# K103474: Ena Temp and Enamel Plus Temp (Two Different Proprietary Names for the Same Product)

- Pathway: 510(k) (Traditional)
- Applicant: Micerium S.P.A.
- Decided: Feb 7, 2011 after 73 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 K000894 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000894: C&B Resin Plus Powder/Liquid, Models Retemp A2, A3, A3.5, CL, Retemp B2, B3, C2, D3, WH, Retemp MO, Dental Ventures of America, Inc. (2000) Summary page 1.

## Indications for use
ENA TEMP/ ENAMEL PLUS TEMP is a system of liquid and powder resin available in different colours, for aesthetic temporary crown and bridge. It can be used both in laboratory (by indirect method: diagnostic waxing up or vacuum forming matrix) and in dental practice (by direct method in the mouth: silicone impression or preformed crown).

Source page: https://510kreport.com/device/K103474
Methodology: https://510kreport.com/methodology