FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Joint, Temporomandibular, Implant
PMA: P980052
·
Supplement: S011
·
Decision Aug 31, 2022
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Joint, Temporomandibular, Implant
- Trade Name
- TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis
- PMA Number
- P980052
- Supplement Number
- S011
- Device Class
- FDA Class 3
- Product Code
- LZD
- Generic Name
- Joint, temporomandibular, implant
- Regulation Number
- 872.3940
- Medical Specialty
- Dental
- Advisory Committee
- Dental
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- August 31, 2022
- Date Received
- August 22, 2022
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Addition of a back-up Ethylene Oxide Sterilizer.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZD | Joint, Temporomandibular, Implant | FDA class 3 | Dental |