Cleared Traditional

K950905 - C&B-METABOND RADIOPAQUE POWDER

K950905 is the FDA 510(k) clearance for C&B-METABOND RADIOPAQUE POWDER by Parkell, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K950905 · Parkell, Inc. · Dental device
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Apr 1995
Decision
41d
Days
Class 2
Risk

K950905 is an FDA 510(k) clearance for the C&B-METABOND RADIOPAQUE POWDER. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on April 10, 1995 after a review of 41 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 Parkell, Inc. devices

Submission Details

510(k) Number K950905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1995
Decision Date April 10, 1995
Days to Decision 41 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
86d faster than avg
Panel avg: 127d · This submission: 41d
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 K950905.
PRIME & BOND DIRECT COMPOSITE BONDING AGENT
K951864 · Dentsply Intl. · May 1995
PERMAQUIK BONDING PRIMER
K951867 · Ultradent Products, Inc. · May 1995
PERMAQUIK BONDING PRIMER
K951583 · Ultradent Products, Inc. · May 1995
PERMALUTE
K950860 · Ultradent Products, Inc. · Mar 1995
ECLIPTOMER
K945604 · Bisco, Inc. · Jan 1995
PULPDENT DUAL CURE UNFILLED BONDING RESIN
K945112 · Pulpdent Corp. · Dec 1994