Cleared Abbreviated

K081884 - MAJOR.BASE 20

K081884 is an FDA 510(k) clearance for MAJOR.BASE 20, manufactured by Major Prodotti Dentari S.P.A.. The device is a Class 2 Dental device with product code EBI cleared through the Abbreviated 510(k) pathway after a 98-day FDA review.

K081884 · Major Prodotti Dentari S.P.A. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
98d
Days
Class 2
Risk

K081884 is an FDA 510(k) clearance for the MAJOR.BASE 20. 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 October 8, 2008 after a review of 98 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K081884

510(k) Number K081884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2008
Decision Date October 08, 2008
Days to Decision 98 days
Submission Type Abbreviated
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
30d faster than avg
Panel avg: 128d · This submission: 98d
Pathway characteristics
Standards-based clearance path.

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 311
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K081884.
PERMA FIBER,MODEL 441
K082180 · Angelus Industria DE Productos Odontologicos · Dec 2008
MAJOR.REPAIR
K082153 · Major Prodotti Dentari S.P.A. · Nov 2008
LANG DENTAL ACRYLIC PRIMER
K081981 · Lang Dental Mfg. Co., Inc. · Nov 2008
TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER
K081514 · Lang Dental Mfg. Co., Inc. · Sep 2008
POLYSTAR 79 DENTURE BASE RESIN
K072851 · Cmp Industries, LLC · Feb 2008
SMH FLEX S
K073040 · Smh Biomaterial AG · Dec 2007
K081884 · MAJOR.BASE 20
Download PDF FDA Summary Major Prodotti Dentar…