Cleared Traditional

K860299 - REALOR ALLOY

K860299 is an FDA 510(k) clearance for REALOR ALLOY, manufactured by Degussa Dental, Inc.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K860299 · Degussa Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1986
Decision
48d
Days
Class 2
Risk

K860299 is an FDA 510(k) clearance for the REALOR ALLOY. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Degussa Dental, Inc. (Long Island, US). The FDA issued a Cleared decision on March 17, 1986 after a review of 48 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 Dental, Inc. devices

FDA 510(k) Submission Details - K860299

510(k) Number K860299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1986
Decision Date March 17, 1986
Days to Decision 48 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
79d faster than avg
Panel avg: 127d · This submission: 48d
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 171
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K860299.
ALLOY FOR METAL CROWN & BRIDGE YELLOW PD #46 & #65
K855182 · Williams Gold Refining Co., Inc. · Mar 1986
DW217 #18 CROWN/BRIDGE & DW218 #24 CERAMIC ALLOYS
K860439 · Williams Gold Refining Co., Inc. · Mar 1986
GDC 1742 (A CASTING ALLOY FOR DENTAL RESTORATIONS)
K860119 · Deringer-Ney, Inc. · Mar 1986
ALLOY 7
K852093 · Williams Gold Refining Co., Inc. · Aug 1985
DENTAL CASTING ALLOY GDC 1686
K852347 · Deringer-Ney, Inc. · Jul 1985
SPARTAN -ALLOY FOR PORCELAIN FUSED TO METAL
K850699 · Williams Gold Refining Co., Inc. · Mar 1985