Cleared Traditional

K981247 - SILCAST (CODE NAME RD-0118)

K981247 is an FDA 510(k) clearance for SILCAST (CODE NAME RD-0118), manufactured by J.F. Jelenko & Co., Inc.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K981247 · J.F. Jelenko & Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
86d
Days
Class 2
Risk

K981247 is an FDA 510(k) clearance for the SILCAST (CODE NAME RD-0118). Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by J.F. Jelenko & Co., Inc. (Armonk, US). The FDA issued a Cleared decision on July 1, 1998 after a review of 86 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 J.F. Jelenko & Co., Inc. devices

FDA 510(k) Submission Details - K981247

510(k) Number K981247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1998
Decision Date July 01, 1998
Days to Decision 86 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
41d faster than avg
Panel avg: 127d · This submission: 86d
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 K981247.
BEGOPAL 300
K983081 · Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO · Oct 1998
BEGOPAL
K983078 · Bego U.S.A. · Oct 1998
JELFINE-52 (CODE NAME RD-0901)
K981257 · J.F. Jelenko & Co., Inc. · Aug 1998
ORION VESTA DENTAL ALLOY
K981001 · European Dental Imports, Inc. · May 1998
ORION WX DENTAL ALLOY
K981002 · European Dental Imports, Inc. · May 1998
CERA E DENTAL ALLOY
K980661 · European Dental Imports, Inc. · May 1998