Cleared Traditional

BioHPP - breCAM.BioHPP (K152113) - FDA 510(k) Clearance

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

K152113 · Bredent GmbH & Co. KG · Dental device
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Jul 2016
Decision
358d
Days
Class 2
Risk

K152113 is an FDA 510(k) clearance for the BioHPP - breCAM.BioHPP. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Bredent GmbH & Co. KG (Senden, DE). The FDA issued a Cleared decision on July 21, 2016 after a review of 358 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 Bredent GmbH & Co. KG devices

Submission Details

510(k) Number K152113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2015
Decision Date July 21, 2016
Days to Decision 358 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
231d slower than avg
Panel avg: 127d · This submission: 358d
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

All 292
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