Cleared Traditional

K062515 - RETENTION FLOW OPAQUE

K062515 is an FDA 510(k) clearance for RETENTION FLOW OPAQUE, manufactured by Heraeus Kulzer,GmbH. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K062515 · Heraeus Kulzer,GmbH · Dental device
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Nov 2006
Decision
86d
Days
Class 2
Risk

K062515 is an FDA 510(k) clearance for the RETENTION FLOW OPAQUE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Heraeus Kulzer,GmbH (South Bend, US). The FDA issued a Cleared decision on November 22, 2006 after a review of 86 days - a notably fast clearance cycle.

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: 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 Heraeus Kulzer,GmbH devices

FDA 510(k) Submission Details - K062515

510(k) Number K062515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2006
Decision Date November 22, 2006
Days to Decision 86 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 127d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

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 725
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K062515.
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K062343 · Voco GmbH · Nov 2006
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K061906 · Kuraray Medical, Inc. · Sep 2006