Cleared Traditional

K981257 - JELFINE-52 (CODE NAME RD-0901)

K981257 is the FDA 510(k) clearance for JELFINE-52 (CODE NAME RD-0901) 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 129-day FDA review.

K981257 · J.F. Jelenko & Co., Inc. · Dental device
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Aug 1998
Decision
129d
Days
Class 2
Risk

K981257 is an FDA 510(k) clearance for the JELFINE-52 (CODE NAME RD-0901). 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 August 13, 1998 after a review of 129 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all J.F. Jelenko & Co., Inc. devices

Submission Details

510(k) Number K981257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1998
Decision Date August 13, 1998
Days to Decision 129 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
2d slower than avg
Panel avg: 127d · This submission: 129d
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 K981257.
D-SIGN III (R&D PROJECT DW264#7)
K990077 · Ivoclar North America, Inc. · Feb 1999
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
SILCAST (CODE NAME RD-0118)
K981247 · J.F. Jelenko & Co., Inc. · Jul 1998
V-DELTA 450
K972683 · Metalor Dental USA Corp. · Aug 1997
AUROFLUID 22
K970044 · Metalor Dental USA Corp. · Mar 1997