Cleared Traditional

K932013 - CHARISMA -- MODIFIED

K932013 is the FDA 510(k) clearance for CHARISMA -- MODIFIED by Heraeus Kulzer, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K932013 · Heraeus Kulzer, Inc. · Dental device
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Jul 1993
Decision
76d
Days
Class 2
Risk

K932013 is an FDA 510(k) clearance for the CHARISMA -- MODIFIED. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Irvine, US). The FDA issued a Cleared decision on July 8, 1993 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K932013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1993
Decision Date July 08, 1993
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.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 612
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K932013.
VLC DR MATERIAL
K932395 · Dentsply Intl. · Aug 1993
BISCO D/C CORE COMPOSITE
K930405 · Bisco, Inc. · Aug 1993
VARIOLINK
K931309 · Ivoclar North America, Inc. · Jul 1993
DENTIN BONDING AGENT
K920533 · Confi-Dental Products Co. · May 1993
VIVALUX
K926556 · Ivoclar North America, Inc. · Apr 1993
CLIP
K926418 · Voco GmbH · Mar 1993