# K062166: Enamel Pro

- Pathway: 510(k) (Traditional)
- Applicant: Premier Dental Products Co.
- Decided: Nov 21, 2006 after 116 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K102053: Butler Calci-Flor Prophylaxis Paste (2011), 0 descendants of its own
- K100539: Preventech Prophylaxis Paste with Fluoride (2010), 0 descendants of its own

## Indications for use
To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.

Source page: https://510kreport.com/device/K062166
Methodology: https://510kreport.com/methodology