Cleared Traditional

K053516 - MUCOHARD

K053516 is an FDA 510(k) clearance for MUCOHARD, manufactured by Parkell, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K053516 · Parkell, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
41d
Days
Class 2
Risk

K053516 is an FDA 510(k) clearance for the MUCOHARD. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on January 26, 2006 after a review of 41 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.

FDA 510(k) Submission Details - K053516

510(k) Number K053516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2005
Decision Date January 26, 2006
Days to Decision 41 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
87d faster than avg
Panel avg: 128d · This submission: 41d
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 331
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K053516.
FLEXO DENTAL RESIN MATERIAL
K061501 · Aci, Inc. · Jul 2006
TCS UNBREAKABLE
K053060 · Thermoplastic Comfort Systems, Inc. · Jul 2006
SILKLINE SOFT RELINING KIT, MODEL 28-100100
K060844 · J. Morita USA, Inc. · Jun 2006
BIOSPLINT SPLINTING RIBBON
K053328 · Satelec · Jan 2006
DENTAPLAST HOT, MODEL 16-XXX
K052780 · Bredent-Products For the Dental Technician Laborat · Dec 2005
FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000
K052073 · Schutz-Dental GmbH · Oct 2005
K053516 · MUCOHARD
Download PDF FDA Summary Parkell, Inc.