← FDA Medical Device Classifications

Restoration, Porcelain-Fused-To-Metal

NSO · Not classified · Unknown

Classification

FDA Product Code
NSO
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 porecelain-fused-to-metal restorations are porcelain-fused-to-metal crown and bridge restorations that are manufactured as finished products from porcelain and noble or base metal alloys.

Market data

Cleared 510(k) submissions
0
Registered establishments
140

Source

Authoritative
FDA Device Classification database
Machine
JSON-LD · Markdown