Cleared Traditional

K984387 - R-30 AESTHETIC RESTORATIVE

K984387 is an FDA 510(k) clearance for R-30 AESTHETIC RESTORATIVE, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K984387 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
36d
Days
Class 2
Risk

K984387 is an FDA 510(k) clearance for the R-30 AESTHETIC RESTORATIVE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on January 13, 1999 after a review of 36 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K984387

510(k) Number K984387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1998
Decision Date January 13, 1999
Days to Decision 36 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 127d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

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 800
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K984387.
MONOPAQUE
K990315 · Ivoclar North America, Inc. · Mar 1999
DC-CORE
K984097 · S & C Polymer GmbH · Feb 1999
LC MICROHYBRID
K984484 · S & C Polymer GmbH · Jan 1999
ADVENT
K984112 · Bisco, Inc. · Dec 1998
QUADRANT POSTERIOR DENSE
K984044 · Cavex Holland BV · Dec 1998
QUADRANT UNIVERSAL LC
K984041 · Cavex Holland BV · Dec 1998