← FDA Medical Device Classifications
Handpiece, Air-Powered, Root Canal Irrigation
NYL · Class I — Low Risk (general controls) · Dental · 21 CFR 872.4200
Classification
- FDA Product Code
NYL- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 872.4200
- Review panel
- DE
- Medical specialty
- Dental
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
To clean the root canal prior to filling and used for root canal irrigation.
Market data
- Cleared 510(k) submissions
- 5
- Registered establishments
- 4
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown