Cleared Traditional

K130991 - NEXXZR(TM)T AND NEXXZR(TM)S (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K130991 · Sagemax Bioceramics, Inc. · Dental device
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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.

View all Sagemax Bioceramics, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
179d slower than avg
Panel avg: 127d · This submission: 306d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

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