Cleared Traditional

K934758 - R2+

K934758 is an FDA 510(k) clearance for R2+, 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 137-day FDA review.

K934758 · Jeneric/Pentron, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
137d
Days
Class 2
Risk

K934758 is an FDA 510(k) clearance for the R2+. 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 February 18, 1994 after a review of 137 days - within the typical 510(k) review window.

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: 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 Jeneric/Pentron, Inc. devices

FDA 510(k) Submission Details - K934758

510(k) Number K934758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1993
Decision Date February 18, 1994
Days to Decision 137 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 127d · This submission: 137d
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 K934758.
VERABOND III
K945714 · Aalba Dent, Inc. · Dec 1994
VIDENT 500 ALLOY AND VIDENT 550 BE ALLOY
K932893 · Vident · Mar 1994
LPG 5/10, LPG 10/5, LPG 10/15 AND LPG 15/10
K940749 · Aalba Dent, Inc. · Mar 1994
ARGELOY PARTIAL (NON-PRECIOUS)
K935829 · Argen Precious Metals, Inc. · Jan 1994
ARGELOY N.P. (V) (NON-PRECIOUS DENTAL ALLOY FOR PROCELAIN APPLICATION)
K935972 · Argen Precious Metals, Inc. · Jan 1994
ARGELITE 81SF+
K934768 · Argen Precious Metals, Inc. · Dec 1993