# K002989: Proclude

- Pathway: 510(k) (Traditional)
- Applicant: Ortek Therapeutics, Inc.
- Decided: Dec 14, 2000 after 80 days
- Product code: EJR (Agent, Polishing, Abrasive, Oral Cavity)
- Device class: 1
- Regulation: 21 CFR 872.6030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K024343: Butler Gum Prophy Paste with Novamin (2003), 17 descendants of its own
- K040858: Oralief Therapy for Sensitive Teeth (2004), 7 descendants of its own
- K041371: Butler Nucare Prophylaxis Paste with Novamin (2004), 3 descendants of its own
- K040473: Oravive Tooth Revitalizing Paste (2004), 3 descendants of its own
- K120176: Senzzzzz Away (2012), 2 descendants of its own

Source page: https://510kreport.com/device/K002989
Methodology: https://510kreport.com/methodology