SELF CURE BONDING AGENT

K962277 · Dent Zar, Inc. · KLE · Jul 3, 1996 · Dental

Device Facts

Record IDK962277
Device NameSELF CURE BONDING AGENT
ApplicantDent Zar, Inc.
Product CodeKLE · Dental
Decision DateJul 3, 1996
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3200
Device ClassClass 2

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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