Cleared Traditional

R1, R2, AND R1+ (K922954) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K922954 · Jeneric/Pentron, Inc. · Dental device
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Jul 1993
Decision
399d
Days
Class 2
Risk

K922954 is an FDA 510(k) clearance for the R1, R2, AND R1+. 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 July 22, 1993 after a review of 399 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K922954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1992
Decision Date July 22, 1993
Days to Decision 399 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
272d slower than avg
Panel avg: 127d · This submission: 399d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 14
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K922954.
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
DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET.
K920561 · Ivoclar North America, Inc. · Mar 1992
PARTIAL DENTURE ALLOY
K860437 · Dentsply Intl. · Mar 1986
BASE METAL ALLOY
K842551 · Dentsply Intl. · Aug 1984