Cleared Traditional

K973388 - DENTIN CONDITIONING AND ADHESIVE (BOND 1)

K973388 is an FDA 510(k) clearance for DENTIN CONDITIONING AND ADHESIVE (BOND 1), 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 3-day FDA review.

K973388 · Jeneric/Pentron, Inc. · Dental device
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Sep 1997
Decision
3d
Days
Class 2
Risk

K973388 is an FDA 510(k) clearance for the DENTIN CONDITIONING AND ADHESIVE (BOND 1). 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 September 12, 1997 after a review of 3 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 - K973388

510(k) Number K973388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1997
Decision Date September 12, 1997
Days to Decision 3 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
124d faster than avg
Panel avg: 127d · This submission: 3d
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 K973388.
2 BOND 2
K971733 · Heraeus Kulzer, Inc. · Oct 1997
SOLITAIRE
K972101 · Heraeus Kulzer, Inc. · Sep 1997
KERR NEXUS ONE BOTTLE ADHESIVE
K972858 · Sybron Dental Specialties, Inc. · Sep 1997
EASY BOND
K972421 · Parkell, Inc. · Aug 1997
METALPRIMER II
K972594 · GC America, Inc. · Aug 1997
ENCORE BOND
K971121 · Centrix, Inc. · Jun 1997