Cleared Traditional

K161219 - Zmaxx T Series

K161219 is an FDA 510(k) clearance for Zmaxx T Series, manufactured by Maxx Digm, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K161219 · Maxx Digm, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
272d
Days
Class 2
Risk

K161219 is an FDA 510(k) clearance for the Zmaxx T Series. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Maxx Digm, Inc. (Santa Clara, US). The FDA issued a Cleared decision on January 26, 2017 after a review of 272 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Maxx Digm, Inc. devices

FDA 510(k) Submission Details - K161219

510(k) Number K161219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2016
Decision Date January 26, 2017
Days to Decision 272 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
145d slower than avg
Panel avg: 127d · This submission: 272d
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 290
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K161219.
KATANA Zirconia Block
K170986 · Kuraray Noritake Dental, Inc. · Jul 2017
n!ce Glass Ceramic Blocks for Amann Girrbach
K170420 · Institut Straumann AG · Mar 2017
Cercon
K162888 · Dentsply Sirona · Feb 2017
rainbow Shine
K160079 · Genoss Co., Ltd. · Nov 2016
n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,
K160262 · Institut Straumann AG · Sep 2016
Initial LiSi Block
K153130 · GC America, Inc. · Sep 2016