FDA product code LPG: Material, Dressing, Surgical, Polylactic Acid
LPG is the FDA product code for material, dressing, surgical, polylactic acid. It is a Class III device, reviewed by the Dental panel. Devices under LPG reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 7 recalls for LPG devices.
Classification
| Field | Value |
|---|---|
| Device name | Material, Dressing, Surgical, Polylactic Acid |
| Device class | Class III |
| Review panel | DE — Dental |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LPG devices
7 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-03-28.
Frequently asked questions
What is FDA product code LPG?
LPG is the FDA product code for material, dressing, surgical, polylactic acid. It is a Class III device, reviewed by the Dental panel.
What device class is LPG?
Class III. Typical premarket route: PMA.
Have LPG devices been recalled?
Yes: 7 product recalls across 1 recall events; the most recent began 2013-03-28.
Next steps
- Run an FDA pathway report with predicate devices for product code LPG
- Run a recall and safety report across every LPG manufacturer
- Watch product code LPG 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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