Cleared Traditional

K972594 - METALPRIMER II

K972594 is the FDA 510(k) clearance for METALPRIMER II by GC America, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K972594 · GC America, Inc. · Dental device
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Aug 1997
Decision
46d
Days
Class 2
Risk

K972594 is an FDA 510(k) clearance for the METALPRIMER II. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on August 26, 1997 after a review of 46 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 GC America, Inc. devices

Submission Details

510(k) Number K972594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1997
Decision Date August 26, 1997
Days to Decision 46 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
81d faster than avg
Panel avg: 127d · This submission: 46d
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 248
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K972594.
KERR NEXUS ONE BOTTLE ADHESIVE
K972858 · Sybron Dental Specialties, Inc. · Sep 1997
DENTIN CONDITIONING AND ADHESIVE (BOND 1)
K973388 · Jeneric/Pentron, Inc. · Sep 1997
EASY BOND
K972421 · Parkell, Inc. · Aug 1997
ENCORE BOND
K971121 · Centrix, Inc. · Jun 1997
SILOC SYSTEM
K970848 · Heraeus Kulzer, Inc. · May 1997
HYBRID RESIN COMPOSITE
K964867 · Parkell, Inc. · Apr 1997