Cleared Traditional

K130991 - NEXXZR(TM)T AND NEXXZR(TM)S

K130991 is an FDA 510(k) clearance for NEXXZR(TM)T AND NEXXZR(TM)S, manufactured by Sagemax Bioceramics, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 306-day FDA review.

K130991 · Sagemax Bioceramics, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
306d
Days
Class 2
Risk

K130991 is an FDA 510(k) clearance for the NEXXZR(TM)T AND NEXXZR(TM)S. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Sagemax Bioceramics, Inc. (Federal Way, US). The FDA issued a Cleared decision on February 10, 2014 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K130991

510(k) Number K130991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2013
Decision Date February 10, 2014
Days to Decision 306 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
178d slower than avg
Panel avg: 128d · This submission: 306d
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 472
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K130991.
STARCERAM
K140924 · H.C. Starck Ceramics GmbH · Jun 2014
LUXER SHADED ZIRCONIA
K140070 · Continental Dental Ceramics, Inc. · May 2014
ZIRTOUGH
K133211 · Kuraray Noritake Dental, Inc. · Mar 2014
VITA SUPRINITY(R)
K132070 · Vita Zahnfabrik H.Rauter GmbH & Co. · Jan 2014
STARCERAM
K133213 · H.C. Starck Ceramics GmbH · Dec 2013
BECE CAD ZIRKON HT+
K132102 · Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO · Nov 2013