Cleared Traditional

K964038 - CHARISMA F

K964038 is an FDA 510(k) clearance for CHARISMA F, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K964038 · Heraeus Kulzer, Inc. · Dental device
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Apr 1997
Decision
180d
Days
Class 2
Risk

K964038 is an FDA 510(k) clearance for the CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on April 2, 1997 after a review of 180 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K964038

510(k) Number K964038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1996
Decision Date April 02, 1997
Days to Decision 180 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
53d slower than avg
Panel avg: 127d · This submission: 180d
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 K964038.
ENCORE BOND
K971121 · Centrix, Inc. · Jun 1997
SILOC SYSTEM
K970848 · Heraeus Kulzer, Inc. · May 1997
HYBRID RESIN COMPOSITE
K964867 · Parkell, Inc. · Apr 1997
DENTINSENSE B/C
K965138 · Centrix, Inc. · Feb 1997
DENTINSENSE
K964735 · Centrix, Inc. · Feb 1997
PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR
K964525 · Dentsply Intl. · Jan 1997