Cleared Traditional

K981247 - SILCAST (CODE NAME RD-0118)

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

K981247 · J.F. Jelenko & Co., Inc. · Dental device
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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

Submission Details

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.

Device Classification

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 117
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K981247.
D-SIGN IV (R&D PROJECT DW265#37)
K990078 · Ivoclar North America, Inc. · Feb 1999
D-SIGN I (R&D PROJECT DW263 #24)
K984451 · Ivoclar North America, Inc. · Jan 1999
JELFINE-52 (CODE NAME RD-0901)
K981257 · J.F. Jelenko & Co., Inc. · Aug 1998
V-DELTA 450
K972683 · Metalor Dental USA Corp. · Aug 1997
AUROFLUID 22
K970044 · Metalor Dental USA Corp. · Mar 1997
SOLARO 33
K970045 · Metalor Dental USA Corp. · Mar 1997