Cleared Traditional

K870209 - NEXADENT (DENTAL CEMENT)

K870209 is an FDA 510(k) clearance for NEXADENT (DENTAL CEMENT), manufactured by Bionexus, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K870209 · Bionexus, Inc. · Dental device
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Feb 1987
Decision
30d
Days
Class 2
Risk

K870209 is an FDA 510(k) clearance for the NEXADENT (DENTAL CEMENT). Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Bionexus, Inc. (Raleigh, US). The FDA issued a Cleared decision on February 19, 1987 after a review of 30 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 Bionexus, Inc. devices

FDA 510(k) Submission Details - K870209

510(k) Number K870209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1987
Decision Date February 19, 1987
Days to Decision 30 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 127d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

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 434
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K870209.
INSURE PORCELAIN VENEER BONDING SYSTEM
K873356 · Cosmedent, Inc. · Dec 1987
LIGHT-CURED PERIODONTAL DRESSING
K864720 · Dentsply Intl. · Apr 1987
BONDEX* GLASS IONOMER CEMENT
K870211 · Johnson & Johnson Professionals, Inc. · Mar 1987
BOSTON POST CEMENT
K870334 · Scientific Pharmaceuticals, Inc. · Feb 1987
MODI. DICOR CASTABLE CERAMIC/ALL PORCELAIN BRIDGES
K864725 · Dentsply Intl. · Jan 1987
3M GLASS IONOMER LINER
K864270 · 3M Company · Dec 1986