← FDA Medical Device Classifications

Restoration, Resin

NSM · Not classified · Unknown

Classification

FDA Product Code
NSM
Device class
Not classified
Regulation
Review panel
DE
Medical specialty
Unknown
Submission type
7
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

Foreign dental lab manufactured resin restorations are permanent restorations that are manufactured as finished products from resins.

Market data

Cleared 510(k) submissions
0
Registered establishments
56

Source

Authoritative
FDA Device Classification database
Machine
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