# K132599: Smilebond System

- Pathway: 510(k) (Traditional)
- Applicant: Millennium Company, LLC
- Decided: Feb 25, 2014 after 189 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K913537 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120013: Tempspan Clear Matrix, Pentron Clinical (2012) Summary page 2.

## Cited in the summary but kept off the family tree
- K801830: Model 9300 Electrocardiovalidator, Del Mar Avionics (1980). Our reading of the summary gave K801830, FDA’s number for Model 9300 Electrocardiovalidator (Del Mar Avionics). Its FDA name has none of the distinctive words the summary uses for the device it names, “Silicone Impression Material”. Kept off the family tree. Summary page 2.

## Indications for use
SmileBond Systems Fast Bite Registration Material impression material is used for making impressions of the teeth and gums of patients requiring enhancement of the smile and for bite alignment.

Source page: https://510kreport.com/device/K132599
Methodology: https://510kreport.com/methodology