Cleared Traditional

K053328 - BIOSPLINT SPLINTING RIBBON

K053328 is an FDA 510(k) clearance for BIOSPLINT SPLINTING RIBBON, manufactured by Satelec. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K053328 · Satelec · Dental device
Download Printable Device Report (PDF)
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Jan 2006
Decision
55d
Days
Class 2
Risk

K053328 is an FDA 510(k) clearance for the BIOSPLINT SPLINTING RIBBON. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Satelec (Mt. Laurel, US). The FDA issued a Cleared decision on January 25, 2006 after a review of 55 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 Satelec devices

FDA 510(k) Submission Details - K053328

510(k) Number K053328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2005
Decision Date January 25, 2006
Days to Decision 55 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 127d · This submission: 55d
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 156
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K053328.
ECLIPSE WAX REMOVER
K061580 · Dentsply International · Jul 2006
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K060844 · J. Morita USA, Inc. · Jun 2006
MUCOHARD
K053516 · Parkell, Inc. · Jan 2006
NATURE-CRYL HI PLUS
K051358 · GC America, Inc. · Jul 2005
PALAIMPACT
K043504 · Heraeus Kulzer, Inc. · Jan 2005
VERSYO.DIRECT
K043295 · Heraeus Kulzer, Inc. · Jan 2005