Cleared Traditional

Pekkton Ivory (K170102) - FDA 510(k) Clearance

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

K170102 · Cendres & Metaux SA · Dental device
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Nov 2017
Decision
306d
Days
Class 2
Risk

K170102 is an FDA 510(k) clearance for the Pekkton Ivory. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Cendres & Metaux SA (Biel/Bienne, CH). The FDA issued a Cleared decision on November 13, 2017 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 872.3690 - 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 Cendres & Metaux SA devices

Submission Details

510(k) Number K170102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2017
Decision Date November 13, 2017
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 EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

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