Cleared Traditional

K983966 - NUPRO PROPHYLAXIS PASTE WITH FLOURIDE A...

K983966 is the FDA 510(k) clearance for NUPRO PROPHYLAXIS PASTE WITH FLOURIDE A... by Dentsply Intl.. It is a Class 1 Dental device (product code EJR) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K983966 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
84d
Days
Class 1
Risk

K983966 is an FDA 510(k) clearance for the NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on January 29, 1999 after a review of 84 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 Intl. devices

Submission Details

510(k) Number K983966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1998
Decision Date January 29, 1999
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
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.

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

All 26
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K983966.
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
SATIN PROPHYLAXIS PASTE
K912945 · Dentsply Intl. · Sep 1991
PULPDENT DIAMOND POLISH
K911284 · Pulpdent Corp. · May 1991
PROPHY PASTE
K901580 · Dentsply Intl. · Sep 1990