Cleared Traditional

K053060 - TCS UNBREAKABLE

K053060 is an FDA 510(k) clearance for TCS UNBREAKABLE, manufactured by Thermoplastic Comfort Systems, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K053060 · Thermoplastic Comfort Systems, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
262d
Days
Class 2
Risk

K053060 is an FDA 510(k) clearance for the TCS UNBREAKABLE. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Thermoplastic Comfort Systems, Inc. (Signal Hill, US). The FDA issued a Cleared decision on July 20, 2006 after a review of 262 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 Thermoplastic Comfort Systems, Inc. devices

FDA 510(k) Submission Details - K053060

510(k) Number K053060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2005
Decision Date July 20, 2006
Days to Decision 262 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
135d slower than avg
Panel avg: 127d · This submission: 262d
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 176
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K053060.
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
BIOSPLINT SPLINTING RIBBON
K053328 · Satelec · Jan 2006