Cleared Traditional

K082153 - MAJOR.REPAIR

K082153 is an FDA 510(k) clearance for MAJOR.REPAIR, manufactured by Major Prodotti Dentari S.P.A.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K082153 · Major Prodotti Dentari S.P.A. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
118d
Days
Class 2
Risk

K082153 is an FDA 510(k) clearance for the MAJOR.REPAIR. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Major Prodotti Dentari S.P.A. (Monacalieri (Torino), IT). The FDA issued a Cleared decision on November 25, 2008 after a review of 118 days - within the typical 510(k) review window.

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 Major Prodotti Dentari S.P.A. devices

FDA 510(k) Submission Details - K082153

510(k) Number K082153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2008
Decision Date November 25, 2008
Days to Decision 118 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
9d faster than avg
Panel avg: 127d · This submission: 118d
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 195
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K082153.
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COE COMFORT
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