Cleared Special

K071267 - PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN

K071267 is an FDA 510(k) clearance for PERIOSRP TOOTH ROOT CONDITIONER WITH NO..., manufactured by Novamin Technology, Inc.. The device is a Class 2 Dental device with product code LBH cleared through the Special 510(k) pathway after a 11-day FDA review.

K071267 · Novamin Technology, Inc. · Dental device
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May 2007
Decision
11d
Days
Class 2
Risk

K071267 is an FDA 510(k) clearance for the PERIOSRP TOOTH 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 May 18, 2007 after a review of 11 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K071267

510(k) Number K071267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2007
Decision Date May 18, 2007
Days to Decision 11 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 128d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

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 Peers - LBH Varnish, Cavity

All 131
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K071267.
CERVITEC PLUS
K072338 · Ivoclar Vivadent, Inc. · Sep 2007
ULTRAEZ DESENSITIZING GEL
K061438 · Ultradent Products, Inc. · Jun 2007
ASCENT DENTAL CLEANSER
K070070 · CAO Group, Inc. · May 2007
ACQUASEAL BENZ
K070289 · Acquamed Technologies, Inc. · May 2007
RELIEF ACP ORAL CARE GEL
K062176 · Discus Dental, Inc. · Jan 2007
ENAMEL PRO VARNISH
K062683 · Premier Dental Products Co. · Nov 2006
K071267 · PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN
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