# Barrier, Synthetic, Intraoral
> **Product code: NPK** · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.3930
## Classification
- **FDA Product Code:** NPK
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 872.3930
- **Review panel:** DE
- **Medical specialty:** Dental
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 31
- **Registered establishments:** 24
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NPK)
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