Cleared Traditional

K091096 - NATURAZ SERIES, MODEL B16,B20, B42, B60, B98, B100

K091096 is an FDA 510(k) clearance for NATURAZ SERIES, manufactured by Dental Solutions, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K091096 · Dental Solutions, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
63d
Days
Class 2
Risk

K091096 is an FDA 510(k) clearance for the NATURAZ SERIES, MODEL B16,B20, B42, B60, B98, B100. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Dental Solutions, Inc. (Beverly, US). The FDA issued a Cleared decision on June 18, 2009 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 Dental Solutions, Inc. devices

FDA 510(k) Submission Details - K091096

510(k) Number K091096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2009
Decision Date June 18, 2009
Days to Decision 63 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
64d faster than avg
Panel avg: 127d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 311
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K091096.
ELEGANT
K091826 · 3M Espe AG Dental Products · Sep 2009
BELLUS SHADING KIT
K090718 · 3M Espe AG Dental Products · Sep 2009
QUATTRO PORCELAIN SYSTEM
K091706 · Dentsply International, Inc. · Aug 2009
GC AADVA ZR DISK
K082740 · GC America, Inc. · Nov 2008
ZENO AI ECO DISC
K082257 · Wieland Dental + Technik GmbH & Co. KG · Sep 2008
VINTAGE ART
K080834 · Shofu Dental Corp. · Jun 2008