Cleared Traditional

K936222 - DENTIN CONDITIONING AND ADHESIVE SYSTEM

K936222 is an FDA 510(k) clearance for DENTIN CONDITIONING AND ADHESIVE SYSTEM, manufactured by Jeneric/Pentron, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K936222 · Jeneric/Pentron, Inc. · Dental device
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Mar 1994
Decision
76d
Days
Class 2
Risk

K936222 is an FDA 510(k) clearance for the DENTIN CONDITIONING AND ADHESIVE SYSTEM. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on March 15, 1994 after a review of 76 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 Jeneric/Pentron, Inc. devices

FDA 510(k) Submission Details - K936222

510(k) Number K936222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1993
Decision Date March 15, 1994
Days to Decision 76 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 127d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

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 317
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K936222.
SCOTCHBOND MULTI-PURPOSE PLUS DENTAL ADHESIVE SYSTEM
K942493 · 3M Company · Jul 1994
FLUORIDE-PSA PRIME/ADHESIVE
K941572 · Dentsply Intl. · Jun 1994
OPTIBOND
K940513 · Kerr Corporation (Danbury) · Apr 1994
GC FUJI COAT LC
K935961 · GC America, Inc. · Mar 1994
ATTACHMENT BOND
K935735 · Heraeus Kulzer, Inc. · Mar 1994
BISCO DUO LINK D/C LUTING COMPOSITE
K934596 · Bisco, Inc. · Jan 1994