FDA product code LZD: Joint, Temporomandibular, Implant
LZD is the FDA product code for joint, temporomandibular, implant. It is a Class III device, regulated under 21 CFR 872.3940 and reviewed by the Dental panel. Devices under LZD reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code. FDA has posted 20 recalls for LZD devices, 4 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Joint, Temporomandibular, Implant |
| Device class | Class III |
| Regulation | 21 CFR 872.3940 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | PMA |
| Implant | Yes |
Recalls for LZD devices
20 product recalls in 7 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-02-11.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code LZD?
LZD is the FDA product code for joint, temporomandibular, implant. It is a Class III device, regulated under 21 CFR 872.3940 and reviewed by the Dental panel.
What device class is LZD?
Class III, regulation 21 CFR 872.3940. Typical premarket route: PMA.
Have LZD devices been recalled?
Yes: 20 product recalls across 7 recall events; the most recent began 2026-02-11.
Next steps
- Run an FDA pathway report with predicate devices for product code LZD
- Run a recall and safety report across every LZD manufacturer
- Watch product code LZD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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