Cleared Traditional

BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN (K041371) - FDA 510(k) Clearance

Class I Dental device.

K041371 · Novamin Technology, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
91d
Days
Class 1
Risk

K041371 is an FDA 510(k) clearance for the BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Novamin Technology, Inc. (Alachua, US). The FDA issued a Cleared decision on August 23, 2004 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Novamin Technology, Inc. devices

Submission Details

510(k) Number K041371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2004
Decision Date August 23, 2004
Days to Decision 91 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
36d faster than avg
Panel avg: 127d · This submission: 91d
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 76
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K041371.
NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN
K000169 · Dentsply Intl. · Mar 2000
NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN
K983966 · Dentsply Intl. · Jan 1999
SATIN PROPHYLAXIS PASTE
K912945 · Dentsply Intl. · Sep 1991
PROPHY PASTE
K901580 · Dentsply Intl. · Sep 1990
ABRASIVE DISC - POLISHING WHEEL
K872251 · Dentsply Intl. · Jul 1987