Cleared Traditional

K162654 - mollosil plus

K162654 is an FDA 510(k) clearance for mollosil plus, manufactured by Detax GmbH & Co. KG. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K162654 · Detax GmbH & Co. KG · Dental device
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Mar 2017
Decision
171d
Days
Class 2
Risk

K162654 is an FDA 510(k) clearance for the mollosil plus. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Detax GmbH & Co. KG (Ettlingen, DE). The FDA issued a Cleared decision on March 13, 2017 after a review of 171 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 Detax GmbH & Co. KG devices

FDA 510(k) Submission Details - K162654

510(k) Number K162654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2016
Decision Date March 13, 2017
Days to Decision 171 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
44d slower than avg
Panel avg: 127d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 239
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