# K180562: Temp Basic, Temp Premium, Temp Premium Flexible, Multistratum Flexible, Therapon, Try-in, Burnout, Try-in & Burnout

- Pathway: 510(k) (Traditional)
- Applicant: Zirkonzahn GmbH
- Decided: Jun 28, 2018 after 115 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: 4 generations back to K924830 (1994). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150432: Idodentine Disc, Idodentine Block, Union Dental S.A. (2015) Summary page 5.

## Most influential descendants
- K183337: LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 (2019), 0 descendants of its own

## Indications for use
The resin discs TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE and THERAPON are polymethylmethacrylate and polycarbonate discs indicated to manufacture temporary anterior and posterior crowns and bridges, with up to two adjacent pontics, that can be kept in the mouth for up to 12 months. TEMP BASIC are PMMA discs intended for the fabrication of temporary anterior crowns and bridges, with up to one adjacent pontic, with a maximum recommended usage time of 12 months. TRY-IN, BURNOUT and TRY-IN & BURNOUT are PMMA discs intended for the fabrication of temporary crowns and bridges that can be kept in the mouth for up to 24 hours as for TRY-IN, and up to 60 minutes as for BURNOUT and TRY-IN &BURNOUT.

Source page: https://510kreport.com/device/K180562
Methodology: https://510kreport.com/methodology