Cleared Traditional

NobelProcera HT ML FCZ Bridge (K162043) - FDA 510(k) Clearance

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

K162043 · Nobel Biocare AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
120d
Days
Class 2
Risk

K162043 is an FDA 510(k) clearance for the NobelProcera HT ML FCZ Bridge. Classified as Teeth, Porcelain (product code ELL), Class II - Special Controls.

Submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on November 22, 2016 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3920 - 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 Nobel Biocare AB devices

Submission Details

510(k) Number K162043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2016
Decision Date November 22, 2016
Days to Decision 120 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
7d faster than avg
Panel avg: 127d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELL Teeth, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3920
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 Consultant

Nobel Biocare USA, LLC
Charlemagne Chua

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ELL Teeth, Porcelain

All 14
Devices cleared under the same product code (ELL) and FDA review panel - the closest regulatory comparables to K162043.
Additive Manufacturing Zirconia Customized Restoration
K240586 · Hangzhou Thales Medtech Co., Ltd. · Oct 2024
Franz Zirconia Dental Crown
K203072 · Franz Biotech, Inc. · Jan 2022
NobelProcera HT ML Full Contour Zirconia Crown
K153534 · Nobel Biocare AB · Jun 2016
PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013
K071182 · Nobel Biocare AB · Jul 2007
PROCERA BRIDGE ZIRCONIA
K041283 · Nobel Biocare AB · May 2004
PROCEARA COPINGS AND PONTIC
K032562 · Nobel Biocare AB · Feb 2004