FDA product code NPK

Barrier, Synthetic, Intraoral

Dental·Class 2·21 CFR 872.3930·Implantable
US regulatory classifications
US Product Code (FDA)
NPK
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 872.3930
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Medical specialty
Dental
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
Definition

A synthetic dental barrier is a synthetic material device, such as ptfe, intended to aid in guided tissue and/or bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials.

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About this record

Barrier, Synthetic, Intraoral is a medical device type in the Dental specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.