Cleared Traditional

K033295 - BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN

K033295 is an FDA 510(k) clearance for BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN, manufactured by Novamin Technology, Inc.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K033295 · Novamin Technology, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
14d
Days
Class 2
Risk

K033295 is an FDA 510(k) clearance for the BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Novamin Technology, Inc. (Alachua, US). The FDA issued a Cleared decision on October 28, 2003 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - 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.

FDA 510(k) Submission Details - K033295

510(k) Number K033295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2003
Decision Date October 28, 2003
Days to Decision 14 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 128d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

LBH Device Classification - Class 2, Special Controls

Product Code LBH Varnish, Cavity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
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 Consultant

N.V. Kema
HARRY VAN VUGT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LBH Varnish, Cavity

All 131
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K033295.
ORALIEF THERAPY FOR SENSITIVE TEETH
K040858 · Novamin Technology, Inc. · Sep 2004
ORAVIVE TOOTH REVITALIZING PASTE
K040473 · Novamin Technology, Inc. · Mar 2004
VARNISHAMERICA
K040098 · Medical Products Laboratories, Inc. · Feb 2004
VIVASENS
K030922 · Ivoclar Vivadent, Inc. · Oct 2003
FLUORIDE VARNISH
K031932 · Dentsply Intl. · Sep 2003
FLUORILAQ
K030488 · Pascal Co., Inc. · May 2003
K033295 · BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN
Download PDF FDA Summary Novamin Technology, I…