# K033022: Protemp 3 Garant

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe AG Dental Products
- Decided: Nov 21, 2003 after 57 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001114 (2000). 2 ancestors in all.
46 later devices descend from it; 4 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002364: Protemp H, Espe Dental AG (2000) Summary page 2.
- K001114: 3M Quik Temp Temporization Material, 3M Company (2000) Summary page 2.

## Most influential descendants
- K043043: Hermes Bond 2 (2005), 37 descendants of its own
- K071131: UNO (2007), 35 descendants of its own
- K110302: Adhesive Exl-759 (2011), 34 descendants of its own
- K112118: Dreambond (2011), 8 descendants of its own
- K161051: All-Bond Universal w/BAC (not finalized) (2016), 6 descendants of its own

## Indications for use
Fabrication of temporary crowns, bridges, inlays, onlays and veneers. Crown lining material for 3M ESPE Prefabricated Temporary Crowns.

Source page: https://510kreport.com/device/K033022
Methodology: https://510kreport.com/methodology