Cleared Traditional

K041371 - BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN

K041371 is an FDA 510(k) clearance for BUTLER NUCARE PROPHYLAXIS PASTE WITH NO..., manufactured by Novamin Technology, Inc.. The device is a Class 1 Dental device with product code EJR cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K041371 · Novamin Technology, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K041371

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 128d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

EJR Device Classification - Class 1, General Controls

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 65
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K041371.
ENAMEL PRO
K062166 · Premier Dental Products Co. · Nov 2006
GELATO PROPHYLAXIS PASTE
K042048 · Deepak Products, Inc. · Oct 2004
MI PASTE
K042200 · GC America, Inc. · Oct 2004
ZIRCON-F PROPHYLAXIS PASTE
K040988 · Pascal Co., Inc. · Jul 2004
PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE
K033785 · Discus Dental, Inc. · Jun 2004
RADENT PROPHY PASTE
K040661 · Pascal Co., Inc. · Jun 2004
K041371 · BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN
Download PDF FDA Summary Novamin Technology, I…