Cleared Traditional

TREFOIL System (K172352) - FDA 510(k) Clearance

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

K172352 · Nobel Biocare AB · Dental device
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Oct 2017
Decision
78d
Days
Class 2
Risk

K172352 is an FDA 510(k) clearance for the TREFOIL System. 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 October 20, 2017 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nobel Biocare AB devices

Submission Details

510(k) Number K172352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2017
Decision Date October 20, 2017
Days to Decision 78 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
49d faster than avg
Panel avg: 127d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 304
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K172352.
AR_N Type Implant System
K171297 · Biotem Co., Ltd. · Jan 2018
SPI Dental Implant System
K172240 · Msi France · Jan 2018
Straumann Dental Implant System
K171784 · Straumann USA, LLC · Jan 2018
TREFOIL System
K170135 · Nobel Biocare AB · May 2017
NobelZygoma 0°
K161598 · Nobel Biocare AB · Mar 2017
GC AADVA IMPLANT SYSTEM
K093749 · GC America, Inc. · Dec 2010