← FDA Medical Device Classifications
Non-Irrigation Endosseous Dental Implant Drill Bits
QRQ · Class I — Low Risk (general controls) · Dental · 21 CFR 872.3980
Classification
- FDA Product Code
QRQ- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 872.3980
- Review panel
- DE
- Medical specialty
- Dental
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
The device is intended to prepare the site for placement of endosseous dental implants. It is to be used at a low speed without irrigation.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 22
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown