Cleared Traditional

K881354 - RAJAH

K881354 is the FDA 510(k) clearance for RAJAH by J.F. Jelenko & Co., Inc.. It is a Class 2 Dental device (product code EJT) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K881354 · J.F. Jelenko & Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1988
Decision
19d
Days
Class 2
Risk

K881354 is an FDA 510(k) clearance for the RAJAH. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by J.F. Jelenko & Co., Inc. (Armonk, US). The FDA issued a Cleared decision on April 18, 1988 after a review of 19 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 K881354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1988
Decision Date April 18, 1988
Days to Decision 19 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
108d faster than avg
Panel avg: 127d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJT Alloy, Gold-based 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 - EJT Alloy, Gold-based Noble Metal

All 435
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K881354.
OLYMPIA II
K881860 · J.F. Jelenko & Co., Inc. · Jun 1988
PTM-45
K881861 · J.F. Jelenko & Co., Inc. · Jun 1988
PALLADIUM-BASED DENTAL ALLOYS FOR PORCELAIN APPLI.
K880348 · J.F. Jelenko & Co., Inc. · May 1988
NEY-ORO 41
K870677 · Deringer-Ney, Inc. · May 1987
GDC 1824
K865049 · Deringer-Ney, Inc. · Mar 1987
NEY-ORO 60
K831280 · Deringer-Ney, Inc. · Jun 1983