Cleared Traditional

K063170 - TENDER FIBER

K063170 is an FDA 510(k) clearance for TENDER FIBER, manufactured by Micerium S.P.A.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K063170 · Micerium S.P.A. · Dental device
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Jan 2007
Decision
86d
Days
Class 2
Risk

K063170 is an FDA 510(k) clearance for the TENDER FIBER. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Micerium S.P.A. (Avegno, Genoa, IT). The FDA issued a Cleared decision on January 12, 2007 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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: 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 Micerium S.P.A. devices

FDA 510(k) Submission Details - K063170

510(k) Number K063170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2006
Decision Date January 12, 2007
Days to Decision 86 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
41d faster than avg
Panel avg: 127d · This submission: 86d
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 186
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K063170.
ION DENTAL RESIN SYSTEM
K072713 · Dentsply International, Inc. · Oct 2007
COE SOFT
K070697 · GC America, Inc. · Mar 2007
COE COMFORT
K070698 · GC America, Inc. · Mar 2007
ECLIPSE WAX REMOVER
K061580 · Dentsply International · Jul 2006
SILKLINE SOFT RELINING KIT, MODEL 28-100100
K060844 · J. Morita USA, Inc. · Jun 2006
MUCOHARD
K053516 · Parkell, Inc. · Jan 2006