← FDA Medical Device Classifications
Joint, Temporomandibular, Implant
LZD · Class III — High Risk (PMA approval required, life-sustaining) · Dental · 21 CFR 872.3940
Classification
- FDA Product Code
LZD- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 872.3940
- Review panel
- DE
- Medical specialty
- Dental
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Definition
Call for PMAs to be filed by 3/30/99 per 63 FR 71746 on 12/30/98 - Indicated for reconstruction of the temporomandibular joint.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 8
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown