# P990033: Pepgen P-15

- Pathway: PMA
- Applicant: Ceramed Corp.
- Decided: Oct 25, 1999 after 123 days
- Product code: NPZ (Bone Grafting Material, Dental, With Biologic Component)
- Device class: 3
- Regulation: 21 CFR 872.3930
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Feb 17, 2005 · Not classified · Z-0579-05: PepGen P-15 Putty kit was labeled with the incorrect expiration date.

Source page: https://510kreport.com/device/P990033
Methodology: https://510kreport.com/methodology