Cleared Traditional

K930455 - CHAMELEON LIGHT/CHEMICAL CURE GLASS ION...

K930455 is the FDA 510(k) clearance for CHAMELEON LIGHT/CHEMICAL CURE GLASS ION... by Voco GmbH. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K930455 · Voco GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
71d
Days
Class 2
Risk

K930455 is an FDA 510(k) clearance for the CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Voco GmbH (St Louis, US). The FDA issued a Cleared decision on April 8, 1993 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Voco GmbH devices

Submission Details

510(k) Number K930455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1993
Decision Date April 08, 1993
Days to Decision 71 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
56d faster than avg
Panel avg: 127d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 254
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K930455.
TEMPIT
K931084 · Centrix, Inc. · May 1993
MULTIPURPOSE RESIN CEMENT
K923473 · Dentsply Intl. · Apr 1993
ARGION DENTAL CEMENT
K926492 · Voco GmbH · Apr 1993
BIFIX DENTAL CEMENT
K926458 · Voco GmbH · Mar 1993
VITA CEREC DUO CEMENT
K925713 · Vident · Feb 1993
3M VITREMER TRI-CURE GLASS IONOMER SYSTEM
K925032 · 3M Company · Dec 1992