Cleared Traditional

K082180 - PERMA FIBER,MODEL 441

Also marketed or referenced as:
PERMA MESH, MODEL 440

K082180 is an FDA 510(k) clearance for PERMA FIBER, manufactured by Angelus Industria DE Productos Odontologicos. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K082180 · Angelus Industria DE Productos Odontologicos · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
138d
Days
Class 2
Risk

K082180 is an FDA 510(k) clearance for the PERMA FIBER,MODEL 441. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Angelus Industria DE Productos Odontologicos (San Diego, US). The FDA issued a Cleared decision on December 17, 2008 after a review of 138 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.

FDA 510(k) Submission Details - K082180

510(k) Number K082180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2008
Decision Date December 17, 2008
Days to Decision 138 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
10d slower than avg
Panel avg: 128d · This submission: 138d
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 290
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K082180.
TOKUYAMA TISSUECARE
K081554 · Tokuyama Dental Corporation · Mar 2009
BIOCRYL X
K083479 · Great Lakes Orthodontics, Ltd. · Feb 2009
CFS FLEXIBLE
K081537 · Comfort and Flexible Systems · Jan 2009
MAJOR.REPAIR
K082153 · Major Prodotti Dentari S.P.A. · Nov 2008
LANG DENTAL ACRYLIC PRIMER
K081981 · Lang Dental Mfg. Co., Inc. · Nov 2008
MAJOR.BASE 20
K081884 · Major Prodotti Dentari S.P.A. · Oct 2008