# P930021: Biora Emdogain (R)

- Pathway: PMA
- Applicant: The Straumann Company
- Decided: Sep 30, 1996 after 1,169 days
- Product code: NQA (Biologic Material, Dental)
- Device class: 3
- Regulation: 21 CFR 872.3930
- Recalls of this device: 7 (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
- Oct 17, 2025 · Class II · Z-0582-2026: The possibility for this product that is intended for demonstration purposes only to be placed in patients.
- Mar 23, 2018 · Class II · Z-1694-2018: A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
- Mar 23, 2018 · Class II · Z-1693-2018: A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
- Mar 23, 2018 · Class II · Z-1697-2018: A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
- Mar 23, 2018 · Class II · Z-1696-2018: A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
- Mar 23, 2018 · Class II · Z-1698-2018: A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
- Mar 23, 2018 · Class II · Z-1695-2018: A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.

Source page: https://510kreport.com/device/P930021
Methodology: https://510kreport.com/methodology