Perma Fiber,Model 441; Perma Mesh, Model 440

FDA 510(k) K082180 · Angelus Industria DE Productos Odontologicos

Substantially Equivalent

510(k) numberK082180

Submission

Device name
Perma Fiber,Model 441; Perma Mesh, Model 440
Applicant
Angelus Industria DE Productos Odontologicos
San Diego, CA, US
Received
August 1, 2008
Decision date
December 17, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EBI – Resin, Denture, Relining, Repairing, Rebasing
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3760
Specialty
Dental

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Questions and answers

When was Perma Fiber,Model 441; Perma Mesh, Model 440 cleared by the FDA?

Perma Fiber,Model 441; Perma Mesh, Model 440 (K082180) received a 510(k) decision of Substantially Equivalent on December 17, 2008, 138 days after the submission was received.

What is the product code of K082180?

The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.