FERMIT N PLUS

K003377 · Ivoclar North America, Inc. · EBG · Dec 4, 2000 · Dental

Device Facts

Record IDK003377
Device NameFERMIT N PLUS
ApplicantIvoclar North America, Inc.
Product CodeEBG · Dental
Decision DateDec 4, 2000
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3770
Device ClassClass 2

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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