Cleared Traditional

NUMBER 21 R/R SYSTEM (K841457) - FDA 510(k) Clearance

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

K841457 · Pentron Corp. · Dental device
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May 1984
Decision
43d
Days
Class 2
Risk

K841457 is an FDA 510(k) clearance for the NUMBER 21 R/R SYSTEM. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Pentron Corp. (Mchenry, US). The FDA issued a Cleared decision on May 22, 1984 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 Pentron Corp. devices

Submission Details

510(k) Number K841457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1984
Decision Date May 22, 1984
Days to Decision 43 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 127d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 83
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K841457.
ETCH AND BOND
K852660 · Dentsply Intl. · Jul 1985
OPAQUER/BONDING AGENT
K851056 · Dentsply Intl. · Apr 1985
JOHNSON & JOHNSON FLAVORED ETCHING GEL
K842078 · Johnson & Johnson Professionals, Inc. · Jul 1984
ETCHING GEL
K833718 · Johnson & Johnson Professionals, Inc. · Dec 1983
DENTIN BONDING AGENT
K833473 · Johnson & Johnson Professionals, Inc. · Dec 1983
MICRODAPT DENTAL RESTORATIVE BONDING
K830387 · Johnson & Johnson Professionals, Inc. · Mar 1983