Cleared Traditional

K121698 - NUPRO SENSODYNE PROPHYLAXIS PASTE WITH ...

K121698 is the FDA 510(k) clearance for NUPRO SENSODYNE PROPHYLAXIS PASTE WITH ... by Dentsply International, Inc.. It is a Class 1 Dental device (product code EJR) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K121698 · Dentsply International, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
59d
Days
Class 1
Risk

K121698 is an FDA 510(k) clearance for the NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Dentsply International, Inc. (York, US). The FDA issued a Cleared decision on August 6, 2012 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6030 - 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 International, Inc. devices

Submission Details

510(k) Number K121698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2012
Decision Date August 06, 2012
Days to Decision 59 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 127d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EJR Agent, Polishing, Abrasive, Oral Cavity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6030
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Clinical Evidence

ClinicalTrials.gov
NCT01610167 Completed Interventional Industry-sponsored

NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r)Sensitivity Relief Study

NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r) for the Treatment of Dentin Hypersensitivity.

151
Patients (actual)
1
Site
Treatment
Purpose
Triple
Masking
Condition studied Tooth Hypersensitivity
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Jeffery L. Milleman, DDS, MPA
Sponsor Dentsply International (industry)
Started 2011-09-01 → Primary completion 2011-12-01
Primary outcome
Immediate Sensitivity Relief. Tactile Sensitivity.
Secondary outcome
Extended Sensitivity Relief. Tactile Sensitivity.
View full study on ClinicalTrials.gov

Regulatory Peers - EJR Agent, Polishing, Abrasive, Oral Cavity

All 24
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K121698.
REMIN PRO
K101104 · Voco GmbH · Oct 2010
GC MI PASTE PLUS
K070854 · GC America, Inc. · Apr 2007
ENAMEL PRO
K062166 · Premier Dental Products Co. · Nov 2006
MI PASTE
K042200 · GC America, Inc. · Oct 2004
NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN
K000169 · Dentsply Intl. · Mar 2000
NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN
K983966 · Dentsply Intl. · Jan 1999