TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis
FDA premarket approval P980052/S017 · decided 2026-03-06
Approval details
- PMA number
- P980052
- Supplement
- S017
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis
- Generic name
- Joint, temporomandibular, implant
- Applicant
- Stryker Leibinger, GmbH & Co KG
- Date received
- 2025-07-28
- Decision date
- 2026-03-06
- Days to decision
- 221 days
- Decision code
- APPR
- Product code
- LZD
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Freiburg
- Statement
- the implementation of two (2) new sterile barrier heat sealing machines for use in the packaging process of patient-fitted TMJ implant
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