Cleared Traditional

PULPDENT ETCH-RITE ROYALE (K031915) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K031915 · Pulpdent Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
46d
Days
Class 2
Risk

K031915 is an FDA 510(k) clearance for the PULPDENT ETCH-RITE ROYALE. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on August 5, 2003 after a review of 46 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 Pulpdent Corporation devices

Submission Details

510(k) Number K031915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2003
Decision Date August 05, 2003
Days to Decision 46 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
81d faster than avg
Panel avg: 127d · This submission: 46d
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 83
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K031915.
XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE
K070538 · Dentsply Intl. · Mar 2007
ECLIPSE BONDING AGENT
K051707 · Dentsply Intl. · Jul 2005
XENO ADHESIVE WITH ACTIVATOR
K051463 · Dentsply Intl. · Jul 2005
XENO III DENTAL ADHESIVE
K023776 · Dentsply Intl. · Jan 2003
XSE
K011167 · 3M Company · May 2001
PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
K982394 · Dentsply Intl. · Sep 1998