Cleared Traditional

K851648 - HERACOR SYSTEM HERACOR PLATINUM FOIL, BLENDGOLD NE

K851648 is an FDA 510(k) clearance for HERACOR SYSTEM HERACOR PLATINUM FOIL, manufactured by Heraeus Dental Gold Corp.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K851648 · Heraeus Dental Gold Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1985
Decision
43d
Days
Class 2
Risk

K851648 is an FDA 510(k) clearance for the HERACOR SYSTEM HERACOR PLATINUM FOIL, BLENDGOLD NE. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Heraeus Dental Gold Corp. (Chicago, US). The FDA issued a Cleared decision on June 4, 1985 after a review of 43 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 Heraeus Dental Gold Corp. devices

FDA 510(k) Submission Details - K851648

510(k) Number K851648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1985
Decision Date June 04, 1985
Days to Decision 43 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 128d · This submission: 43d
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 172
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K851648.
REALOR ALLOY
K860299 · Degussa Dental, 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
GDC-1629 A CASTING ALLOY
K850101 · Deringer-Ney, Inc. · Feb 1985
GDC-1433 A CASTING ALLOY
K850102 · Deringer-Ney, Inc. · Feb 1985