Cleared Traditional

K882170 - RX ASPEN

K882170 is an FDA 510(k) clearance for RX ASPEN, manufactured by Jeneric/Pentron, Inc.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K882170 · Jeneric/Pentron, Inc. · Dental device
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Jun 1988
Decision
24d
Days
Class 2
Risk

K882170 is an FDA 510(k) clearance for the RX ASPEN. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on June 17, 1988 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3710 - 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 Jeneric/Pentron, Inc. devices

FDA 510(k) Submission Details - K882170

510(k) Number K882170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1988
Decision Date June 17, 1988
Days to Decision 24 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
103d faster than avg
Panel avg: 127d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJH Device Classification - Class 2, Special Controls

Product Code EJH Alloy, Metal, Base
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3710
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 - EJH Alloy, Metal, Base

All 79
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K882170.
WIRON 99 DENTAL CASTING ALLOY
K903538 · Leach and Dillon Co., Inc. · Mar 1991
VIDENT 90 ALLOY AND VIDENT 95 ALLOY
K903008 · Vident · Sep 1990
TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS)
K896501 · Leach and Dillon Co., Inc. · Feb 1990
NPG NONPRECIOUS CROWN AND BRIDGE ALLOY
K863782 · Aalba Dent, Inc. · Nov 1986
REXILLIUM N. B. F.
K862822 · Jeneric Ind. · Sep 1986
RESISTAL P
K862870 · Degussa Dental, Inc. · Aug 1986