← FDA Medical Device Classifications
Intraoral, Dental Foam Protector
PFL · Class I — Low Risk (general controls) · Dental · 21 CFR 872.6890
Classification
- FDA Product Code
PFL- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 872.6890
- Review panel
- DE
- Medical specialty
- Dental
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Intended to provide a soft barrier between wired mouth hardware and oral mucosa.
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 5
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown