Cleared Traditional

K945604 - ECLIPTOMER

K945604 is the FDA 510(k) clearance for ECLIPTOMER by Bisco, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K945604 · Bisco, Inc. · Dental device
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Jan 1995
Decision
49d
Days
Class 2
Risk

K945604 is an FDA 510(k) clearance for the ECLIPTOMER. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Bisco, Inc. (Itasca, US). The FDA issued a Cleared decision on January 3, 1995 after a review of 49 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 Bisco, Inc. devices

Submission Details

510(k) Number K945604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1994
Decision Date January 03, 1995
Days to Decision 49 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
78d faster than avg
Panel avg: 127d · This submission: 49d
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 K945604.
PERMAQUIK BONDING PRIMER
K951583 · Ultradent Products, Inc. · May 1995
C&B-METABOND RADIOPAQUE POWDER
K950905 · Parkell, Inc. · Apr 1995
PERMALUTE
K950860 · Ultradent Products, Inc. · Mar 1995
PULPDENT DUAL CURE UNFILLED BONDING RESIN
K945112 · Pulpdent Corp. · Dec 1994
OPTIBOND-D
K943738 · Sybron Dental Specialties, Inc. · Sep 1994
PERMAGEN F/DC
K943373 · Ultradent Products, Inc. · Aug 1994