Cleared Traditional

K152093 - NobelZygoma 45°

K152093 is an FDA 510(k) clearance for NobelZygoma 45°, manufactured by Nobel Biocare AB. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K152093 · Nobel Biocare AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
232d
Days
Class 2
Risk

K152093 is an FDA 510(k) clearance for the NobelZygoma 45°. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on March 16, 2016 after a review of 232 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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

FDA 510(k) Submission Details - K152093

510(k) Number K152093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2015
Decision Date March 16, 2016
Days to Decision 232 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
105d slower than avg
Panel avg: 127d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 921
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K152093.
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K142313 · Dentis Co., Ltd. · Dec 2015
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K150344 · Dentis Co., Ltd. · Jul 2015