← FDA Medical Device Classifications
Abutment, Implant, Dental, Endosseous
NHA · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.3630
Classification
- FDA Product Code
NHA- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 872.3630
- Review panel
- DE
- Medical specialty
- Dental
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Definition
To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Market data
- Cleared 510(k) submissions
- 702
- Registered establishments
- 378
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown