar North America, Inc. · Apr 1995
MAXIGOLD KF
K951298 · Ivoclar North America, Inc. · Apr 1995
HARMONY LINE PF
K950517 · Ivoclar North America, Inc. · Mar 1995
AUROLITE 55
K950858 · Argen Precious Metals, Inc. · Mar 1995
ARGELITE 61 (PALLADIUM - SILVER DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS)
K950772 · Argen Precious Metals, Inc. · Mar 1995